A Study in Healthy Male Participants to Compare How CHF10196 Affects How the Body Absorbs and Processes Two Commonly Used Medicines: Dabigatran, a... | NCT07744386

NCT07744386

Overview

NCT ID: NCT07744386
Lead Sponsor: Chiesi Farmaceutici S.p.A.INDUSTRY
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.
Brief 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.
Conditions: Healthy Male Volunteers
Interventions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 4, 2026Actual
Start Date: Oct 27, 2026Estimated
Primary Completion Date: Dec 15, 2028Estimated

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers?: Yes
Eligibility 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

Study Plan

Study Type: Interventional
Phase: Phase 1
Enrollment: 24Estimated
Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Sequential Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Chiesi Clinical Trial InfoContact
Clinicaltrials_info@chiesi.com

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