A Phase I, Open Interaction Study Between GLPG1837 and Midazolam in Healthy Male Subjects
2015년 10월 21일 업데이트: Galapagos NV
A Phase I, Open Interaction Study Between Oral Doses of GLPG1837 and Single Doses of Midazolam in Healthy Male Subjects
This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG1837 on the single dose pharmacokinetic profile of midazolam administered in fed healthy male subjects. Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions: on Day 1, before dosing with GLPG1837 and on Day 12 co-administered with GLPG1837, after multiple oral doses of GLPG1837 (daily for 10 days, from Day 2 until Day 11).
Also, the safety and tolerability of multiple oral doses of GLPG1837 co-administered with midazolam in healthy male subjects will be evaluated.
A first dose group of 12 subjects will receive a total daily dose of 500 mg (250 mg b.i.d.) GLPG1837 and a second dose group of 12 subjects will receive a total daily dose of 1000 mg (500 mg b.i.d.) GLPG1837.
연구 개요
연구 유형
중재적
등록 (실제)
24
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Antwerp, 벨기에
- SGS LSS Clinical Pharmacology Unit Antwerp
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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
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
남성
설명
Inclusion Criteria:
- healthy male, age 18-50 years
- BMI between 18-30 kg/m2
Exclusion Criteria:
- Any condition that might interfere with the procedures or tests in this study
- Drug or alcohol abuse
- Smoking
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: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Midazolam and 500 mg GLPG1837
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (250 mg b.i.d daily for 10 days) from Days 2 to 11.
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Each subject will receive multiple oral daily doses of GLPG1837 (250 mg b.i.d. for 11 days) from Days 2 to 12.
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).
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실험적: Midazolam and 1000 mg GLPG1837
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (500 mg b.i.d daily for 11 days) from Days 2 to 12.
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Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).
Each subject will receive multiple oral doses of GLPG1837 (500 mg b.i.d. for 11 days) from Days 2 to 12.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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The maximum observed concentration (Cmax) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
기간: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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To characterize the maximum observed concentration (Cmax) of (1'-OH) Midazolam in plasma over time before and after multiple doses of GLPG1837 in healthy male subjects
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Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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The time of occurrence of Cmax (tmax) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
기간: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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To characterize the time of occurrence of Cmax (tmax) of (1'-OH) Midazolam in plasma before and after multiple doses of GLPG1837 in healthy male subjects
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Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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The area under the plasma concentration versus time curve (AUC) of (1'-OH) Midazolam before and after multiple oral doses of GLPG1837
기간: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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To characterize the area under the plasma concentration versus time curve (AUC) of (1'-OH) Midazolam before and after multiple doses of GLPG1837 in healthy male subjects
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Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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The apparent terminal half-life (t1/2) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
기간: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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To characterize the apparent terminal half-life (t1/2) of (1'-OH) Midazolam in plasma before and after multiple doses of GLPG1837 in healthy male subjects
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Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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The maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
기간: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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To characterize the maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
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Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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Number of adverse events
기간: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of the number of adverse events reported
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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Changes in vital signs as measured by heart rate, blood pressure, respiratory rate and oral body temperature
기간: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in vital signs as measured by heart rate, blood pressure, respiratory rate and oral body temperature reported
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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Changes in 12-lead ECG measures
기간: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in 12-ECG measures reported
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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Changes in physical exam measures
기간: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in physical examination reported
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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Changes in blood safety lab parameters
기간: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in blood safety lab parameters reported
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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Changes in urine safety lab parameters
기간: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in urine safety lab parameters reported
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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The time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
기간: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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To characterize the time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
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Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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The area under the plasma concentration versus time curve (AUC) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
기간: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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To characterize the area under the plasma concentration versus time curve (AUC) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
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Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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The apparent terminal half-life (t1/2) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
기간: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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To characterize the apparent terminal half-life (t1/2) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
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Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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The metabolite to GLPG1837 ratios in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
기간: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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To characterize the metabolite to GLPG1837 ratios in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
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Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
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
2015년 9월 1일
기본 완료 (실제)
2015년 10월 1일
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2015년 10월 1일
연구 등록 날짜
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추가 정보
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