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 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
24
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Chiesi Clinical Trial Info
- Numéro de téléphone: +39 0521 279 715
- E-mail: Clinicaltrials_info@chiesi.com
Lieux d'étude
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Leeds, Royaume-Uni
- Fortrea Clinical Research Unit (CRU) Limited
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Contact:
- Jonathan Ackroyd
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pharmacokinetics of Dabigatran : AUC0-t
Délai: 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-∞
Délai: 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
Délai: 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
Délai: 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-∞
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Safety and Tolerability : Incidence of adverse events (AE)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Jonathan Ackroyd, Fortrea Clinical Research Unit (CRU)
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
27 octobre 2026
Achèvement primaire (Estimé)
15 décembre 2028
Achèvement de l'étude (Estimé)
15 décembre 2028
Dates d'inscription aux études
Première soumission
23 juillet 2026
Première soumission répondant aux critères de contrôle qualité
29 juillet 2026
Première publication (Réel)
4 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Composés de soufre
- Produits chimiques organiques
- Pyridines
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Benzimidazoles
- Composés hétérocycliques, 2 anneaux
- Composés hétérocycliques, anneau fusionné
- Hydrocarbures
- Amides
- Pyrimidines
- Hydrocarbures, halogénés
- Sulfonamides
- Sulfones
- Fluorobenzènes
- Hydrocarbures, fluorés
- Dabigatran
- Rosuvastatine calcique
Autres numéros d'identification d'étude
- CLI-10196AA1-06
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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