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NCT06395610Recruiting

Effect of Erythromycin on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers

Open-label, Non-randomised, One-sequence Crossover Study to Investigate the Effect of Inhibition of CYP3A4/5 by Erythromycin on the Pharmacokinetics of CHF6001 in Healthy Subjects
Chiesi Farmaceutici S.p.A.Phase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Chronic Obstructive Pulmonary Disease
Drug/Device/Intervention
CHF6001 DPI
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Chiesi Farmaceutici S.p.A.
Location
Sofia, Bulgaria
Timeline & enrollment
Phase
Phase 1
Start date
Mar 28, 2024
End date
Jul 27, 2024
Enrollment
24 participants
Primary outcome

Pharmacokinetic parameter (AUC0-t),Pharmacokinetic parameter (Cmax)

Summary

The objective of this study is to investigate the effect of the interaction of Erythromycin
 (CYP3A4/5 moderate inhibitor) on the pharmacokinetic of CHF6001 (CYP3A4/5 substrate) in
 Healthy Volunteers.

ICD-10 classifications
Other chronic obstructive pulmonary diseaseChronic obstructive pulmonary disease, unspecifiedOther specified chronic obstructive pulmonary diseaseChronic obstructive pulmonary disease with acute exacerbation, unspecifiedChronic obstructive pulmonary disease with acute lower respiratory infection
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06395610
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06395610 through Pure Global AI's free database. This Phase 1 trial is sponsored by Chiesi Farmaceutici S.p.A. and is currently Recruiting. The study focuses on Chronic Obstructive Pulmonary Disease. Target enrollment is 24 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.