Human Mass Balance Study of [14C] Ontunisertib in Healthy Volunteers
An Open-label, Two-part Trial to Assess the Mass-balance Recovery, Metabolite Profile, Metabolite Identification and Absolute Bioavailability of [14C] Ontunisertib in Healthy Male Participants
This is an open, two-part study in healthy male volunteers, aged 30-65 years.
This trial aims to understand how the human body absorbs, distributes, metabolizes and eliminates ontunisertib after a single oral dose of radiolabelled test medicine ([14C]ontunisertib) and determine the routes and rates of elimination of the test medicine.
연구 개요
상세 설명
This is an open, two-part study in healthy male volunteers, aged 30-65 years with the trial duration of approximately 7 weeks.
In Part 1 of this study, healthy volunteers will be given a dose of test medicine orally followed by an intravenous injection of a very small dose of radiolabelled test medicine that contains a tiny amount of radioactivity (called carbon-14) so that the test medicine can be traced in the blood.
In Part 2, single doses of test medicine will be administered orally to find out how the body breaks down and gets rid of the test medicine. The test medicine will be 'radiolabelled' - it will contain a small amount of radioactivity (Carbon-14) - so that it can be traced in the body.
Participants will take part in both study parts and will remain resident in the clinic for up to 10 days after their final dose of Investigation Medicinal Product (IMP). After the participants have left the clinic, they may have to collect their urine and faeces at home until mass balance criteria has been met.
Over a period of at least 8 days in Part 1 and 10 days in Part 2, many blood samples will be taken, and volunteers will collect all their urine and faeces so that the amount of test medicine and its breakdown products can be measured/analysed.
A blood sample will be taken from volunteers between admission and first dose for pharmacogenetic testing.
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Agomab Clinical Operations
- 전화번호: 0032 3318 91 70
- 이메일: clinicalstudies@agomab.com
연구 장소
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Nottingham, 영국, NG11 6JS
- 모병
- Quotient Sciences Limited
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Males aged 30 to 65 years inclusive at the time of signing informed consent
- Must agree to the use of an adequate method of contraception for up to 93 days post-final dose
- Healthy male participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead ECG, and laboratory safety tests without any clinically significant abnormalities.
- Body mass index of 18.0 to 29.9 kg/m2
Exclusion Criteria:
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- History of clinically significant renal, hepatic, respiratory, particularly GI disease, especially peptic ulceration, clinically significant GI bleeding, ulcerative colitis, Crohn's Disease or Irritable Bowel Syndrome, and neurological or psychiatric disorder
- History of GI surgery (with the exception of appendectomy or hernia repair unless it was performed within the previous 12 months)
- Clinically significant abnormal clinical chemistry, hematology, coagulation or urinalysis as judged by the investigator at screening.
- Radiation exposure, including that from the present trial, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker shall participate in the trial
- Participants who have been administered IMP in an ADME trial or any trial involving administration of 14C radioactivity in the last 12 months
- Male participants with pregnant or lactating partners
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Ontunisertib
Participants will receive single oral dose of ontunisertib
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Oral capsule
다른 이름들:
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실험적: [14C]ontunisertib solution for infusion
Participants will receive single IV dose of [14C]ontunisertib
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IV infusion
Oral capsule
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실험적: [14C]ontunisertib
Participants will receive single oral dose of [14C]ontunisertib
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IV infusion
Oral capsule
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Absolute bioavailability of ontunisertib following oral and IV administration
기간: Through study completion, an average of 8 days
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Part 1: To determine the absolute oral bioavailability of ontunisertib
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Through study completion, an average of 8 days
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Cumulative amount of total radioactivity excreted in urine and feces
기간: Through study completion, an average of 10 days
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Part 2: To determine the mass balance recovery after a single oral dose of [14C]ontunisertib
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Through study completion, an average of 10 days
|
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Chemical structure of each metabolite accounting for ≥10% of circulating total radioactivity and Metabolite profiling accounting for >80% of total radioactivity recovered in urine and/or feces
기간: Through study completion, an average of 10 days
|
Part 2: To characterize the metabolite profile in plasma and excreta (urine and/or feces) after a single oral dose of [14C]ontunisertib
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Through study completion, an average of 10 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PK parameter (AUClast)
기간: Through study completion, an average of 8 days
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Part 1: To characterize the IV PK (AUClast) of [14C]ontunisertib and total radioactivity in plasma
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Through study completion, an average of 8 days
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Cumulative amount of total radioactivity excreted in urine and feces following IV administration
기간: Through study completion, an average of 8 days
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Part 1: To determine the mass balance recovery after a single IV dose of [14C]ontunisertib
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Through study completion, an average of 8 days
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PK parameter (AUClast)
기간: Through study completion, an average of 18 days
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Part 1 and Part 2: To characterize the plasma PK (AUClast) of ontunisertib and metabolites and total radioactivity (Part 2 only) following a single oral dose
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Through study completion, an average of 18 days
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Whole blood-to-plasma concentration ratios for total radioactivity
기간: Through study completion, an average of 10 days
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Part 2: To evaluate the extent of distribution of total radioactivity into blood cells
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Through study completion, an average of 10 days
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Number of participants with adverse events (AEs)
기간: Through study completion, an average of 18 days
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Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
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Through study completion, an average of 18 days
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Number of participants with abnormal physical examinations
기간: Through study completion, an average of 18 days
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Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
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Through study completion, an average of 18 days
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Number of participants with abnormal vital signs
기간: Through study completion, an average of 18 days
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Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
|
Through study completion, an average of 18 days
|
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Number of participants with abnormal ECGs parameters
기간: Through study completion, an average of 18 days
|
Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
|
Through study completion, an average of 18 days
|
|
Number of participants with abnormal clinical laboratory safety tests
기간: Through study completion, an average of 18 days
|
Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
|
Through study completion, an average of 18 days
|
|
Chemical structure analysis of metabolites accounting for ≥10%
기간: Through study completion, an average of 8 days
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Part 1: To characterize the metabolites profile in plasma following an IV dose of [14C]ontunisertib
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Through study completion, an average of 8 days
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Silke Hüttner, MD, Agomab Therapeutics
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- AGMB129-01-CL-105
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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