A Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD4954 and the Absolute Bioavailability of AZD4954
2026년 9월 4일 업데이트: AstraZeneca
An Open-Label Study to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD4954 and Absolute Bioavailability of AZD4954 in Healthy Male Participants
This study in healthy volunteers aims to explore blood levels and side effects of the test medicine, and look at how it is broken down when injected into a vein or given as a liquid by mouth. The test medicine will be radiolabelled with a small amount of carbon-14 so it can be tracked in the body.
This two-part study will take place at one site in Nottingham, United Kingdom, and will enroll 8 healthy men in each part, aged 30-65 years.
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
This study in healthy volunteers aims to explore blood levels and side effects of the test medicine, and look at how it is broken down when injected into a vein or given as a liquid by mouth. The test medicine will be radiolabelled with a small amount of carbon-14 so it can be tracked in the body.
This study will take place at one site in Nottingham, United Kingdom.
It is planned to enroll 8 healthy male participants in each part, aged 30-65 years.
In part 1 volunteers will receive a single dose of radiolabelled test medicine as a liquid by mouth. They'll stay in the clinic for up to 24 nights, attend 1 outpatient visit, and take up to 8 weeks to finish the study.
In part 2 volunteers will receive a single dose of test medicine by mouth and, shortly afterwards, a very tiny dose of radiolabelled study medicine by injection into a vein. They'll stay in the clinic for up to 15 nights, attend 1 outpatient visit, and take up to 7 weeks to finish the study.
Blood and urine samples will be collected to do safety tests. Blood, urine and faecal samples will be collected to measure the amount of test medicine and its breakdown products.
연구 유형
중재적
등록 (추정된)
16
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: AstraZeneca Clinical Study Information Center
- 전화번호: 1-877-240-9479
- 이메일: information.center@astrazeneca.com
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
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
- Healthy males aged 30 to 65 years inclusive
- BMI of 18.0 to 35.0 kg/m2 inclusive
- Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)
Exclusion Criteria:
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- Presence or history of clinically significant allergy requiring treatment
- History of clinically significant cardiovascular, renal, hepatic, respiratory, dermatological or gastrointestinal disease, and neurological or psychiatric disorder
- History of cholecystectomy or gall stones
- History of GI surgery
- Acute diarrhoea or constipation in the 7 days before the predicted Day 1
- Participants who do not have suitable veins for multiple venepunctures/cannulation
- Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis
- Evidence of renal impairment at screening
- Participants who have received any IMP in a clinical research study within the 90 days prior to Day 1
- Participants who have previously been administered IMP in this study
- Radiation exposure exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years
- Participants who have been administered IMP in an ADME study in the last 12 months
- Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
- Use of any prescribed or non-prescribed medication including antacids, gastric pH modifying agents, analgesics, herbal remedies, vitamins and minerals within 2 weeks of dosing
- Current smokers or known or suspected history of alcohol or drug abuse
- Excessive intake of caffeine-containing drinks or food
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: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Part 1
Participants in Part 1 will receive a single dose of [14C]AZD4954 Oral Solution.
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Participants in Part 1 will recieve a single dose of [14C]AZD4954 oral solution
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실험적: Part 2
Participants in Part 2 will receive a single unlabelled oral dose of AZD4954 tablet and a radiolabelled IV microtracer dose of [14C]AZD4954.
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Participants in Part 2 will receive a single dose of AZD4954 film-coated tablet by mouth
Participants in Part 2 will receive a single very tiny dose of radiolabelled [14C]AZD4954 Solution for Infusion as a slow injection into a vein
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Amount of AZD4954 excreted (Ae) (Part 1)
기간: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
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Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
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Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
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Amount of AZD4954 excreted expressed as a fraction of dose excreted (Fe) (Part 1)
기간: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
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Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
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Cumulative amount of AZD4954 excreted (CumAe) (Part 1)
기간: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
|
Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
|
Cumulative amount of AZD4954 excreted expressed as a fraction of dose excreted (CumFe) (Part 1)
기간: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
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Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
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Absolute bioavailability (F) based on AUC0-inf (Part 2)
기간: Plasma, urine and faecal samples from pre-dose until up to 336 hours post-dose
|
Absolute bioavailability of AZD4954 oral and IV administration, adjusted for dose
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Plasma, urine and faecal samples from pre-dose until up to 336 hours post-dose
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Maximum observed concentration (Cmax) for AZD4954 and total radioactivity (Parts 1 and 2)
기간: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
|
The PK of AZD4954 and [14C]AZD4954 in plasma and urine, and total radioactivity in plasma and whole blood
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Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
|
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Time of maximum observed concentration (Tmax) for AZD4954 and total radioactivity (Parts 1 and 2)
기간: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
|
The PK of AZD4954 and [14C]AZD4954 in plasma and urine, and total radioactivity in plasma and whole blood
|
Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
|
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Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for AZD4954 and total radioactivity (Parts 1 and 2)
기간: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
|
The PK of AZD4954 and [14C]AZD4954 in plasma and urine, and total radioactivity in plasma and whole blood
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Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
|
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Terminal elimination half-life (T1/2) for AZD4954 and total radioactivity (Parts 1 and 2)
기간: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
|
The PK of AZD4954 and [14C]AZD4954 in plasma and urine, and total radioactivity in plasma and whole blood
|
Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
|
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Area under the curve (AUC) of circulating total radioactivity accounting for 10% or more of the dose (Part 1)
기간: Plasma, urine and faecal samples collected from pre-dose until up to 552 hours post-dose
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Identification of the chemical structure of each metabolite
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Plasma, urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
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80% or more of the radioactivity recovered in excreta (Part 1)
기간: Plasma, urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
Identification of the chemical structure of each metabolite
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Plasma, urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
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Disposition of total radioactivity in plasma and in blood (Part 1)
기간: Plasma, and whole blood samples collected from pre-dose until up to 552 hours post-dose
|
Evaluation of whole blood:plasma concentration ratios for total radioactivity
|
Plasma, and whole blood samples collected from pre-dose until up to 552 hours post-dose
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Sharan Sidhu, MBChB, BAO, MRCS, MFPM, Quotient Sciences
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 19일
기본 완료 (추정된)
2026년 12월 17일
연구 완료 (추정된)
2026년 12월 17일
연구 등록 날짜
최초 제출
2026년 9월 4일
QC 기준을 충족하는 최초 제출
2026년 9월 4일
처음 게시됨 (실제)
2026년 9월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 4일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- D7300C00005
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org.
All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD 공유 기간
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles.
For details of our timelines, please rerefer to our disclosure commitment athttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD 공유 액세스 기준
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environmentVivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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. .