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임상시험 NCT06672900은(는) 건강 자원봉사자에 대해 진행중, 모집종료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
A Multi-part Study of ALG-000184 to Evaluate Safety, Tolerability, Pharmacokinetics and Drug-drug Interaction Potential After Single and Multiple Doses in Healthy Volunteers 1상 24
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임상시험 NCT06672900은(는) 기타을(를) 알아보기 위한 연구입니다. 이 연구는 건강 자원봉사자에 대해 진행되며, 1상 중재연구으로 현재 상태는 진행중, 모집종료입니다. 연구는 2025년 1월 9일에 시작되어 24명의 참여자를 모집하고 있습니다. Aligos Therapeutics이(가) 진행하며, 2025년 7월 7일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 2월 3일에 갱신되었습니다.
간단한 개요
This Phase 1 study consists of two parts, all conducted in healthy volunteers (HVs).
In Part 1, the drug-drug interaction (DDI) potential of ALG-000184 will be explored with Itraconazole; participants will be assigned to receive multiple doses of ALG-000184 and Itraconazole over a two week period.
In Part 2, the drug-drug interaction (DDI) potential of ALG-000184 will be explored with Carbamazepine; participants wi...
더 보기공식 제목
A Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of Multiple Doses of ALG-000184.
질환명
건강 자원봉사자기타 연구 식별자
- ALG-000184-204
NCT 번호
실제 연구 시작일
2025-01-09
최신 업데이트 게시
2025-02-03
예상 연구 완료일
2025-07-07
계획된 등록 인원
24
연구종류
중재연구
단계/상
1상
상태
진행중, 모집종료
키워드
Healthy Volunteer
ALG-000184
ALG-000184
주요 목적
기타
설계 할당
비랜덤화 배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적ALG-000184 Single or multiple doses of ALG-000184, an investigational HBV capsid assembly modulator | ALG-000184 Study Investigational Product |
실험적Carbamazepine Multiple doses of carbamazepine, a strong CYP3A4 inducer, to evaluate potential drug-drug interactions with ALG-000184 | Carbamazepine Commercially available supply. ALG-000184 Study Investigational Product |
실험적Itraconazole Multiple doses of itraconazole, a strong CYP3A4 inhibitor, to evaluate potential drug-drug interactions with ALG-000184. | Itraconazole (Sporanox) Commercially available supply. ALG-000184 Study Investigational Product |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Area under the concentration time curve [AUC] | Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of itraconazole (Part 1) | Up to 24 days |
Area under the concentration time curve [AUC] | Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2) | Up to 29 days. |
Time to maximum plasma concentration [Tmax] | Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2) | Up to 29 days |
Time to maximum plasma concentration [Tmax] | Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Itraconazole (Part 1) | Up to 24 days |
Maximum plasma concentration [Cmax] | Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2) | Up to 29 days |
Maximum plasma concentration [Cmax] | Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Itraconazole (Part 1) | Up to 24 days |
Minimum plasma concentration [Cmin] | Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of itraconazole (Part 1) | Up to 24 days |
Minimum plasma concentration [Cmin] | Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2) | Up to 29 days |
C0 [predose] | Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of itraconazole (Part 1) | Up to 24 days |
C0 [predose] | Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2) | Up to 29 days |
Half-life [t1/2] | Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of itraconazole (Part 1) | Up to 24 days |
Half-life [t1/2] | Pharmacokinetic parameters of ALG-001075 and metabolite ALG-000302 after multiple doses of Carbamazepine (Part 2) | Up to 29 days |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The number and severity of treatment emergent adverse events in up to n=24 participants as assessed by DAIDS v2.1(July 2017) | Up to 24 days for Part 1 |
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The number and severity of treatment emergent adverse events in up to n=24 participants as assessed by DAIDS v2.1(July 2017) | Up to 29 days for Part 2 |
Mean Change from Baseline QTc at different exposure levels | Evaluate the concentration-QT relationship of ALG-000175 and metabolite ALG-000302 to determine the QTc prolongation potential of ALG-000184. | Up to 24 days for Part 1. |
Mean Change from Baseline QTc at different exposure levels | Evaluate the concentration-QT relationship of ALG-000175 and metabolite ALG-000302 to determine the QTc prolongation potential of ALG-000184. | Up to 29 days for Part 2. |
참여 도우미
적격성 기준
연령대
성인
최소 연령
18 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
- Male or female between 18 and 55 years of age.
- BMI 18.0 to 32.0 kg/m^2
- Female participants must have a negative serum pregnancy test at screening.
- Subjects must have a 12-lead electrocardiogram (ECG) that meets the protocol criteria.
- Participants with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation.
- Participants with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc.
- Participants with a history of clinically significant drug allergy.
- Participants with excessive use of alcohol defined as regular consumption of ≥14 standard drinks/week (US CDC 2022)
- Participants that are unwilling to abstain from alcohol use for 1 week prior to start of the study through end of study follow up.
- Participants with positive results for urine drug screen, alcohol or cotinine test at screening and Day -1.
- Participants with Hepatitis A, B, C, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection.
- Participants with sensitivity to CYP3A4 or P-gp substrates, inhibitors/inducers.
- Participants with clinically significant abnormal vital signs or physical examination.
- Participants with renal dysfunction (e.g., estimated creatinine clearance <90 mL/min/1.73 m^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula)
Aligos Therapeutics연락처 정보가 없습니다.
1 1개국에 임상시험 장소
Texas
PPD Austin Research Unit, Austin, Texas, 78744, United States