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

ConditionHealthy Male Volunteers

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexMale

Age18-55

SponsorChiesi Farmaceutici S.p.A.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Use of prohibited concomitant medications

Participation in another clinical study within 3 months

Clinically relevant medical conditions

Abnormal laboratory values

Trial design

Treatments tested in this trial

Dabigatran Etexilate
Rosuvastatin
CHF10196

Treatment groups

24 Participants

are divided into 1 treatment group

Sponsors and collaborators

Chiesi Farmaceutici S.p.A.

Lead sponsor

Source ClinicalTrials.gov