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 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
24
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Chiesi Clinical Trial Info
- Telefonnummer: +39 0521 279 715
- E-post: Clinicaltrials_info@chiesi.com
Studiesteder
-
-
-
Leeds, Storbritannia
- Fortrea Clinical Research Unit (CRU) Limited
-
Ta kontakt med:
- Jonathan Ackroyd
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pharmacokinetics of Dabigatran : AUC0-t
Tidsramme: 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)
|
Up to 72 hours after dosing
|
|
Pharmacokinetics of Dabigatran: AUC0-∞
Tidsramme: 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-∞)
|
Up to 72 hours after dosing
|
|
Pharmacokinetics of Dabigatran: Cmax
Tidsramme: 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)
|
Up to 72 hours after dosing
|
|
Pharmacokinetics of Rosuvastatin :AUC0-t
Tidsramme: 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
|
Up to 96 hours after dosing
|
|
Pharmacokinetics of Rosuvastatin : AUC0-∞
Tidsramme: 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-∞)
|
Up to 96 hours after dosing
|
|
Pharmacokinetics of Rosuvastatin: Cmax
Tidsramme: 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
|
Up to 96 hours after dosing
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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
|
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
Tidsramme: 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 |
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
Tidsramme: 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)
|
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
Tidsramme: 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)
|
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
Tidsramme: 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) |
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
Tidsramme: 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) |
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
Tidsramme: 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)
|
From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2
|
|
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
|
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
Tidsramme: 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
|
From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 for TP2
|
|
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
|
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
Tidsramme: 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
|
From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 forTP2
|
|
Additional Pharmacokinetic Parameters: tmax of dabigatran
Tidsramme: 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
|
From Day 1 to Day 4 for TP1 and from Day 13 to Day 16 for TP2
|
|
Additional Pharmacokinetic Parameters: tmax of rosuvastatin
Tidsramme: 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
|
From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 for TP2
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Jonathan Ackroyd, Fortrea Clinical Research Unit (CRU)
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
27. oktober 2026
Primær fullføring (Antatt)
15. desember 2028
Studiet fullført (Antatt)
15. desember 2028
Datoer for studieregistrering
Først innsendt
23. juli 2026
Først innsendt som oppfylte QC-kriteriene
29. juli 2026
Først lagt ut (Faktiske)
4. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Svovelforbindelser
- Organiske kjemikalier
- Pyridiner
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Benzimidazoles
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Hydrokarboner
- Amides
- Pyrimidiner
- Hydrokarboner, halogenert
- Sulfonamider
- Sulfoner
- Fluorbenzener
- Hydrokarboner, fluorert
- Dabigatran
- Rosuvastatin kalsium
Andre studie-ID-numre
- CLI-10196AA1-06
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .