Ketoconazole

Generic Name: Ketoconazole

Brand Names: Extina, Ketodan, Ketoderm, Nizoral, Xolegel, Ketoconazole HRA

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₂₈Cl_₂N_₄O_₄

CAS Number: 65277-42-1

Unique Ingredient Identifier: R9400W927I

Background: Ketoconazole is an imidazole antifungal agent used in the prevention and treatment of a variety of fungal infections. It functions by preventing the synthesis of ergosterol, the fungal equivalent of cholesterol, thereby increasing membrane fluidity and preventing growth of the fungus. Ketoconazole was first approved in an oral formulation for systemic use by the FDA in 1981. At this time it was considered a significant improvement over previous antifungals, miconazole and clotrimazole, due to its broad spectrum and good absorption. However, it was discovered that ketoconazole produces frequent gastrointestinal side effects and dose-related hepatitis. These effects combined with waning efficacy led to its eventual replacement by triazole agents, fluconazole, itraconazole, voriconazole, and posaconazole. Ketoconazole and its predecessor clotrimazole continue to be used in topical formulations.

Indication: Ketoconazole is used in the treatment or prevention of fungal infections including blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. In Europe, it is also used in the treatment of endogenous Cushing's syndrome.

Associated Conditions: Bacterial Vaginosis (BV), Blastomycosis, Candidiasis, Systemic, Chromoblastomycosis, Chronic Mucocutaneous Candidiasis (CMC), Coccidioidomycosis, Dandruff, Endogenous Cushing's Syndrome, Fungal Infections, Histoplasmosis, Paracoccidioidomycosis, Seborrheic Dermatitis, Tinea Corporis caused by Epidermophyton floccosumin, Tinea Corporis caused by Trichophyton mentagrophytes, Tinea Corporis caused by Trichophyton rubrum, Tinea Cruris caused by Epidermophyton floccosumin, Tinea Cruris caused by Trichophyton mentagrophytes, Tinea Cruris caused by Trichophyton rubrum, Tinea Pedis caused by Epidermophyton floccosumin, Tinea Pedis caused by Trichophyton mentagrophytes, Tinea Pedis caused by Trichophyton rubrum, Vaginal Candidiasis, Vulvovaginal Candidiasis, Cutaneous candidiasis, Recalcitrant Dermatophytosis, Tinea versicolor caused by Malassezia infection

Associated Therapies: -

Clinical Trials

A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Linifanib (ABT-869)

Phase 1

Completed

Conditions: Solid Tumors

Interventions: Drug: ABT-869
Drug: ketoconazole

First Posted Date: 2010-05-03

Last Posted Date: 2011-07-26

Lead Sponsor: Abbott

Target Recruit Count: 12

Registration Number: NCT01114191

Locations: 🇺🇸
Site Reference ID/Investigator# 35784, Detroit, Michigan, United States
🇺🇸
Site Reference ID/Investigator# 36527, Lebanon, New Hampshire, United States

GSK962040 Drug-drug Interaction Study With Ketoconazole

Phase 1

Completed

Conditions: Gastroparesis

Interventions: Drug: GSK962040
Drug: Ketoconazole

First Posted Date: 2009-12-25

Last Posted Date: 2017-06-20

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 6

Registration Number: NCT01039974

Locations: 🇺🇸
GSK Investigational Site, Buffalo, New York, United States

Ketoconazole and Dexamethasone in Prostate Cancer

Phase 2

Completed

Conditions: Prostate Cancer

Interventions: Drug: Ketoconazole
Drug: Hydrocortisone
Drug: Dexamethasone

First Posted Date: 2009-12-21

Last Posted Date: 2020-06-29

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 32

Registration Number: NCT01036594

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

Phase 1

Completed

Conditions: Lymphoma, Large-Cell, Anaplastic
Disease, Hodgkin
Neoplasms
Carcinomas
Lymphoma, Non-Hodgkin

Interventions: Drug: ketoconazole
Drug: brentuximab vedotin
Drug: rifampin
Drug: midazolam

First Posted Date: 2009-12-04

Last Posted Date: 2014-12-18

Lead Sponsor: Seagen Inc.

Target Recruit Count: 73

Registration Number: NCT01026415

Locations: 🇺🇸
City of Hope, Duarte, California, United States
🇺🇸
Karmanos Cancer Institute / Wayne State University, Detroit, Michigan, United States
🇺🇸
St. Francis Medical Group Oncology & Hematology Specialists, Indianapolis, Indiana, United States

and more 3 locations

A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-263 (Navitoclax).

Phase 1

Completed

Conditions: Lymphoma
Chronic Lymphocytic Leukemia
Solid Tumors

Interventions: Drug: ABT-263
Drug: Ketoconazole

First Posted Date: 2009-11-30

Last Posted Date: 2010-12-20

Lead Sponsor: Abbott

Target Recruit Count: 12

Registration Number: NCT01021358

Locations: 🇺🇸
Site Reference ID/Investigator# 25068, San Antonio, Texas, United States

Drug-Drug Interaction Study Between Colchicine and Ketoconazole

Phase 1

Completed

Conditions: Pharmacokinetics

Interventions: Drug: Ketoconazole
Drug: Colchicine

First Posted Date: 2009-09-24

Last Posted Date: 2009-10-15

Lead Sponsor: Mutual Pharmaceutical Company, Inc.

Target Recruit Count: 24

Registration Number: NCT00983216

Locations: 🇺🇸
PRACS Institute, Ltd. - Cetero Research, Fargo, North Dakota, United States

Phase 0 Microdose Study

Phase 1

Completed

Conditions: Autoimmune Diseases

Interventions: Drug: [14C]-GSK706769
Drug: Ketoconazole

First Posted Date: 2009-09-14

Last Posted Date: 2017-06-27

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 12

Registration Number: NCT00975936

Locations: 🇺🇸
GSK Investigational Site, Madison, Wisconsin, United States

Validation Study of Multiple Probe Compounds for Drug Interaction Evaluation

Phase 1

Completed

Conditions: Drug Interactions

Interventions: Drug: Caffeine
Drug: Ketoconazole
Drug: Rosiglitazone
Drug: Fluconazole
Drug: Flurbiprofen
Drug: Rifampin
Drug: Omeprazole
Drug: Dextromethorphan
Drug: Midazolam
Drug: Rosuvastatin

First Posted Date: 2009-08-24

Last Posted Date: 2018-01-04

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 87

Registration Number: NCT00964106

Locations: 🇰🇷
GSK Investigational Site, Seoul, Korea, Republic of

Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer

Phase 1

Terminated

Conditions: Prostate Cancer

Interventions: Drug: ketoconazole
Drug: hydrocortisone
Drug: dutasteride
Drug: lapatinib

First Posted Date: 2009-08-06

Last Posted Date: 2018-09-04

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 11

Registration Number: NCT00953576

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Study Evaluating The Safety And Tolerability Of Administration Of Single Oral Doses Of SAM-760 To Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: SAM-760
Drug: Placebo of SAM-760
Drug: ketoconazole

First Posted Date: 2009-07-29

Last Posted Date: 2013-02-25

Lead Sponsor: Pfizer

Target Recruit Count: 124

Registration Number: NCT00948662

Locations: 🇫🇷
Pfizer Investigational Site, Rueil Malmaison, France

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