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 de julho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
24
Estágio
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Chiesi Clinical Trial Info
- Número de telefone: +39 0521 279 715
- E-mail: Clinicaltrials_info@chiesi.com
Locais de estudo
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Leeds, Reino Unido
- Fortrea Clinical Research Unit (CRU) Limited
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Contato:
- Jonathan Ackroyd
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pharmacokinetics of Dabigatran : AUC0-t
Prazo: 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-∞
Prazo: 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
Prazo: 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
Prazo: 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-∞
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Safety and Tolerability : Incidence of adverse events (AE)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Jonathan Ackroyd, Fortrea Clinical Research Unit (CRU)
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
27 de outubro de 2026
Conclusão Primária (Estimado)
15 de dezembro de 2028
Conclusão do estudo (Estimado)
15 de dezembro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
23 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de julho de 2026
Primeira postagem (Real)
4 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Compostos de enxofre
- Produtos químicos orgânicos
- Piridinas
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Benzimidazóis
- Compostos heterocíclicos, 2 anel
- Compostos heterocíclicos, anel fundido
- Hidrocarbonetos
- Amidas
- Pirimidinas
- Hidrocarbonetos, halogenados
- Sulfonamidas
- Sulfonas
- Fluorobenzenos
- Hidrocarbonetos, fluorados
- Dabigatrana
- Rosuvastatina Cálcio
Outros números de identificação do estudo
- CLI-10196AA1-06
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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