Healthy Male VolunteersPhase 1NCT07744386
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
A Phase 1 study testing Dabigatran Etexilate, Rosuvastatin and CHF10196 in people with Healthy Male Volunteers, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- Dabigatran Etexilate, Rosuvastatin and CHF10196
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Oct 2026to 15 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Drug or alcohol abuse
- Use of nicotine-containing products within defined period
- Recent COVID-19 infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Fortrea Clinical Research Unit (CRU) Limited
Leeds
Jonathan Ackroyd
About this study
Official 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.
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
- Being tested
- Dabigatran Etexilate, Rosuvastatin, CHF10196
- Keywords
- pharmacokinetics, CHF10196, DDI, Dipeptidyl Peptidase 1 (DPP1) inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran EtexilateDrug
Treatment period 1: Single dose administered on Day 1; Treatment period 2: Single dose administered on Day 13
RosuvastatinDrug
Treatment period 1: Single dose administered on Day 4; Treatment period 2: Single dose administered on Day 16
CHF10196Drug
Treatment period 2: Single dose administered daily from Day 8 to Day 19
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dabigatran Etexilate; Drug: Rosuvastatin; Drug: CHF10196 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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-∞)
Measured: 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)
Measured: 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
Measured: 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-∞)
Measured: 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
Measured: Up to 96 hours after dosing
Secondary outcomes (13)
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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 for TP2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start27 Oct 2026 (estimated)
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Participants will receive dabigatran and rosuvastatin alone and in combination with CHF10196 at steady-state in two sequential treatment periods.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Ackroyd, Principal investigator, Fortrea Clinical Research Unit (CRU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744386
- Sponsor's protocol ID
- CLI-10196AA1-06
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07744386
- Acronym / sponsor ID
- CLI-10196AA1-06
- Conditions
- Healthy Male Volunteers
- Keywords
- pharmacokinetics, CHF10196, DDI, Dipeptidyl Peptidase 1 (DPP1) inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2026 (estimated)
- Primary completion
- 15 Dec 2028 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will receive dabigatran and rosuvastatin alone and in combination with CHF10196 at steady-state in two sequential treatment periods.
| Arm | Type | Receives |
|---|---|---|
| Fixed-Sequence treatment | Experimental | Drug: Dabigatran Etexilate, Drug: Rosuvastatin, Drug: CHF10196All 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dabigatran EtexilateTreatment period 1: Single dose administered on Day 1; Treatment period 2: Single dose administered on Day 13 | Drug | Fixed-Sequence treatment |
| RosuvastatinTreatment period 1: Single dose administered on Day 4; Treatment period 2: Single dose administered on Day 16 | Drug | Fixed-Sequence treatment |
| CHF10196Treatment period 2: Single dose administered daily from Day 8 to Day 19 | Drug | Fixed-Sequence treatment |
Primary outcome
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)
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-∞)
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)
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
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-∞)
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
13 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No. Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan Ackroyd principal investigator
Fortrea Clinical Research Unit (CRU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dabigatran Etexilate, Rosuvastatin and CHF10196 in people with Healthy Male Volunteers, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiesi Clinical Trial Info (+39 0521 279 715, Clinicaltrials_info@chiesi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of Dabigatran : AUC0-t (time frame: Up to 72 hours after dosing). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.