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Ketoconazole

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1. Ketoconazole HRA (ketoconazole), imidazole - Cushing?s syndrome

Ketoconazole HRA (ketoconazole), imidazole - Cushing?s syndrome KETOCONAZOLE SUMMARY CT14104

2015 Haute Autorite de sante

2. Physiological based pharmacokinetic modeling to estimate in vivo Ki of ketoconazole on renal P-gp using human drug-drug interaction study result of fesoterodine and ketoconazole. (Abstract)

Physiological based pharmacokinetic modeling to estimate in vivo Ki of ketoconazole on renal P-gp using human drug-drug interaction study result of fesoterodine and ketoconazole. This study was conducted to estimate in vivo inhibition constant (Ki) of ketoconazole on renal P-glycoprotein (P-gp) using human drug-drug interaction (DDI) study result of fesoterodine and ketoconazole. Fesoterodine is a prodrug which is extensively hydrolyzed by non-specific esterases to the active metabolite 5 (...) -hydroxymethyl tolterodine (5-HMT). 5-HMT is then further metabolized via Cytochrome P450 (CYP) 2D6 and CYP3A4. It is reported that 5-HMT is a substrate of P-gp whereas fesoterodine is not. Renal clearance of 5-HMT is approximately two-times greater than renal glomerular filtration rate. This suggests the possibility that renal clearance of 5-HMT involves secretion by P-gp. Utilizing the available pharmacokinetic characteristics of fesoterodine and 5-HMT, we estimated in vivo Ki of ketoconazole on P-gp

2018 Drug metabolism and pharmacokinetics Controlled trial quality: uncertain

3. Ketoconazole and endogenous Cushing's syndrome: effective but tricky to use

Ketoconazole and endogenous Cushing's syndrome: effective but tricky to use Prescrire IN ENGLISH - Spotlight ''Ketoconazole and endogenous Cushing's syndrome: effective but tricky to use'', 1 March 2016 {1} {1} {1} | | > > > Ketoconazole and endogenous Cushing's syndrome: effective but tricky to use Spotlight Every month, the subjects in Prescrire’s Spotlight. 100 most recent :  |   |   |   |   |   |   |   |   |  Spotlight (...) Ketoconazole and endogenous Cushing's syndrome: effective but tricky to use FEATURED REVIEW Endogenous Cushing's syndrome is a rare but serious disease. Ketoconazole was effective in over 50% of cases in non-comparative series in a total of 800 patients. However, ketoconazole is hepatotoxic and interacts with many other drugs. Full review (2 pages) available for download by subscribers. Summary Endogenous Cushing's syndrome is caused by chronic excessive secretion of cortisol, a glucocorticoid, which

2016 Prescrire

4. A highly sensitive LC-MS/MS method for determination of ketoconazole in human plasma: Application to a clinical study of the exposure to ketoconazole in patients after topical administration. (Abstract)

A highly sensitive LC-MS/MS method for determination of ketoconazole in human plasma: Application to a clinical study of the exposure to ketoconazole in patients after topical administration. A simple, rapid and highly sensitive LC-MS/MS method was developed and validated for the determination of ketoconazole in human plasma. Sample preparation was accomplished through a single step liquid-liquid extraction by ethyl acetate. The chromatography separation was carried out on a Hedera CN (150mm (...) ×2.1mm, 5μm) column with isocratic elution using acetonitrile and 10mM ammonium acetate containing 0.1% formic acid (45:55, v/v) as the mobile phase. The flow rate was 0.5mL/min. Detection was performed in the positive ion electrospray ionization mode using multiple reaction monitoring of the transitions of 531.2→489.3 and 286.1→217.1 for ketoconazole and letrozole (the internal standard), respectively. The method exhibited good linearity over the concentration range of 0.01-12ng/mL for ketoconazole

2017 Journal of pharmaceutical and biomedical analysis Controlled trial quality: uncertain

5. Ketoconazole HRA

Ketoconazole HRA 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact 25 September 2014 EMA/CHMP/534845/2014 Committee for Medicinal Products for Human Use (CHMP) Assessment report Ketoconazole HRA International non-proprietary name: KETOCONAZOLE HRA Procedure No. EMEA/H/C/003906/0000 Note Assessment report as adopted by the CHMP (...) with all information of a commercially confidential nature deleted. Ketoconazole HRA Assessment report EMA/CHMP/534845/2014 Page 2/115 Table of contents 1. Background information on the procedure 5 1.1. Submission of the dossier 5 1.2. Manufacturers 5 1.3. Steps taken for the assessment of the product 6 2. Scientific discussion 6 2.1. Introduction 6 2.2. Quality aspects 10 2.3. Non-clinical aspects 14 2.4. Clinical aspects 22 2.5. Clinical efficacy 31 2.6. Clinical safety 61 2.7. Pharmacovigilance 79

2014 European Medicines Agency - EPARs

6. Effects of Ketoconazole, a CYP4F2 Inhibitor, and CYP4F2*3 Genetic Polymorphism on Pharmacokinetics of Vitamin K (Abstract)

Effects of Ketoconazole, a CYP4F2 Inhibitor, and CYP4F2*3 Genetic Polymorphism on Pharmacokinetics of Vitamin K The objective of this study was to evaluate whether cytochrome P450 (CYP)4F2 is involved in the exposure of vitamin K1 through a drug interaction study with ketoconazole, a CYP4F2 inhibitor, and a pharmacogenetic study with CYP4F2*3. Twenty-one participants with different CYP4F2*3 polymorphisms were enrolled (8 for *1/*1, 7 for *1/*3, and 6 for *3/*3). All participants were treated (...) twice daily for 5 days with 200 mg of ketoconazole or placebo. Finally, a single dose of 10 mg vitamin K1 was administered, plasma levels of vitamin K1 were measured, and its pharmacokinetics was assessed. Ketoconazole elevated the plasma levels of vitamin K1 and increased the average area under the concentration-time curve (AUCinf ) and peak concentration by 41% and 40%, respectively. CYP4F2*3 polymorphism also affected plasma levels of vitamin K1 and its pharmacokinetics in a gene dose-dependent

2019 Journal of clinical pharmacology Controlled trial quality: uncertain

7. The effect of ketoconazole on praziquantel pharmacokinetics and the role of CYP3A4 in the formation of X-OH-praziquantel and not 4-OH-praziquantel. (Abstract)

The effect of ketoconazole on praziquantel pharmacokinetics and the role of CYP3A4 in the formation of X-OH-praziquantel and not 4-OH-praziquantel. The study sought to determine the effect of ketoconazole (KTZ) on the pharmacokinetics of praziquantel (PZQ) and on the formation of its major hydroxylated metabolites, cis- and trans-4-OH-PZQ, and X-OH-PZQ in healthy subjects.Two treatments were evaluated by single-dose PK studies; the reference treatment was a 20 mg/kg dose of praziquantel given (...) alone. The test treatment was a 20 mg/kg dose of praziquantel given in combination with 200 mg of ketoconazole. The study had a balanced and randomised cross-over design. Serial blood samples were collected between 0 and 12 h after each drug administration. PZQ, and cis- and trans-4-OH-PZQ and X-OH-PZQ concentrations in plasma were determined by LC-MS. A non-compartmental approach was used for pharmacokinetic analysis. Data were analysed using ANOVA and assessment of the 90% confidence interval

2019 European journal of clinical pharmacology Controlled trial quality: uncertain

8. The myrtus communis L. solution versus ketoconazole shampoo in treatment of dandruff: A double blinded randomized clinical trial. (Abstract)

The myrtus communis L. solution versus ketoconazole shampoo in treatment of dandruff: A double blinded randomized clinical trial. To evaluate the efficacy and safety of myrtus communis L. solution in the treatment of dandruff and to compare it with ketoconazole.This double-blind randomised clinical trial was conducted at Shiraz University of Medical Sciences, Shiraz, Iran, from December 2015 to August 2016, and comprised patients with dandruff aged 18-60 years visiting the dermatology out (...) -patient clinic. The subjects were randomised into two equal groups. The treatment group received myrtus communis L. solution and a placebo shampoo, while the control group received ketoconazole shampoo and a placebo solution. The total duration of the study for each subject was one month and subjects in both groups used their respective interventions 8 times during that period. The parameters studied were pruritus, erythema, severity of scaling, and the extent of scalp involvement. All subjects

2018 JPMA. The Journal of the Pakistan Medical Association Controlled trial quality: uncertain

9. The role of ketoconazole in current prostate cancer care. (Abstract)

The role of ketoconazole in current prostate cancer care. Ketoconazole is a nonselective steroid 17α-hydroxylase/17,20 lyase (CYP17A1) inhibitor that has been used, off-label, as a second-line therapy for castration-resistant prostate cancer (CRPC). The drug has shown clinical efficacy without survival benefit. Despite not improving survival, ketoconazole has beneficial characteristics, such as its low cost, a relatively favourable toxicity profile compared with chemotherapy, and its efficacy (...) both before and after chemotherapy. The approval of several new, highly effective treatments, including abiraterone acetate, enzalutamide, and apalutamide, warrants re-evaluation of the role of ketoconazole and other classic agents in achieving the optimal timing and sequencing of available agents to prolong survival and maintain patients' quality of life. In the current CRPC treatment landscape, we believe that ketoconazole can be considered in patients with nonmetastatic CRPC and in those

2018 Nature reviews. Urology

10. Ketoconazole Gel Versus Terconazole Cream for Vaginal Candidiasis

Ketoconazole Gel Versus Terconazole Cream for Vaginal Candidiasis Ketoconazole Gel Versus Terconazole Cream for Vaginal Candidiasis - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Ketoconazole Gel Versus (...) contraceptives ,have diabetes , immune compromised taken antibiotics Diagnosis cause itching or soreness Pain during sexual intercourse Pain or discomfort when urinating and abnormal vaginal discharge Although most vaginal candidiasis is mild, some women can develop severe infections involving redness, swelling, and cracks in the wall of the vagina Condition or disease Intervention/treatment Phase Vaginal Candidiasis Drug: Ketoconazole Drug: Terconazole Phase 3 Study Design Go to Layout table for study

2018 Clinical Trials

11. Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash

Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more (...) . Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03471364 Recruitment Status : Recruiting First Posted : March 20, 2018 Last Update Posted : March 14

2018 Clinical Trials

12. Ketoconazole exacerbates mitophagy to induce apoptosis by downregulating cyclooxygenase-2 in hepatocellular carcinoma. (Abstract)

Ketoconazole exacerbates mitophagy to induce apoptosis by downregulating cyclooxygenase-2 in hepatocellular carcinoma. Hepatocellular carcinoma (HCC) is a common cancer worldwide and remains a major clinical challenge. Ketoconazole, a traditional antifungal agent, has attracted considerable attention as a therapeutic option for cancer treatment. However, its mechanism of action is still not clearly defined. We aimed to evaluate the effect of ketoconazole on HCC and investigate the underlying (...) mechanisms.We examined the antitumor effect of ketoconazole on HCC cells, cell line-derived xenografts, and a patient-derived xenograft (PDX) model. Ketoconazole-induced mitophagy was quantified by immunofluorescence, immunoblotting and transmission electron microscopy analysis. We used mitophagy inhibitors to study the role of mitophagy on HCC cell death induced by ketoconazole. The role of cyclooxygenase-2 (COX-2 [encoded by PTGS2]) on ketoconazole-induced mitophagy was evaluated using gain- and loss

2018 Journal of Hepatology

13. Severe Adverse Reactions Following Ketoconazole, Fluconazole, and Environmental Exposures: A Case Report Full Text available with Trip Pro

Severe Adverse Reactions Following Ketoconazole, Fluconazole, and Environmental Exposures: A Case Report In this case report, we describe a 66-year-old man who developed multiple adverse reactions beginning at age 56 after exposure to several azole antifungal drugs including ketoconazole and fluconazole. He also had a history of more than 40 years exposure to chemicals including pesticides, wood preservatives, fertilizers, and welding chemicals. His reactions involved dehydration (requiring (...) be responsible for his increased sensitivity to chemicals following exposure to fluconazole/ketoconazole, including inhibition of P450 and other detoxification enzymes, acetaldehyde buildup, and neurogenic sensitization.

2018 Drug Safety - Case Reports

14. Effects of Ketoconazole and Rifampicin on the Pharmacokinetics of Nintedanib in Healthy Subjects Full Text available with Trip Pro

Effects of Ketoconazole and Rifampicin on the Pharmacokinetics of Nintedanib in Healthy Subjects Nintedanib is a substrate for p-glycoprotein which can impact bioavailability. We investigated the effects of ketoconazole, a p-glycoprotein inhibitor, and rifampicin, a p-glycoprotein inducer, on the pharmacokinetics of nintedanib.In the ketoconazole study, 34 healthy subjects received nintedanib 50 mg orally alone and 1 h after the last dose of ketoconazole given orally at a dose of 400 mg once (...) daily for 3 days in 1 of 2 randomized sequences. In the rifampicin study, 26 subjects received nintedanib 150 mg orally alone and the morning after the last dose of rifampicin given orally at a dose of 600 mg once daily for 7 days. The primary objective was to determine the relative bioavailability of nintedanib administered following multiple doses of ketoconazole or rifampicin versus alone, based on AUC from time 0 extrapolated to infinity (AUC0-∞) and maximum concentration (Cmax) calculated using

2018 European journal of drug metabolism and pharmacokinetics Controlled trial quality: uncertain

15. Investigation of anti-leishmanial efficacy of miltefosine and ketoconazole loaded on nanoniosomes. (Abstract)

Investigation of anti-leishmanial efficacy of miltefosine and ketoconazole loaded on nanoniosomes. Leishmaniasis is a group of parasitic disease caused by protozoa of Leishmania genus. Leishmania major accounts for the cutaneous leishmaniasis (CL). The current treatments of this disease are expensive with high toxicity and are associated to difficulties of healing and parasite resistance. Miltefosine and ketoconazole have been found to be effective against CL. In this study, miltefosine (...) - and ketoconazole-loaded nanoniosomes were prepared by the thin film-hydration method, and their anti-leishmanial effects against Leishmania major promastigotes and amastigotes were evaluated. The particle size and zeta potential of the nanoniosomes were determined. Release from the formulations showed enhanced and controlled dissolution of the drugs. The miltefosine- and ketoconazole-loaded nanoniosomes inhibited the growth of promastigote and amastigote forms of Leishmania major in vitro after 48 h

2018 Acta Tropica

16. HEPATIC SAFETY OF KETOCONAZOLE IN CUSHING'S SYNDROME: RESULTS OF A COMPASSIONATE USE PROGRAM IN FRANCE. Full Text available with Trip Pro

HEPATIC SAFETY OF KETOCONAZOLE IN CUSHING'S SYNDROME: RESULTS OF A COMPASSIONATE USE PROGRAM IN FRANCE. Ketoconazole (KTZ) is one of few available treatments for Cushing's syndrome (CS). Although KTZ has been associated with severe hepatotoxicity, little information is available about hepatic safety in CS. The aim of this study was to document changes in liver function in patients with CS treated with KTZ.An observational prospective French cohort study (Compassionate Use Programme (CUP (...) )).Enrolled patients were stratified into a KTZ-naive cohort and a cohort already treated by another formulation of ketoconazole (KTZ-switch cohort). Liver function markers (alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase, γ-glutamyltransferase and bilirubin) were monitored at regular intervals. Patients with ALT > 3 × ULN (upper limit of normal), total bilirubin > 2 × ULN or both ALP > 2 × ULN and ALT > ULN were considered to have liver injury.Overall, 108 patients were

2018 European Journal of Endocrinology

17. Ketoconazole and Posaconazole Selectively Target HK2 Expressing Glioblastoma Cells. Full Text available with Trip Pro

Ketoconazole and Posaconazole Selectively Target HK2 Expressing Glioblastoma Cells. Hexokinase II (HK2) protein expression is elevated in glioblastoma (GBM), and we have shown that HK2 could serve as an effective therapeutic target for GBM. Here, we interrogated compounds that target HK2 effectively and restrict tumor growth in cell lines, patient-derived glioma stem cells (GSCs), and mouse models of GBM.Experimental Design: We performed a screen using a set of 15 drugs that were predicted (...) to inhibit the HK2-associated gene signature. We next determined the EC50 of the compounds by treating glioma cell lines and GSCs. Selected compounds showing significant impact in vitro were used to treat mice and examine their effect on survival and tumor characteristics. The effect of compounds on the metabolic activity in glioma cells was also assessed in vitro.This screen identified the azole class of antifungals as inhibitors of tumor metabolism. Among the compounds tested, ketoconazole

2018 Clinical Cancer Research

18. Should we avoid using ketoconazole in patients with severe Cushing’s syndrome and increased levels of liver enzymes? Full Text available with Trip Pro

Should we avoid using ketoconazole in patients with severe Cushing’s syndrome and increased levels of liver enzymes? We read with interest the paper of Young et al. in which the authors recommend avoiding ketoconazole in the treatment of Cushing’s syndrome when patients display increased liver enzymes (>2-fold the upper limit of normal (ULN)). We found in a small series of patients that We read with interest the paper of Young et al. in which the authors recommend avoiding ketoconazole (...) in the treatment of Cushing’s syndrome when patients display increased liver enzymes (>2-fold the upper limit of normal (ULN)). Although limited, our experience suggests that liver function tests may improve during ketoconazole treatment and that, in a life-threatening situation such as severe Cushing’s syndrome, increased liver enzymes should not preclude ketoconazole prescription.© 2018 European Society of Endocrinology

2018 European Journal of Endocrinology

19. Fluconazole as a Safe and Effective Alternative to Ketoconazole in Controlling Hypercortisolism of Recurrent Cushing’s Disease: A Case Report Full Text available with Trip Pro

Fluconazole as a Safe and Effective Alternative to Ketoconazole in Controlling Hypercortisolism of Recurrent Cushing’s Disease: A Case Report Ketoconazole has long been the first-line medical therapy for controlling hypercortisolism secondary to either pituitary or adrenal pathology. However, it is largely unavailable in most countries. As a result, we have turned to fluconazole as a viable alternative in view of its favourable safety profile.A 50-year-old lady developed recurrent Cushing's (...) disease after being in remission following transsphenoidal surgery (TSS) for a left pituitary microadenoma 16 years ago. The repeat MRI showed a right pituitary microadenoma (1.7 mm × 1.3 mm) for which she underwent a second TSS. However, she continued to have persistent hypercortisolism despite repeated MRIs showing absence of tumour recurrence. She refused bilateral adrenalectomy and external radiotherapy. Ketoconazole was commenced at 200 mg twice daily for disease control but this was hindered

2018 International journal of endocrinology and metabolism

20. The pharmacokinetics of darexaban (YM150), an oral direct factor Xa inhibitor, are not affected by ketoconazole, a strong inhibitor of CYP3A and P-glycoprotein. (Abstract)

The pharmacokinetics of darexaban (YM150), an oral direct factor Xa inhibitor, are not affected by ketoconazole, a strong inhibitor of CYP3A and P-glycoprotein. We investigated the effects of ketoconazole on the pharmacokinetics (PK) of the direct clotting factor Xa inhibitor darexaban (YM150) and its main active metabolite darexaban glucuronide (YM-222714) which almost entirely determines the antithrombotic effect. In this open-label, randomized, two-period crossover study, 26 healthy male (...) volunteers received in one treatment period a single dose of darexaban 60 mg, and in the other treatment period, ketoconazole 400 mg once daily on Days 1-9 with a single dose of darexaban 60 mg on Day 4. Washout between periods was at least 1 week. The geometric mean ratio (90% confidence interval) of darexaban glucuronide (darexaban plus ketoconazole versus darexaban) for AUCinf was 1.11 (1.00, 1.23), and for Cmax 1.18 (1.03, 1.35). Darexaban concentrations remained very low (AUClast ∼196-fold lower

2018 Clinical pharmacology in drug development Controlled trial quality: uncertain

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