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 | Not Yet Recruiting Phase 1

• 1 other identifier: CLI-10196AA1-06
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

pharmacokinetics; CHF10196; DDI; Dipeptidyl Peptidase 1 (DPP1) inhibitor

Outcome Measures

Primary Outcomes (6)

• Pharmacokinetics of Dabigatran : AUC0-t

  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)

  Up to 72 hours after dosing

• Pharmacokinetics of Dabigatran: AUC0-∞

  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-∞)

  Up to 72 hours after dosing

• Pharmacokinetics of Dabigatran: Cmax

  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)

  Up to 72 hours after dosing

• Pharmacokinetics of Rosuvastatin :AUC0-t

  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

  Up to 96 hours after dosing

• Pharmacokinetics of Rosuvastatin : AUC0-∞

  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-∞)

  Up to 96 hours after dosing

• Pharmacokinetics of Rosuvastatin: Cmax

  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

  Up to 96 hours after dosing

Secondary Outcomes (13)

• Safety and Tolerability : Incidence of adverse events (AE)

  From Baseline Day -1 until Day 8 of TP1 and from Day 8 to Day 20 of TP2

• Safety and Tolerability : change from baseline for laboratory abnormalities

  From Baseline Day -1 until Day 8 for TP1, and from Day 8 to Day 20 of TP 2

• Safety and Tolerability: changes from baseline for vital signs - pulse rate

  From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2

• Safety and Tolerability: changes from baseline for vital signs - respiratory rate

  From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2

• Safety and Tolerability: changes from baseline for vital signs - blood pressure

  From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2

Study Arms (1)

Fixed-Sequence treatment

EXPERIMENTAL

All participants will receive dabigatran alone and rosuvastatin alone in Treatment Period 1. During Treatment Period 2, participants will receive CHF10196 alone, with dabigatran, and with rosuvastatin.

Drug: Dabigatran Etexilate; Drug: Rosuvastatin; Drug: CHF10196

Interventions

Dabigatran Etexilate DRUG

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

Fixed-Sequence treatment

Rosuvastatin DRUG

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

Fixed-Sequence treatment

CHF10196 DRUG

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

Fixed-Sequence treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Fortrea Clinical Research Unit (CRU) Limited

Leeds, United Kingdom

Location

MeSH Terms

Interventions

Dabigatran; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Study Officials

• Jonathan Ackroyd

  Fortrea Clinical Research Unit (CRU)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiesi Clinical Trial Info

CONTACT

+39 0521 279 715; Clinicaltrials_info@chiesi.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will receive dabigatran and rosuvastatin alone and in combination with CHF10196 at steady-state in two sequential treatment periods.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): October 27, 2026
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): December 15, 2028
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)