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A Study in Healthy Male Participants to Compare How CHF10196 Affects How the Body Absorbs and Processes Two Commonly Used Medicines: Dabigatran, a Blood Thinner, and Rosuvastatin, a Medicine Used to Lower Cholesterol
Sponsor: Chiesi Farmaceutici S.p.A.
Summary
The purpose of this study is to assess the potential drug-drug interaction of CHF10196 (a dipeptidyl peptidase 1 inhibitor) and its metabolite on the pharmacokinetics of dabigatran (a P-glycoprotein substrate) and Rosuvastatin (a breast cancer resistant protein substrate) in healthy male participants.
Official title: An Open-label, Fixed-sequence, Non-randomized, Drug-drug Interaction Study to Evaluate the Effect of CHF10196 on the Pharmacokinetics of Dabigatran (P-gp Substrate) and Rosuvastatin (BCRP Substrate) in Healthy Male Participants.
Key Details
Gender
MALE
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-10-27
Completion Date
2028-12-15
Last Updated
2026-08-04
Healthy Volunteers
Yes
Conditions
Interventions
Dabigatran Etexilate
Treatment period 1: Single dose administered on Day 1; Treatment period 2: Single dose administered on Day 13
Rosuvastatin
Treatment period 1: Single dose administered on Day 4; Treatment period 2: Single dose administered on Day 16
CHF10196
Treatment period 2: Single dose administered daily from Day 8 to Day 19
Locations (1)
Fortrea Clinical Research Unit (CRU) Limited
Leeds, United Kingdom