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Effect of Erythromycin on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers - Trial NCT06395610

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.

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NCT06395610
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06395610
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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

Study Focus

CHF6001 DPI

Interventional

drug

Sponsor & Location

Chiesi Farmaceutici S.p.A.

Sofia, Bulgaria

Timeline & Enrollment

Phase 1

Mar 28, 2024

Jul 27, 2024

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 disease
Chronic obstructive pulmonary disease, unspecified
Other specified chronic obstructive pulmonary disease
Chronic obstructive pulmonary disease with acute exacerbation, unspecified
Chronic obstructive pulmonary disease with acute lower respiratory infection

Data Source

ClinicalTrials.gov

NCT06395610

Non-Device Trial