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

Study in Healthy Male Subjects to Evaluate the Effect of Itraconazole and Rifampicin on the PK of Fedovapagon

Phase 1

Completed

Conditions: Nocturia

Interventions: Drug: fedovapagon
Drug: rifampicin
Drug: Itraconazole

First Posted Date: 2015-05-12

Last Posted Date: 2015-07-30

Lead Sponsor: Vantia Ltd

Target Recruit Count: 29

Registration Number: NCT02440841

Locations: 🇩🇪
PAREXEL Early Phase Clinical Unit Berlin, Berlin, Germany

A Randomized Trial of Itraconazole in Acute Stages of Allergic Bronchopulmonary Aspergillosis

Phase 2

Completed

Conditions: Allergic Bronchopulmonary Aspergillosis

Interventions: Drug: Glucocorticoids
Drug: Itraconazole

First Posted Date: 2015-05-12

Last Posted Date: 2022-10-07

Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Target Recruit Count: 191

Registration Number: NCT02440009

Locations: 🇮🇳
Chest Clinic, PGIMER, Chandigarh, India

First-in-human: Single Ascending Dose, Food Effect, Drug-drug Interaction, Multiple Ascending Dose, Proof of Pharmacology

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: ASP6282
Drug: Placebo
Drug: Pilocarpine
Drug: Itraconazole
Drug: Midazolam

First Posted Date: 2015-04-20

Last Posted Date: 2016-07-01

Lead Sponsor: Astellas Pharma Europe B.V.

Target Recruit Count: 116

Registration Number: NCT02420782

Locations: 🇬🇧
Site GB44001, Harrow, United Kingdom
🇩🇪
Site DE49001, Berlin, Germany

Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: AVP-923
Drug: AVP-786
Drug: Itraconazole

First Posted Date: 2015-03-30

Last Posted Date: 2017-03-20

Lead Sponsor: Avanir Pharmaceuticals

Target Recruit Count: 24

Registration Number: NCT02402595

Locations: 🇺🇸
Vince and Associates Clinical Research, Inc., Overland Park, Kansas, United States

ATRA, Celecoxib, and Itraconazole as Maintenance

Phase 1

Completed

Conditions: Relapsed Multiple Myeloma

Interventions: Drug: ATRA
Drug: Celecoxib
Drug: Itraconazole

First Posted Date: 2015-03-27

Last Posted Date: 2017-02-23

Lead Sponsor: University of Iowa

Target Recruit Count: 1

Registration Number: NCT02401295

Locations: 🇺🇸
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

Drug-Drug Interaction Study Between TAK-272 and Itraconazole, Digoxin or Midazolam

Phase 1

Completed

Conditions: Japanese Healthy Adult Males

Interventions: Drug: TAK-272
Drug: Itraconazole
Drug: Digoxin
Drug: Midazolam

First Posted Date: 2015-02-25

Last Posted Date: 2016-05-23

Lead Sponsor: Takeda

Target Recruit Count: 34

Registration Number: NCT02370615

A Study of LY3154207 in Healthy Participants

Phase 1

Completed

Conditions: Healthy Participants

Interventions: Drug: LY3154207
Drug: Placebo
Drug: Itraconazole

First Posted Date: 2015-02-19

Last Posted Date: 2015-06-11

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 64

Registration Number: NCT02365571

Locations: 🇺🇸
PRA Health Sciences, Salt Lake City, Utah, United States

Neoadjuvant Itraconazole in Non-small Cell Lung Cancer

Early Phase 1

Completed

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: Itraconazole

First Posted Date: 2015-02-06

Last Posted Date: 2021-05-03

Lead Sponsor: University of Texas Southwestern Medical Center

Target Recruit Count: 13

Registration Number: NCT02357836

Locations: 🇺🇸
UT Southwestern Medical Center, Dallas, Texas, United States

Relative Bioavailability of a Single Oral Dose of BI 425809 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BI 425809
Drug: Itraconazole

First Posted Date: 2015-01-21

Last Posted Date: 2015-04-03

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 16

Registration Number: NCT02342717

Locations: 🇩🇪
1346.10.1 Boehringer Ingelheim Investigational Site, Biberach, Germany

A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of PF-04958242 in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: PF-04958242
Drug: Itraconazole

First Posted Date: 2015-01-19

Last Posted Date: 2020-01-09

Lead Sponsor: Biogen

Target Recruit Count: 13

Registration Number: NCT02341482

Locations: 🇺🇸
Pfizer New Haven Clinical Research Unit, New Haven, Connecticut, United States

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