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Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. Drug-Drug Interaction 2 (DDI2) Study

NCT06892756 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-09

No results posted yet for this study

Summary

The main goal of this pharmacokinetic study in healthy volunteers is to evaluate the potential effect of cyclosporine (probe inhibitor of P glycoprotein \[P-gp\] and breast cancer resistance protein \[BCRP\] transporters) on CHF6001 (Tanimilast) systemic exposure following single dose administration, by comparing the area under the curve (AUC) from time 0 to the last quantifiable concentration (AUC0 t) and the maximum plasma concentration (Cmax) of CHF6001 with and without cyclosporine. Participants will receive CHF6001 alone in Treatment Period 1, then CHF6001 after oral cyclosporine in Treatment Period 2, in order to evaluate the cyclosporine drug interaction on CHF6001 systemic exposure. The two treatment periods will be separated by a wash out period of 14 to 17 days.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

CHF6001 dry powder inhaler (DPI)

CHF6001 DPI single dose administration followed by a 14 to 17-day wash-out period before Treatment Period 2

DRUG

Cyclosporine

Oral cyclosporine single dose administration

DRUG

CHF6001 DPI

CHF6001 DPI single dose administration after oral cyclosporine single dose administration

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Maya Dabcheva, MD · MC Comac Medical Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-18
Primary Completion
2025-06-20
Completion
2025-06-20

Countries

  • Bulgaria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06892756 on ClinicalTrials.gov