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

Study Identifier:
CLI-10196AA1-06
ClinicalTrials.gov Identifier:
NCT07744386
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
+39 0521 279 715 or [email protected]
Will Be Recruiting

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: Dabigatran Etexilate
  • Drug: Rosuvastatin
  • Drug: CHF10196
Date
Oct 2026 - Dec 2028
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Male
Age: 18 - 55 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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
Healthy Volunteers
Yes

Protocol 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.

Study Locations

Location
Status
Location
Fortrea Clinical Research Unit (CRU) Limited
Leeds, United Kingdom
Status
N/A