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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

2026년 7월 29일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

24

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 영국
      • Leeds, 영국
        • Fortrea Clinical Research Unit (CRU) Limited
        • 연락하다:
          • Jonathan Ackroyd

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

예

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: Dabigatran Etexilate
Treatment period 1: Single dose administered on Day 1; Treatment period 2: Single dose administered on Day 13
의약품: Rosuvastatin
Treatment period 1: Single dose administered on Day 4; Treatment period 2: Single dose administered on Day 16
의약품: CHF10196
Treatment period 2: Single dose administered daily from Day 8 to Day 19

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Pharmacokinetics of Dabigatran : AUC0-t
기간: 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-∞
기간: 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
기간: 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
기간: 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-∞
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Safety and Tolerability : Incidence of adverse events (AE)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Chiesi Farmaceutici S.p.A.

수사관

  • 수석 연구원: Jonathan Ackroyd, Fortrea Clinical Research Unit (CRU)

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 27일

기본 완료 (추정된)

2028년 12월 15일

연구 완료 (추정된)

2028년 12월 15일

연구 등록 날짜

최초 제출

2026년 7월 23일

QC 기준을 충족하는 최초 제출

2026년 7월 29일

처음 게시됨 (실제)

2026년 8월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 29일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CLI-10196AA1-06

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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