- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03961932
Safety and Pharmacokinetics of Linzagolix in Female Subjects With Normal and Impaired Renal Function
Evaluation of the Safety and Pharmacokinetics of a Single Dose of Linzagolix in Female Subjects With Normal and Impaired Renal Function
연구 개요
상세 설명
This is a Phase 1, non-randomized, open label, single-dose study to evaluate the effect of varying degrees of impaired renal function (i.e., mild, moderate, severe Renal Impairment (RI), and End-Stage Renal Disease (ESRD) on hemodialysis) on the PK, safety, and tolerability of linzagolix and its major metabolite, KP017.
Up to 40 adult female participants will be enrolled.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Florida
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Orlando, Florida, 미국, 32809
- Clinical Site
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Minnesota
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Saint Paul, Minnesota, 미국, 55114
- Clinical Site
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Key Inclusion Criteria:
Renal Impaired Subjects
- Adult female, ≥ 18 years of age at screening
- Has a BMI ≥ 18.0 and ≤ 42.0 kg/m^2 and weight ≥ 40 kg, at screening
Aside from RI, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, electrocardiograms (ECGs), and screening clinical laboratory profiles, as deemed by the Principal Investigator (PI) or designee
Subjects with mild, moderate, or severe RI:
Has estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) equation at screening as follows:
- Severe RI only: ≤ 29 mL/min/1.73m^2 not on hemodialysis
- Moderate RI only: 30 - 59 mL/min/1.73m^2
- Mild RI only: 60 - 89 mL/min/1.73m^2
Has a stable renal function with no clinically significant change in renal status at least 1 month prior to study drug administration and is not currently or has not been previously on hemodialysis for at least 1 year
Subjects with ESRD:
- Subject is maintained on a stable hemodialysis regimen at least 3 times a week for at least 3 months prior to dosing
Healthy Subjects
- Health adult female will be matched to subjects with RI
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee
- Baseline eGFR ≥ 90 mL/min/1.73m^2 at screening, based on the MDRD equation. Actual creatinine clearance, as determined by a 24-hour urine collection, may be used in place of or in conjunction with the MDRD equation at the PI's discretion
Key Exclusion Criteria:
Renal Impaired Subjects
- Had any major surgery within 4 weeks prior to dosing
- Presence of functioning renal transplant
- Has a surgical (e.g., hepatectomy, nephrectomy, digestive organ resection) or medical condition other than RI which might significantly alter the absorption, distribution, metabolism, or excretion of linzagolix and its metabolites, or which may jeopardize the subject's safety in case of participation in the study, in the opinion of the PI or designee
Healthy Subjects
- Has any clinically significant illness, as judge by the PI or designee, within 4 weeks prior to dosing
- Has laboratory values at screening or check-in which are deemed to be clinically significant (especially derangement within liver function test), unless agreed in advance by the PI and the Sponsor
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Normal Renal Function
Healthy participants with Normal Renal Function (estimated Glomerular Filtration Rate (eGFR) ≥ 90 mL/min/1.73m^2)
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200mg linzagolix의 단일 용량(100mg의 2정)을 공복 상태에서 경구 투여합니다.
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실험적: Mild Renal Impairment
Presence of Mild Renal Impairment (eGFR 60-89 mL/min/1.73m^2)
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200mg linzagolix의 단일 용량(100mg의 2정)을 공복 상태에서 경구 투여합니다.
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실험적: Moderate Renal Impairment
Presence of Moderate Renal Impairment (eGFR 30-59 mL/min/1.73m^2)
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200mg linzagolix의 단일 용량(100mg의 2정)을 공복 상태에서 경구 투여합니다.
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실험적: Severe Renal Impairment
Presence of Severe Renal Impairment (eGFR ≤ 29 mL/min/1.73m^2),
not on hemodialysis
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200mg linzagolix의 단일 용량(100mg의 2정)을 공복 상태에서 경구 투여합니다.
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실험적: End-Stage Renal Disease
Presence of End-Stage Renal Disease (ESRD) requiring hemodialysis
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200mg linzagolix의 단일 용량(100mg의 2정)을 공복 상태에서 경구 투여합니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Plasma pharmacokinetic (PK) parameter Cmax of linzagolix and of KP017
기간: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
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Measurement of effect of renal impairment on PK of linzagolix and its metabolite KP017 by assessment of the maximum plasma concentration (Cmax).
Cmax directly determined from the plasma concentration-time profiles
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predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
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Plasma PK parameter Tmax of linzagolix and of KP017
기간: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
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Measurement of effect of renal impairment on PK of linzagolix and its metabolite KP017 by assessment of the Time to reach Cmax (Tmax)
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predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
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Plasma PK parameter AUC0-t of linzagolix and of KP017
기간: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
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Measurement of effect of renal impairment on PK of linzagolix and its metabolite KP017 by assessment of the AUC0-t (area under the concentration time curve, from time 0 to the last observed non-zero concentration)
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predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
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Plasma PK parameter T1/2 of linzagolix and of KP017
기간: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
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Measurement of effect of renal impairment on PK of linzagolix and its metabolite KP017 by assessment of the T1/2 (Terminal half life)
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predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Treatment emergent Adverse Events
기간: Day 1 to 14 days post-dose
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Assessment of safety and tolerability of a single dose linzagolix in renal impaired subjects compared with healthy control subjects by assessing the number, frequency and severity of treatment emergent Adverse Events
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Day 1 to 14 days post-dose
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: ObsEva SA, Geneva
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
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린자골릭스에 대한 임상 시험
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