Status:
COMPLETED
Investigation of the Effect of Inhibition of CYP3A4/5 by Itraconazole on the PK of CHF6001 (Tanimilast)
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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....
Eligibility Criteria
Inclusion
- Subject's written informed consent obtained prior to any study-related procedure;
- Healthy male and female subjects aged 18-55 years inclusive;
- 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.
- Body Mass Index (BMI) between 18,0 and 35,0 kg/m2 extremes inclusive;
- Non- or ex-smokers who smoked \< 5 pack years and stopped smoking \> 1 year prior to screening;
- Good physical and mental status
- Vital signs within normal limits
- 12 -lead digitalized Electrocardiogram (12-lead ECG) considered as normal
- Pulmonary function test within normal limits
- 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
- Participation to another clinical trial where investigational drug was received, and last investigations were performed less than 8 weeks prior to screening;
- 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
- Clinically relevant abnormal laboratory values
- Abnormal liver enzymes at screening
- Subjects with history of breathing problems
- Positive HIV1 or HIV2 serology
- Positive results from the Hepatitis serology
- Blood donation or blood loss (equal or more than 450 ml) less than 2 months prior to screening or before the first dosing;
- Positive urine test for cotinine
- Documented history of alcohol abuse within 12 months prior to screening or a positive alcohol breath test
- Documented history of drug abuse within 12 months prior to screening or a positive urine drug screen
- Intake of non-permitted concomitant medications in the predefined period
- Presence of any current infection, or previous infection that resolved less than 7 days prior to screening or before the first dosing;
- Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation used in the trial;
- Known allergy to antifungal medicines;
- Unsuitable veins for repeated venipuncture;
- Heavy caffeine drinker
- For females only: pregnant or lactating women. Serum pregnancy test to be performed at screening and urine pregnancy test to be performed before the first dosing;
- Subjects receiving treatment with any drug known to have a well-defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole) within the previous 3 months before the screening visit
- Subjects using e-cigarettes within 6 months before screening.
- Positive documented COVID-19 test before admission
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04739774
Start Date
February 22 2021
End Date
April 26 2021
Last Update
May 5 2021
Active Locations (1)
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1
SGS Life Sciences - Clinical Pharmacology Unit Antwerpen
Antwerp, Belgium, 2060