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

Starting soon · Phase 1

Conditions studied: Healthy Male Volunteers

In brief

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.

Key facts

Study ID

NCT07744386

Run by

Chiesi Farmaceutici S.p.A.

People needed

24

Starts

2026-10-27

Expected to finish

2028-12-15

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Healthy male participants aged 18 to 55 years
• Body mass index between 18.0 and 30.0 kg/m²
• Non-smokers or ex-smokers (<5 pack-years)
• Clinically healthy based on medical history and examination
• Vital signs and ECG within normal limits
• Willing and able to comply with study procedures

You may not qualify if…

• Use of prohibited concomitant medications
• Participation in another clinical study within 3 months
• Clinically relevant medical conditions
• Abnormal laboratory values
• Positive HIV, hepatitis B, or hepatitis C
• History of bleeding disorders
• Drug or alcohol abuse
• Use of nicotine-containing products within defined period
• Recent COVID-19 infection

Where it is running

• Fortrea Clinical Research Unit (CRU) Limited — Leeds, United Kingdom

Full record on ClinicalTrials.gov

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