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

Study Identifier:
CLI-06001AA1-11
ClinicalTrials.gov Identifier:
NCT04739774
EudraCT Identifier:
2020-003769-21
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Chronic Obstructive Pulmonary Disease
Study Drug
  • Drug: CHF6001 DPI
  • Drug: Itraconazole
Date
Feb 2021 - Apr 2021
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 55 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • 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 Criteria
  • 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
Healthy Volunteers
Yes

Protocol 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.

Study Locations

Location
Status
Location
SGS Life Sciences - Clinical Pharmacology Unit Antwerpen
Antwerp, Belgium, 2060
Status
N/A