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
29 juli 2026 bijgewerkt door: Chiesi Farmaceutici S.p.A.
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
24
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Chiesi Clinical Trial Info
- Telefoonnummer: +39 0521 279 715
- E-mail: Clinicaltrials_info@chiesi.com
Studie Locaties
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Leeds, Verenigd Koninkrijk
- Fortrea Clinical Research Unit (CRU) Limited
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Contact:
- Jonathan Ackroyd
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Sequentiële toewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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Treatment period 1: Single dose administered on Day 1; Treatment period 2: Single dose administered on Day 13
Treatment period 1: Single dose administered on Day 4; Treatment period 2: Single dose administered on Day 16
Treatment period 2: Single dose administered daily from Day 8 to Day 19
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Pharmacokinetics of Dabigatran : AUC0-t
Tijdsspanne: Up to 72 hours after dosing
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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)
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Up to 72 hours after dosing
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Pharmacokinetics of Dabigatran: AUC0-∞
Tijdsspanne: Up to 72 hours after dosing
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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-∞)
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Up to 72 hours after dosing
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Pharmacokinetics of Dabigatran: Cmax
Tijdsspanne: Up to 72 hours after dosing
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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)
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Up to 72 hours after dosing
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Pharmacokinetics of Rosuvastatin :AUC0-t
Tijdsspanne: Up to 96 hours after dosing
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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
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Up to 96 hours after dosing
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Pharmacokinetics of Rosuvastatin : AUC0-∞
Tijdsspanne: Up to 96 hours after dosing
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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-∞)
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Up to 96 hours after dosing
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Pharmacokinetics of Rosuvastatin: Cmax
Tijdsspanne: Up to 96 hours after dosing
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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
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Up to 96 hours after dosing
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Safety and Tolerability : Incidence of adverse events (AE)
Tijdsspanne: From Baseline Day -1 until Day 8 of TP1 and from Day 8 to Day 20 of TP2
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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
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From Baseline Day -1 until Day 8 of TP1 and from Day 8 to Day 20 of TP2
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Safety and Tolerability : change from baseline for laboratory abnormalities
Tijdsspanne: From Baseline Day -1 until Day 8 for TP1, and from Day 8 to Day 20 of TP 2
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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
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Safety and Tolerability: changes from baseline for vital signs - pulse rate
Tijdsspanne: From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2
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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)
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From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2
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Safety and Tolerability: changes from baseline for vital signs - respiratory rate
Tijdsspanne: From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2
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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)
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From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2
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Safety and Tolerability: changes from baseline for vital signs - blood pressure
Tijdsspanne: From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2
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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
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Safety and Tolerability : change from baseline for ECG intervals
Tijdsspanne: From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2
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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
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Safety and Tolerability : change from baseline for ECG HR
Tijdsspanne: From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2
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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)
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From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2
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Additional Pharmacokinetic Parameters : CL/F of dabigatran
Tijdsspanne: From Day 1 to Day 4 for TP1 and from Day 13 to Day 16 for TP2
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total body clearance (CL/F) of dabigatran (free and total) will be analysed with descriptive statistics by TP
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From Day 1 to Day 4 for TP1 and from Day 13 to Day 16 for TP2
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Additional Pharmacokinetic Parameters: CL/F of resuvastatin
Tijdsspanne: From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 for TP2
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total body clearance (CL/F) of rosuvastatin will be analysed with descriptive statistics by TP
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From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 for TP2
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Additional Pharmacokinetic Parameters: Vd/F of dabigatran
Tijdsspanne: From Day 1 to Day 4 for TP1 and from Day 13 to Day 16 for TP2
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Apparent volume of distribution (Vd/F) of dabigatran (free and total) will be analysed with descriptive statistics by TP
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From Day 1 to Day 4 for TP1 and from Day 13 to Day 16 for TP2
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Additional Pharmacokinetic Parameters: Vd/F of rosuvastatin
Tijdsspanne: From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 forTP2
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Apparent volume of distribution (Vd/F) of rosuvastatin will be analysed with descriptive statistics by TP
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From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 forTP2
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Additional Pharmacokinetic Parameters: tmax of dabigatran
Tijdsspanne: From Day 1 to Day 4 for TP1 and from Day 13 to Day 16 for TP2
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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
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From Day 1 to Day 4 for TP1 and from Day 13 to Day 16 for TP2
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Additional Pharmacokinetic Parameters: tmax of rosuvastatin
Tijdsspanne: From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 for TP2
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Difference in median plasma tmax of rosuvastatin between test 2 (rosuvastatin with CHF10196) and reference 2 (rosuvastatin alone) with 90% two-sided CIs
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From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 for TP2
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Jonathan Ackroyd, Fortrea Clinical Research Unit (CRU)
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
27 oktober 2026
Primaire voltooiing (Geschat)
15 december 2028
Studie voltooiing (Geschat)
15 december 2028
Studieregistratiedata
Eerst ingediend
23 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
29 juli 2026
Eerst geplaatst (Werkelijk)
4 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
4 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
29 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Zwavelverbindingen
- Organische chemicaliën
- Pyridines
- Heterocyclische verbindingen, 1-ring
- Heterocyclische verbindingen
- Benzimidazolen
- Heterocyclische verbindingen, 2-ring
- Heterocyclische verbindingen, gefuseerd ring
- Koolwaterstoffen
- Amides
- Pyrimidines
- Koolwaterstoffen, gehalogeneerd
- Sulfonamides
- Sulfonen
- Fluorobenzenes
- Koolwaterstoffen, gefluoreerd
- Dabigatran
- Rosuvastatine Calcium
Andere studie-ID-nummers
- CLI-10196AA1-06
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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