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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Male Volunteers
• Intervention / Treatment: Drug: Dabigatran Etexilate; Drug: Rosuvastatin; Drug: CHF10196

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Chiesi Clinical Trial Info; Phone Number: +39 0521 279 715; Email: Clinicaltrials_info@chiesi.com

Study Locations

• United Kingdom
  • Leeds, United Kingdom
    • Fortrea Clinical Research Unit (CRU) Limited
    • Contact: Jonathan Ackroyd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fixed-Sequence treatment; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability : Incidence of adverse events (AE)	Number and percentage of study participants by treatment with AEs, adverse events of special interest(AESIs),treatment emergent adverse event(TEAEs), adverse drug reaction(ADRs), non-serious TEAEs, serious TEAEs, serious ADRs, severe TEAEs, TEAEs leading to study discontinuation and to death	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	Clinical laboratory abnormalities, based on haematology and blood chemistry test results by treatment period (TP). Number of participants with abnormal blood laboratory test results. Quantitative laboratory parameters (chemistry and haematology) will be summarised by treatment as absolute value and change from baseline using descriptive statistics	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	Mean changes from baseline to each post-dose timepoint in vital signs PR (pulse rate) by TP Baselines (the last value before the first administration of dabigatran etexilate of each TP or CHF10196 (TP2 only). In TP2, two separate baselines will be derived relative to dabigatran and CHF10196)	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	Mean changes from baseline to each post-dose timepoint in vital signs RR (respiratory rate) by TP Baselines (the last value before the first administration of dabigatran etexilate of each TP or CHF10196 (TP2 only). In TP2, two separate baselines will be derived relative to dabigatran and CHF10196)	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	Mean changes from baseline to each post-dose timepoint in vital signs systolic blood pressure (SBP) and diastolic blood pressure (DBP) by TP. Baselines (the last value before the first administration of dabigatran etexilate of each TP or CHF10196 (TP2 only). In TP2, two separate baselines will be derived relative to dabigatran and CHF10196)	From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2
Safety and Tolerability : change from baseline for ECG intervals	Mean changes from baseline to each post-dose timepoint in 12-lead bedside ECG parameters. Intervals recorded: RR, PR, QT, QTc (Corrected QT interval), and QTcF (Fridericia corrected QT interval), and QRS duration by TP. Baselines (the last value before the first administration of dabigatran etexilate of each TP or CHF10196 (TP2 only). In TP2, two separate baselines will be derived relative to dabigatran and CHF10196)	From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2
Safety and Tolerability : change from baseline for ECG HR	Mean changes from baseline to each post-dose timepoint in 12-lead bedside ECG recording of Heart Rate (HR). Baselines (the last value before the first administration of dabigatran etexilate of each TP or CHF10196 (TP2 only). In TP2, two separate baselines will be derived relative to dabigatran and CHF10196)	From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2
Additional Pharmacokinetic Parameters : CL/F of dabigatran	total body clearance (CL/F) of dabigatran (free and total) will be analysed with descriptive statistics by TP	From Day 1 to Day 4 for TP1 and from Day 13 to Day 16 for TP2
Additional Pharmacokinetic Parameters: CL/F of resuvastatin	total body clearance (CL/F) of rosuvastatin will be analysed with descriptive statistics by TP	From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 for TP2
Additional Pharmacokinetic Parameters: Vd/F of dabigatran	Apparent volume of distribution (Vd/F) of dabigatran (free and total) will be analysed with descriptive statistics by TP	From Day 1 to Day 4 for TP1 and from Day 13 to Day 16 for TP2
Additional Pharmacokinetic Parameters: Vd/F of rosuvastatin	Apparent volume of distribution (Vd/F) of rosuvastatin will be analysed with descriptive statistics by TP	From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 forTP2
Additional Pharmacokinetic Parameters: tmax of dabigatran	Difference in median plasma tmax of dabigatran (free and total) between test 1 (dabigatran [free and total] with CHF10196) and reference 1 (dabigatran [free and total] alone) with 90% two-sided CIs	From Day 1 to Day 4 for TP1 and from Day 13 to Day 16 for TP2
Additional Pharmacokinetic Parameters: tmax of rosuvastatin	Difference in median plasma tmax of rosuvastatin between test 2 (rosuvastatin with CHF10196) and reference 2 (rosuvastatin alone) with 90% two-sided CIs	From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 for TP2

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.
• Investigators: Principal Investigator: Jonathan Ackroyd, Fortrea Clinical Research Unit (CRU)

Study record dates

Study Major Dates

• Study Start (Estimated): October 27, 2026
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): December 15, 2028

Study Registration Dates

• First Submitted: July 23, 2026
• First Submitted That Met QC Criteria: July 29, 2026
• First Posted (Actual): August 4, 2026

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: July 29, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: pharmacokinetics; DDI; CHF10196; Dipeptidyl Peptidase 1 (DPP1) inhibitor
• Additional Relevant MeSH Terms: Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Amides; Pyrimidines; Hydrocarbons, Halogenated; Sulfonamides; Sulfones; Fluorobenzenes; Hydrocarbons, Fluorinated; Dabigatran; Rosuvastatin Calcium
• Other Study ID Numbers: CLI-10196AA1-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No