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NCT Number: NCT07744386

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

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.

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Key information

Conditions

Healthy Male Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit (CRU) Limited

Leeds, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dabigatran Etexilate

Drug

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

Rosuvastatin

Drug

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

CHF10196

Drug

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

Primary outcomes

  1. Pharmacokinetics of Dabigatran : AUC0-t

    Time frame: 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)

  2. Pharmacokinetics of Dabigatran: AUC0-∞

    Time frame: 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-∞)

  3. Pharmacokinetics of Dabigatran: Cmax

    Time frame: 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)

  4. Pharmacokinetics of Rosuvastatin :AUC0-t

    Time frame: 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

  5. Pharmacokinetics of Rosuvastatin : AUC0-∞

    Time frame: 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-∞)

  6. Pharmacokinetics of Rosuvastatin: Cmax

    Time frame: 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

Secondary outcomes

  1. Safety and Tolerability : Incidence of adverse events (AE)

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

    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

  2. Safety and Tolerability : change from baseline for laboratory abnormalities

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

    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

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

    Time frame: From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2

    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)

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

    Time frame: From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2

    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)

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

    Time frame: From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2

    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)

  6. Safety and Tolerability : change from baseline for ECG intervals

    Time frame: From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2

    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)

  7. Safety and Tolerability : change from baseline for ECG HR

    Time frame: From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2

    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)

  8. Additional Pharmacokinetic Parameters : CL/F of dabigatran

    Time frame: From Day 1 to Day 4 for TP1 and from Day 13 to Day 16 for TP2

    total body clearance (CL/F) of dabigatran (free and total) will be analysed with descriptive statistics by TP

  9. Additional Pharmacokinetic Parameters: CL/F of resuvastatin

    Time frame: From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 for TP2

    total body clearance (CL/F) of rosuvastatin will be analysed with descriptive statistics by TP

  10. Additional Pharmacokinetic Parameters: Vd/F of dabigatran

    Time frame: From Day 1 to Day 4 for TP1 and from Day 13 to Day 16 for TP2

    Apparent volume of distribution (Vd/F) of dabigatran (free and total) will be analysed with descriptive statistics by TP

  11. Additional Pharmacokinetic Parameters: Vd/F of rosuvastatin

    Time frame: From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 forTP2

    Apparent volume of distribution (Vd/F) of rosuvastatin will be analysed with descriptive statistics by TP

  12. Additional Pharmacokinetic Parameters: tmax of dabigatran

    Time frame: From Day 1 to Day 4 for TP1 and from Day 13 to Day 16 for TP2

    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

  13. Additional Pharmacokinetic Parameters: tmax of rosuvastatin

    Time frame: From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 for TP2

    Difference in median plasma tmax of rosuvastatin between test 2 (rosuvastatin with CHF10196) and reference 2 (rosuvastatin alone) with 90% two-sided CIs

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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