Itraconazole

Generic Name: Itraconazole

Brand Names: Sporanox, Tolsura

Drug Type: Small Molecule

Chemical Formula: C_₃₅H_₃₈Cl_₂N_₈O_₄

CAS Number: 84625-61-6

Unique Ingredient Identifier: 304NUG5GF4

Background: One of the triazole antifungal agents that inhibits cytochrome P-450-dependent enzymes resulting in impairment of ergosterol synthesis. It has been used against histoplasmosis, blastomycosis, cryptococcal meningitis & aspergillosis.

Indication: For the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: pulmonary and extrapulmonary blastomycosis, histoplasmosis, aspergillosis, and onychomycosis.

Associated Conditions: Aspergillosis, Blastomycosis, Chromoblastomycosis, Coccidioidal meningitis, Esophageal Candidiasis, Fungal Infections, Fungal skin infection, Histoplasmosis, Onychomycosis, Oropharyngeal Candidiasis, Paracoccidioidomycosis, Penicillium marneffei infection, Pulmonary coccidioides, Sporotrichosis, Vulvovaginal Candidiasis, Disseminated Other specified protozoal diseases

Associated Therapies: -

Clinical Trials

A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib

Phase 1

Completed

Conditions: Drug-drug Interaction

Interventions: Drug: tucatinib
Drug: repaglinide
Drug: itraconazole
Drug: rifampin
Drug: gemfibrozil
Drug: digoxin
Drug: tolbutamide
Drug: midazolam

First Posted Date: 2018-10-29

Last Posted Date: 2019-12-18

Lead Sponsor: Seagen Inc.

Target Recruit Count: 116

Registration Number: NCT03723395

Locations: 🇺🇸
Covance Clinical Research Unit, Dallas, Texas, United States

A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 894416 in the Blood

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Itraconazole
Drug: BI 894416

First Posted Date: 2018-10-26

Last Posted Date: 2023-08-14

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 14

Registration Number: NCT03722173

Locations: 🇩🇪
Humanpharmakologisches Zentrum Biberach, Biberach, Germany

Chronic Pulmonary Aspergillosis and Ambisome Aerosol With Itraconazole

Phase 3

Recruiting

Conditions: Chronic Pulmonary Aspergillosis

Interventions: Drug: inhaled placebo
Drug: inhaled Ambisome®
Drug: Itraconazole

First Posted Date: 2018-09-04

Last Posted Date: 2023-12-06

Lead Sponsor: Poitiers University Hospital

Target Recruit Count: 224

Registration Number: NCT03656081

Locations: 🇫🇷
CHU Poitiers, Poitiers, France

Drug-drug Interaction Study of Ozanimod With Inhibitor or Inducer of CYP2C8 and/or CYP3A

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: Ozanimod
Drug: Gemfibrozil
Drug: Itraconazole
Drug: Rifampin

First Posted Date: 2018-08-10

Last Posted Date: 2019-05-30

Lead Sponsor: Celgene

Target Recruit Count: 100

Registration Number: NCT03624959

Locations: 🇺🇸
PPD Phase 1 Clinic, Austin, Texas, United States

Pharmacokinetics (PK) Drug Interaction Study of Milademetan and Itraconazole or Posaconazole in Healthy Participants

Early Phase 1

Completed

Conditions: Pharmacokinetics

Interventions: Drug: Milademetan
Drug: Posaconazole
Drug: Itraconazole

First Posted Date: 2018-08-03

Last Posted Date: 2019-02-12

Lead Sponsor: Daiichi Sankyo

Target Recruit Count: 36

Registration Number: NCT03614455

Locations: 🇺🇸
Covance Clinical Research Unit, Inc., Dallas, Texas, United States

A Study to Investigate the Effect of Itraconazole on the PK of Multiple Doses of Balovaptan in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Balovaptan
Drug: Itraconazole

First Posted Date: 2018-07-09

Last Posted Date: 2019-11-04

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 15

Registration Number: NCT03579719

Locations: 🇳🇱
Pra International Group B.V, Groningen, Netherlands

Food-effect, Drug-Drug Interaction (DDI), and Formulation Bridging Study

Phase 1

Completed

Conditions: Inflammatory Bowel Disease

Interventions: Drug: TD-1473
Drug: Itraconazole

First Posted Date: 2018-06-13

Last Posted Date: 2021-01-14

Lead Sponsor: Theravance Biopharma

Target Recruit Count: 36

Registration Number: NCT03555617

Locations: 🇺🇸
Celerion, Lincoln, Nebraska, United States

A Pharmacokinetic Study of the Effect of Itraconazole Exposure to Orvepitant in Healthy Volunteers

Phase 1

Completed

Conditions: Pharmacokinetic Study in Healthy Male Volunteers

Interventions: Drug: Orvepitant
Drug: Itraconazole

First Posted Date: 2018-05-24

Last Posted Date: 2018-10-11

Lead Sponsor: Nerre Therapeutics Ltd.

Target Recruit Count: 16

Registration Number: NCT03535662

Locations: 🇬🇧
Parexel Epcu, Harrow, Middlesex, United Kingdom

Drug-drug Interaction Between Belumosudil, Itraconazole, Rifampicin, Rabeprazole, and Omeprazole in Healthy Volunteers

Phase 1

Completed

Conditions: Drug-drug Interaction
Autoimmune Diseases
Fibrotic Disease

Interventions: Drug: Belumosudil
Drug: Itraconazole
Drug: Rabeprazole
Drug: Rifampicin
Drug: Omeprazole

First Posted Date: 2018-05-21

Last Posted Date: 2022-05-25

Lead Sponsor: Kadmon Corporation, LLC

Target Recruit Count: 73

Registration Number: NCT03530995

Locations: 🇬🇧
Quotient Sciences Ltd, Ruddington, Nottingham, United Kingdom

A Study in Healthy Male Volunteers to Look at How the Test Medicine GLPG1690 is Taken up by the Body When Doses of Itraconazole and Voriconazole Are Given to Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: GLPG1690
Drug: Itraconazole
Drug: Voriconazole

First Posted Date: 2018-05-03

Last Posted Date: 2018-06-11

Lead Sponsor: Galapagos NV

Target Recruit Count: 18

Registration Number: NCT03515382

Locations: 🇬🇧
Quotient Sciences Limited, Ruddington, United Kingdom

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