The influence of cytochrome P450 3A4 inhibitors on serum levels of Ivacaftor in cystic fibrosis patients and healthy subjects.

Phase 1

• Conditions: cystic fibrosis and healthy subjects; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2016-001440-18-NL
• Lead Sponsor: university medical center utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-16
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Healthy controls
-Males and females, aged 18 years or older on the date of informed consent
-No medical history
-Signed informed consent form (ICF)

Cystic fibrosis patients
-Males and females, aged 18 years or older on the date of informed consent
-Cystic fibrosis (confirmed by genotype analysis, Class 1 and 2)
-Exocrine pancreatic insufficiency
-Signed informed consent form (ICF)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Use of ivacaftor
-Hepatic impairment defined as (a history of) transaminase elevations
-Severe renal impairment (creatinine clearance = 30 ml/min);
-Use of drugs that are metabolized by the CYP3A enzyme or have a known influence on the CYP3A enzyme (inducers or inhibitors): see appendix.
-Known allergy/intolerance to clarithromycin, ritonavir or azithromycin
-Pregnancy or lactation
-Pregnancy wish
-Pulmonary exacerbation with hospital admission within one month before the study period (defined as need for intravenous antibiotics)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified