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Ketoconazole

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82. Comparison of abiraterone acetate (Abi) versus ketoconazole (Keto) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) refractory to docetaxel (D). (PubMed)

Comparison of abiraterone acetate (Abi) versus ketoconazole (Keto) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) refractory to docetaxel (D).

2013 Journal of Clinical Oncology

83. Spectroscopic Study of the Interactions of Ruthenium-Ketoconazole Complexes of Known Antiparasitic Activity with Human Serum Albumin and Apotransferrin (PubMed)

Spectroscopic Study of the Interactions of Ruthenium-Ketoconazole Complexes of Known Antiparasitic Activity with Human Serum Albumin and Apotransferrin The pharmacological properties of any drug are related to their ability to interact with macromolecular blood components. The interaction of human serum albumin (HSA) and apotransferrin (ATf) with six RuII complexes containing ketoconazole (KTZ), which we have previously reported to be active against Leishmania major and Trypanosoma cruzi, has

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2013 Journal of the Mexican Chemical Society

84. Lomitapide at supratherapeutic plasma levels does not prolong the Qtc interval--results from a TQT study with moxifloxacin and ketoconazole. (PubMed)

Lomitapide at supratherapeutic plasma levels does not prolong the Qtc interval--results from a TQT study with moxifloxacin and ketoconazole. The aim of this study was to assess the effect of high plasma levels of lomitapide and its main metabolite on ECG parameters.In this randomized five-way cross-over thorough QT study, 56 healthy subjects were enrolled. Study treatments were administered orally for 3 days in five separate periods in which subjects were dosed with (1) a single dose of 75 mg (...) lomitapide on Day 1 followed by a single dose of 200 mg on Day 3; (2) ketoconazole 200 mg BID; (3) ketoconazole with a single dose of 75 mg lomitapide on Day 3; (4) a single dose of 400 mg moxifloxacin on Day 3 and (5) placebo.Single doses of 75 and 200 mg lomitapide alone or in combination with ketoconazole caused minor changes in the change-from-baseline QTcI (ΔQTcI), whereas moxifloxacin and ketoconazole caused an increase of ΔQTcI with a peak effect at 1 and 3 hours postdosing, respectively

2013 Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc

85. The effect of ketoconazole on the pharmacokinetics and pharmacodynamics of inhaled fluticasone furoate and vilanterol trifenatate in healthy subjects. (PubMed)

The effect of ketoconazole on the pharmacokinetics and pharmacodynamics of inhaled fluticasone furoate and vilanterol trifenatate in healthy subjects. To investigate the effects of the cytochrome P450 3A4 (CYP3A4) inhibitor ketoconazole on the pharmacokinetics (PK) and pharmacodynamics of fluticasone furoate (FF) and vilanterol trifenatate (VI).Two double-blind, randomized, placebo-controlled, two-way crossover studies in healthy subjects. In study 1, subjects received single doses (...) of ketoconazole (400 mg) or placebo on days 1-6, with a single dose of inhaled VI (25 μg) on day 5. Pharmacodynamic and PK data were obtained up to 48 h following the VI dose. In study 2, subjects received once daily ketoconazole (400 mg) or placebo for 11 days, with FF/VI (200/25 μg) for the final 7 days. Pharmacodynamic and PK data were obtained up to 48 h following the day 11 dose.In study 1, there was no effect of co-administration of ketoconazole and VI on pharmacodynamic or PK parameters. In study 2, co

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2013 British journal of clinical pharmacology

86. Long-term safety of ketoconazole foam, 2% in the treatment of seborrheic dermatitis: results of a phase IV, open-label study. (PubMed)

Long-term safety of ketoconazole foam, 2% in the treatment of seborrheic dermatitis: results of a phase IV, open-label study. Ketoconazole foam, 2%, is approved in the United States for seborrheic dermatitis therapy in immunocompetent patients aged ≥12 years. While short-term trials have demonstrated its safety and efficacy, seborrheic dermatitis often requires long-term treatment.To assess the long-term safety of ketoconazole foam, 2%, twice daily, as required.A 12-month, open-label (...) improved by 2 units from baseline at all study visits; mean ISGA score improved by 1 unit at week 4 and by 2 units at subsequent visits. The foam vehicle was preferred by 67% of subjects.Evaluation of severity was limited to target lesion; no objective measure of adherence.The long-term safety profile of ketoconazole foam, 2%, in subjects with seborrheic dermatitis was favorable and efficacy was maintained.

2013 Journal of drugs in dermatology : JDD

87. Investigation of the effects of ketoconazole on the pharmacokinetics of macitentan, a novel dual endothelin receptor antagonist, in healthy subjects. (PubMed)

Investigation of the effects of ketoconazole on the pharmacokinetics of macitentan, a novel dual endothelin receptor antagonist, in healthy subjects. Macitentan is a potent, orally active, non-peptide antagonist of endothelin receptors with tissue-targeting properties, currently undergoing clinical development for the treatment of pulmonary arterial hypertension. The formation of its active metabolite, ACT-132577, as well as overall elimination of the drug, is catalyzed by the cytochrome P450 (...) (CYP) system, predominantly CYP3A4 and to a lesser extent CYP2C19 isoenzyme. Macitentan is not a substrate of P-glycoprotein. Hepatic uptake is mostly driven by passive diffusion and is not dependent on organic anion-transporting polypeptide transport. This study aimed to investigate the magnitude of a possible effect of a potent CYP3A4 inhibitor, ketoconazole, on the pharmacokinetics of macitentan.In a two-period, randomized, open-label, crossover study, 10 healthy subjects received each

2013 Clinical pharmacokinetics

88. Effects of ketoconazole on the pharmacokinetics of ponatinib in healthy subjects. (PubMed)

Effects of ketoconazole on the pharmacokinetics of ponatinib in healthy subjects. Ponatinib is a BCR-ABL tyrosine kinase inhibitor (TKI) approved for the treatment of chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia in patients resistant or intolerant to prior TKIs. In vitro studies suggested that metabolism of ponatinib is partially mediated by CYP3A4. The effects of CYP3A4 inhibition on the pharmacokinetics of ponatinib and its CYP3A4-mediated (...) metabolite, AP24567, were evaluated in a single-center, randomized, two-period, two-sequence crossover study in healthy volunteers. Subjects (N = 22) received two single doses (orally) of ponatinib 15 mg, once given alone and once coadministered with daily (5 days) ketoconazole 400 mg, a CYP3A4 inhibitor. Ponatinib plus ketoconazole increased ponatinib maximum plasma concentration (C(max)) and area under the concentration-time curve (AUC) compared with ponatinib alone. The estimated mean ratios for AUC0

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2013 Journal of clinical pharmacology

89. The effect of multiple doses of ketoconazole or rifampin on the single- and multiple-dose pharmacokinetics of vorapaxar. (PubMed)

The effect of multiple doses of ketoconazole or rifampin on the single- and multiple-dose pharmacokinetics of vorapaxar. This randomized, open-label, parallel-group study evaluated the effects of multiple-dose ketoconazole or rifampin on the single- and multiple-dose pharmacokinetics of vorapaxar. Healthy subjects randomly received one of the following three treatments (N = 12/group): (1) ketoconazole 400 mg once daily (QD) for 28 days (Days 1-28) and single-dose vorapaxar 20 mg on Day 7 (...) followed by vorapaxar 2.5 mg QD for 21 days (Days 8-28); (2) rifampin 600 mg QD for 28 days (Days 1-28) and single-dose vorapaxar 20 mg on Day 7 followed by vorapaxar 2.5 mg QD for 21 days (Days 8-28); and (3) placebo QD for 28 days (Days 1-28) and single-dose vorapaxar 20 mg on Day 7 followed by vorapaxar 2.5 mg QD for 21 days (Days 8-28). Ketoconazole increased the steady-state vorapaxar AUC(0-24 h) and C(max) by approximately twofold (GMR [90% CI]: 196% [173,222]; 193% [166,223], respectively

2013 Journal of clinical pharmacology

90. Oral ketoconazole: do not prescribe or use for fungal infections?risk of liver injury outweighs benefits

Oral ketoconazole: do not prescribe or use for fungal infections?risk of liver injury outweighs benefits Oral ketoconazole: do not prescribe or use for fungal infections—risk of liver injury outweighs benefits - GOV.UK GOV.UK uses cookies to make the site simpler. or Search Oral ketoconazole: do not prescribe or use for fungal infections—risk of liver injury outweighs benefits Published 11 December 2014 From: Therapeutic area: , Article date: August 2013 Doctors should no longer prescribe oral (...) ketoconazole for fungal infections, and should review patients’ treatment options because of a risk of liver injury. The European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) concluded that although liver injury such as hepatitis is a known side effect of antifungal medicines, the incidence and the seriousness are higher with oral ketoconazole than with other antifungals. Reported cases of hepatotoxicity include hepatitis, cirrhosis, and liver failure with fatal outcomes

2013 MHRA Drug Safety Update

91. Androgen synthesis in the gonadotropin-suppressed human testes can be markedly suppressed by ketoconazole. (PubMed)

Androgen synthesis in the gonadotropin-suppressed human testes can be markedly suppressed by ketoconazole. The concentration of intratesticular testosterone (IT-T) required for human spermatogenesis is unknown because spermatogenesis can persist despite the markedly reduced IT-T concentrations observed with LH suppression. Methods to lower IT-T further are needed to determine the relationship between IT-T and spermatogenesis.The objective of the study was to determine the effect of inhibiting (...) the synthesis and metabolism of testosterone (T) on IT-T in gonadotropin-suppressed human testes.Forty normal men participated in a blinded, placebo-controlled, randomized trial at an academic center. INTERVENTION/OUTCOME MEASURES: All men were first administered the GnRH antagonist acyline to suppress LH. Forty-eight hours after acyline administration, subjects were randomly assigned to placebo, ketoconazole (to inhibit T synthesis) at 400 or 800 mg, dutasteride (to inhibit T metabolism) 2.5 mg

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2013 The Journal of clinical endocrinology and metabolism

92. The effect of ketoconazole on whole blood and skin ciclosporin concentrations in dogs. (PubMed)

The effect of ketoconazole on whole blood and skin ciclosporin concentrations in dogs. Ciclosporin (CSA) is approved for the treatment of canine atopic dermatitis. Ciclosporin is metabolized by liver cytochrome P450 enzymes, a process inhibited by ketoconazole (KTZ).The aims of this study were to determine skin and blood CSA concentrations when CSA was administered alone at 5.0 (Treatment 1) or 2.5 mg/kg (Treatment 2) and when CSA was administered at 2.5 mg/kg concurrently with KTZ at 5

2013 Veterinary dermatology

93. A Phase I, open-label, randomized, crossover study in three parallel groups to evaluate the effect of Rifampicin, Ketoconazole, and Omeprazole on the pharmacokinetics of THC/CBD oromucosal spray in healthy volunteers. (PubMed)

A Phase I, open-label, randomized, crossover study in three parallel groups to evaluate the effect of Rifampicin, Ketoconazole, and Omeprazole on the pharmacokinetics of THC/CBD oromucosal spray in healthy volunteers. This Phase I study aimed to assess the potential drug-drug interactions (pharmacokinetic [PK] and safety profile) of Δ9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray (Sativex (®), nabiximols) in combination with cytochrome P450 (CYP450) inducer (rifampicin (...) ) or inhibitors (ketoconazole or omeprazole). Thirty-six healthy male subjects were divided into three groups of 12, and then randomized to one of two treatment sequences per group. Subjects received four sprays of THC/CBD (10.8/10 mg) alongside single doses of the CYP3A and 2C19 inducer rifampicin (600 mg), CYP3A inhibitor ketoconazole (400 mg) or CYP2C19 inhibitor omeprazole (40 mg). Plasma samples were analyzed for CBD, THC and its metabolite 11-hydroxy-THC (11-OH-THC). A single dose of four sprays of THC

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2013 SpringerPlus

94. Efficiency of terbinafine 1% cream in comparison with ketoconazole 2% cream and placebo in patients with facial seborrheic dermatitis. (PubMed)

Efficiency of terbinafine 1% cream in comparison with ketoconazole 2% cream and placebo in patients with facial seborrheic dermatitis. Objective: Different medicines have been used to treat seborrheic dermatitis but efficiency of most of them has not been confirmed. This study compared the efficiency of terbinafine 1% cream in comparison with ketoconazole 2% cream and placebo in patients with facial seborrheic dermatitis. Methods: Ninety patients were randomly divided into three groups (...) (there were 30 persons in each group). The patients consumed one of the medicines twice a day and for 4 weeks. The scores were recorded at the trial beginning, and in the 4th and 12th weeks. Demographic features and disease severity of all three groups were normal at the beginning of the study. Results: Mean of total score in terbinafine, ketoconazole and placebo groups was decreased from 5.04 ± 2.02, 5.04 ± 1.50 and 4.97 ± 1.71 at the beginning of the study to 1.78 ± 2.47, 1.81 ± 2.43 and 3.73 ± 1.74

2013 Journal of Dermatological Treatment

95. Efficacy of docetaxel-based chemotherapy following ketoconazole in metastatic castration-resistant prostate cancer: Implications for prior therapy in clinical trials.

Efficacy of docetaxel-based chemotherapy following ketoconazole in metastatic castration-resistant prostate cancer: Implications for prior therapy in clinical trials. Abiraterone acetate (AA) is a CYP17 inhibitor of androgen synthesis approved for use following docetaxel for metastatic castration-resistant prostate cancer (mCRPC); evaluation in the pre-docetaxel setting is ongoing. Given that the reported efficacy of AA is lower following docetaxel vs. pre-docetaxel, the potential exists (...) for cross resistance given docetaxel's partly androgen receptor targeting activity. The efficacy of docetaxel following ketoconazole (KC), a weaker and nonspecific inhibitor of CYP17, may provide some insights into this potential interaction. We retrospectively evaluated the efficacy of every 3-week docetaxel with prednisone (DP) in mCRPC previously exposed to KC compared to KC-naive patients.A randomized phase II trial of men with mCRPC treated with DP + AT-101 (bcl-2 inhibitor) vs. DP plus placebo

2013 Urologic oncology

96. Eribulin mesylate pharmacokinetics in patients with solid tumors receiving repeated oral ketoconazole.

Eribulin mesylate pharmacokinetics in patients with solid tumors receiving repeated oral ketoconazole. Purpose To study the influence of repeated oral administration of ketoconazole, a potent CYP3A4 inhibitor, on the plasma pharmacokinetics of eribulin mesylate administered by single-dose intravenous infusion. Eribulin mesylate is a non-taxane microtubule dynamics inhibitor that is currently under development in phase I-III trials for the treatment of solid tumors. Experimental design (...) A randomized, open-label, two treatments, two sequences, crossover phase I study was performed in patients with advanced solid tumors. Treatments were given on day 1 and day 15 and consisted of 1.4 mg/m(2) eribulin mesylate alone or 0.7 mg/m(2) eribulin mesylate plus 200 mg ketoconazole on the day of eribulin mesylate administration and the following day. Pharmacokinetic sampling for determination of eribulin plasma concentration was performed up to 144 h following administration of eribulin mesylate. Also

2013 Investigational new drugs

97. Effect of the CYP3A inhibitor ketoconazole on the PXR-mediated induction of CYP3A activity.

Effect of the CYP3A inhibitor ketoconazole on the PXR-mediated induction of CYP3A activity. The aim of this clinical study was to investigate a previously proposed mechanism of ketoconazole-mediated inhibition of cytochrome P450 3A (CYP3A) induction.A two-phase, randomized, cross-over, open, mono-centre trial was carried out. Participants received ketoconazole and St John's wort for 8 days to study the proposed suppression of St John's wort-mediated induction of CYP3A at the transcriptional (...) level. In the second phase, we studied the inhibitory effect of a single dose of ketoconazole directly at the enzyme level during CYP3A induction by St John's wort. Midazolam served as a marker substance of CYP3A activity using an established limited sampling strategy.After 8 days of simultaneous ketoconazole and St John's wort administration, CYP3A-mediated midazolam metabolism was strongly inhibited (81 % decrease in clearance). Following the induction of CYP3A with St John's wort (6.6-fold

2013 European journal of clinical pharmacology

98. Treatment of seborrheic dermatitis, Comparison of sertaconazole 2 % cream vs. ketoconazole 2% cream. (PubMed)

Treatment of seborrheic dermatitis, Comparison of sertaconazole 2 % cream vs. ketoconazole 2% cream. Objective: There are controversies in the treatment of seborrheic dermatitis. The aim of this study was to compare the efficacy of sertaconazole 2% cream as against ketoconazole 2% cream in the treatment of seborrheic dermatitis. Methods: A total of 132 patients, who had been diagnosed of seborrheic dermatitis were studied. The first group received sertaconazole 2% cream (group A), and the other (...) received ketoconazole 2% cream (group B). At the beginning of referring and also 2 and 4 weeks after first visit, the patients were examined by a dermatologist to control improvement of clinical symptoms and drug side effects. Results: The mean age of sertaconazole and ketoconazole group was 30.18 ± 12.36 and 34.68 ± 10.16, respectively. Patients with moderate Scoring Index (SI) had the most frequency (76.6%) at pretreatment stage with ketoconazole 2% cream. This is when patients with mild SI had

2013 Journal of Dermatological Treatment

99. The Effect of Gemfibrozil, Ketoconazole and Clarithromycin on the Amount of LY2409021 in the Bloodstream

The Effect of Gemfibrozil, Ketoconazole and Clarithromycin on the Amount of LY2409021 in the Bloodstream The Effect of Gemfibrozil, Ketoconazole and Clarithromycin on the Amount of LY2409021 in the Bloodstream - 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. The Effect of Gemfibrozil, Ketoconazole and Clarithromycin on the Amount of LY2409021 in the Bloodstream 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. Read our for details. ClinicalTrials.gov Identifier: NCT01836198 Recruitment Status : Completed First Posted : April 19, 2013 Results First Posted

2013 Clinical Trials

100. Drug-drug Interaction Trial of BI 113608 in Combination With Ketoconazole and Voriconazole in Healthy Male Subjects

Drug-drug Interaction Trial of BI 113608 in Combination With Ketoconazole and Voriconazole in Healthy Male Subjects Drug-drug Interaction Trial of BI 113608 in Combination With Ketoconazole and Voriconazole in Healthy Male Subjects - 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. Drug-drug Interaction Trial of BI 113608 in Combination With Ketoconazole and Voriconazole in Healthy Male Subjects 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. Read our for details. ClinicalTrials.gov Identifier: NCT01787032 Recruitment Status : Completed First Posted

2013 Clinical Trials

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