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Investigation of the Effect of Inhibition of CYP3A4/5 by Itraconazole on the PK of CHF6001 (Tanimilast) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Investigation of the Effect of Inhibition of CYP3A4/5 by Itraconazole on the PK of CHF6001 (Tanimilast)

Open-label, Non-randomized, One Sequence Cross-over Study to Investigate the Effect of Inhibition of CYP3A4/5 by Itraconazole on the Pharmacokinetics of CHF6001 in Healthy Subjects

NCT04739774•Chiesi Farmaceutici S.p.A.

View on ClinicalTrials.gov

Summary

The objective of this proposed study is to investigate the pharmacokinetics interaction between CHF6001 as substrate and Itraconazole as inhibitor of CYP3A4/5 in a drug-drug interaction study.

Detailed Description

This clinical trial is a single centre, single dose Phase I study, with a non-randomized, open label, one sequence cross-over design. A total of 24 healthy male and female are planned to be included. Participants will be dosed with CHF6001 before and during co-administration of Itraconazole and will act as their own control. The study will be run with a one-sequence crossover design, where all subjects will be treated with CHF6001 in the first treatment period and CHF6001+Itraconazole in the second treatment period in order to avoid the need of a very long washout from the CYP3A4/5 inhibitor. Standard safety assessments will be conducted during the Study, including safety blood and urine laboratory tests, vital signs, physical examinations, ECGs and observations of any adverse events. Blood samples will be also collected for PK analysis.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subject's written informed consent obtained prior to any study-related procedure;
•2. Healthy male and female subjects aged 18-55 years inclusive;
•3. Ability to understand the study procedures, the risks involved and ability to be trained to use the inhalers correctly and to generate sufficient PIF using the In-Check device.
•4. Body Mass Index (BMI) between 18,0 and 35,0 kg/m2 extremes inclusive;
•5. Non- or ex-smokers who smoked \< 5 pack years and stopped smoking \> 1 year prior to screening;
•6. Good physical and mental status
•7. Vital signs within normal limits
•8. 12 -lead digitalized Electrocardiogram (12-lead ECG) considered as normal
•9. Pulmonary function test within normal limits
•10. Women of Childbearing Potential (WOCBP) with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method in addition to a barrier contraception method from the signature of the informed consent and until the follow-up visit. Males with non-pregnant WOCBP partners: they and or/ their partner must be willing to use a highly effective birth control method in addition to the male condom from the signature of the informed consent and until the follow-up visit. Males with pregnant WOCBP partner: they must be willing to use male contraception (condom) from the signature of the informed consent and until the follow-up visit

Exclusion Criteria

•1. Participation to another clinical trial where investigational drug was received, and last investigations were performed less than 8 weeks prior to screening;
•2. Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders, gastric surgery recent or in the past, and/or impaired gastric motility
•3. Clinically relevant abnormal laboratory values
•4. Abnormal liver enzymes at screening
•5. Subjects with history of breathing problems
•6. Positive HIV1 or HIV2 serology
•7. Positive results from the Hepatitis serology
•8. Blood donation or blood loss (equal or more than 450 ml) less than 2 months prior to screening or before the first dosing;
•9. Positive urine test for cotinine
•10. Documented history of alcohol abuse within 12 months prior to screening or a positive alcohol breath test
+11 more criteria

Locations (1)

SGS Life Sciences - Clinical Pharmacology Unit Antwerpen

Antwerp, Belgium

Key Dates

Start Date

February 22, 2021

Primary Completion Date

April 20, 2021

Completion Date

April 26, 2021

Last Updated

May 5, 2021

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

CHF6001 DPI

DRUG

Itraconazole

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 5, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Investigation of the Effect of Inhibition of CYP3A4/5 by Itraconazole on the PK of CHF6001 (Tanimilast)

Inclusion Criteria

Exclusion Criteria

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