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
Dabigatran Etexilate: Treatment period 1: Single dose administered on Day 1; Treatment period 2: Single dose administered on Day 13
Rosuvastatin: Treatment period 1: Single dose administered on Day 4; Treatment period 2: Single dose administered on Day 16
CHF10196: Treatment period 2: Single dose administered daily from Day 8 to Day 19
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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Pharmacokinetics of Dabigatran : AUC0-t — Up to 72 hours after dosing comparing the ratios of adjusted geometric means between test 1 (dabigatran \[free and total\] with CHF10196) and reference 1 (dabigatran \[free and total\] alone), with 90% two-sided Confidential Intervals(CI), will be calculated for plasma dabigatran (free and total) area under the plasma concentration-time curve, from time 0 to the last measurable concentration (AUC0-t)
Pharmacokinetics of Dabigatran: AUC0-∞ — Up to 72 hours after dosing comparing the ratios of adjusted geometric means between test 1 (dabigatran \[free and total\] with CHF10196) and reference 1 (dabigatran \[free and total\] alone), with 90% two-sided CIs, will be calculated for plasma dabigatran (free and total) area under the plasma concentration-time curve, from time 0 to the last measurable concentration (AUC0-∞)
Pharmacokinetics of Dabigatran: Cmax — Up to 72 hours after dosing comparing the ratios of adjusted geometric means between test 1 (dabigatran \[free and total\] with CHF10196) and reference 1 (dabigatran \[free and total\] alone), with 90% two-sided CIs, will be calculated for plasma dabigatran (free and total) maximum observed maximum observed concentration (Cmax)
Pharmacokinetics of Rosuvastatin :AUC0-t — Up to 96 hours after dosing The ratios of adjusted geometric means between test 2 (rosuvastatin with CHF10196) and reference 2 (rosuvastatin alone), with 90% two sided CIs, will be calculated for plasma rosuvastatin AUC0-t
Pharmacokinetics of Rosuvastatin : AUC0-∞ — Up to 96 hours after dosing The ratios of adjusted geometric means between test 2 (rosuvastatin with CHF10196) and reference 2 (rosuvastatin alone), with 90% two sided CIs, will be calculated for plasma rosuvastatin (AUC0-∞)
Pharmacokinetics of Rosuvastatin: Cmax — Up to 96 hours after dosing The ratios of adjusted geometric means between test 2 (rosuvastatin with CHF10196) and reference 2 (rosuvastatin alone), with 90% two sided CIs, will be calculated for plasma rosuvastatin Cmax
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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