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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 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

24

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Regno Unito
      • Leeds, Regno Unito
        • Fortrea Clinical Research Unit (CRU) Limited
        • Contatto:
          • Jonathan Ackroyd

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: Dabigatran Etexilate
Treatment period 1: Single dose administered on Day 1; Treatment period 2: Single dose administered on Day 13
Droga: Rosuvastatin
Treatment period 1: Single dose administered on Day 4; Treatment period 2: Single dose administered on Day 16
Droga: CHF10196
Treatment period 2: Single dose administered daily from Day 8 to Day 19

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pharmacokinetics of Dabigatran : AUC0-t
Lasso di tempo: 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-∞
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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-∞
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Safety and Tolerability : Incidence of adverse events (AE)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Chiesi Farmaceutici S.p.A.

Investigatori

  • Investigatore principale: Jonathan Ackroyd, Fortrea Clinical Research Unit (CRU)

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

27 ottobre 2026

Completamento primario (Stimato)

15 dicembre 2028

Completamento dello studio (Stimato)

15 dicembre 2028

Date di iscrizione allo studio

Primo inviato

23 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 luglio 2026

Primo Inserito (Effettivo)

4 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CLI-10196AA1-06

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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