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 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
24
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Chiesi Clinical Trial Info
- Telefonnummer: +39 0521 279 715
- E-mail: Clinicaltrials_info@chiesi.com
Studiesteder
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Leeds, Det Forenede Kongerige
- Fortrea Clinical Research Unit (CRU) Limited
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Kontakt:
- Jonathan Ackroyd
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pharmacokinetics of Dabigatran : AUC0-t
Tidsramme: 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-∞
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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-∞
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Safety and Tolerability : Incidence of adverse events (AE)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jonathan Ackroyd, Fortrea Clinical Research Unit (CRU)
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
27. oktober 2026
Primær færdiggørelse (Anslået)
15. december 2028
Studieafslutning (Anslået)
15. december 2028
Datoer for studieregistrering
Først indsendt
23. juli 2026
Først indsendt, der opfyldte QC-kriterier
29. juli 2026
Først opslået (Faktiske)
4. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Svovlforbindelser
- Organiske kemikalier
- Pyridiner
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Benzimidazoler
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Kulbrinter
- Amider
- Pyrimidiner
- Kulbrinter, halogeneret
- Sulfonamider
- Sulfoner
- Fluorobenzener
- Kulbrinter, fluoreret
- Dabigatran
- Rosuvastatin Calcium
Andre undersøgelses-id-numre
- CLI-10196AA1-06
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website.
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