Effect of High-fat Meal on the Pharmacokinetics of TQ-B3139 Capsules
A Study of the Effect of High-fat Meal on the Pharmacokinetics of Oral TQ-B3139 Capsules in Patients With Solid Tumor
연구 개요
연구 유형
등록 (예상)
단계
- 1단계
연락처 및 위치
연구 장소
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Hunan
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Changsha, Hunan, 중국, 410000
- 모병
- Hunan Cancer Hospital
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수석 연구원:
- Nong Yang, Doctor
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연락하다:
- Nong Yang, Doctor
- 전화번호: 0731-89762320
- 이메일: yangnongpi@163.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
1. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1.
2. Life expectancy ≥12 weeks. 3. Patients with confirmed gene mutations, including ALK fusion, ROS1 fusion, MET mutation or amplification.
4. Adequate organ system function. 5.Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.
6.Understood and signed an informed consent form.
Exclusion Criteria:
1. Has other malignancies within 3 years. 2. Has multiple factors affecting oral medication. 3. The toxicity of previous antitumor treatment is not recovered to ≤ grade 1(CTCAE 5.0) .
4. Has received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before the first dose.
5. Has long-term unhealed wounds or fractures. 6. Has a history of psychotropic drug abuse or have a mental disorder. 7. Has any severe and/or uncontrolled disease. 8. Has received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks or 5 half-life of drug elimination (whichever comes first) before the first dose.
9. Has participated in other clinical studies within 4 weeks before enrollment. 10.Using inhibitors or inducers of CYP3A at present. 11. Has receiving Chinese patent medicines with anti-tumor indications in the drug instructions that NMPA approved within 2 weeks before the start of the study treatment.
12. Pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage.
13. Brain metastases with symptoms or symptoms of brain metastases were controlled for less than 2 weeks.
14. In lactation period or plan to breastfeed during the study period. 15.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Cohort 1
TQ-B3139 capsules administered single dose of 600 mg under fasted conditions in day 1 followed by single dose of 600 mg with a high-fat meal in day 5, then TQ-B3139 capsules administered 600mg orally, twice daily.
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TQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle.
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실험적: Cohort 2
TQ-B3139 capsules administered single dose of 600 mg with a high-fat meal in day 1 followed by single dose of 600 mg under fasted conditions in day 5, then TQ-B3139 capsules administered 600mg orally, twice daily.
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TQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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AUC0-t
기간: 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
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To characterize the pharmacokinetics of TQ-B3139 by assessment of area under the plasma concentration time curve from zero to time.
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0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
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AUC0-∞
기간: 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
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To characterize the pharmacokinetics of TQ-B3139 by assessment of area under the plasma concentration time curve from zero to infinity.
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0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
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Cmax
기간: 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
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Cmax is the maximum plasma concentration of TQ-B3139 or metabolite(s).
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0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Tmax
기간: 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
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To characterize the pharmacokinetics of TQ-B3139 by assessment of time to reach maximum plasma concentration.
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0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
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t1/2
기간: 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
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t1/2 is time it takes for the blood concentration of TQ-B3139 or metabolite(s) to drop by half.
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0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
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Objective Response Rate (ORR)
기간: up to 24 months
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Percentage of participants achieving complete response (CR) and partial response (PR).
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up to 24 months
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Progression-free survival (PFS)
기간: up to 24 months
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PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
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up to 24 months
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Disease control rate (DCR)
기간: up to 24 months
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Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
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up to 24 months
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Duration of response (DOR)
기간: up to 24 months
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DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
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up to 24 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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
- TQ-B3139-I-02
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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