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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

NCT07744386 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-08-04

No results posted yet for this study

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

DRUG

Dabigatran Etexilate

Treatment period 1: Single dose administered on Day 1; Treatment period 2: Single dose administered on Day 13

DRUG

Rosuvastatin

Treatment period 1: Single dose administered on Day 4; Treatment period 2: Single dose administered on Day 16

DRUG

CHF10196

Treatment period 2: Single dose administered daily from Day 8 to Day 19

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Jonathan Ackroyd · Fortrea Clinical Research Unit (CRU)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2026-10-27
Primary Completion
2028-12-15
Completion
2028-12-15

Countries

  • United Kingdom

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 NCT07744386 on ClinicalTrials.gov