- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01387087
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP015K Following Single Oral Doses to Healthy Volunteers
연구 개요
상세 설명
Subjects will be confined to the clinical research unit for five days. Some subjects will participate in two confinement periods. Subjects will receive a follow-up phone call to assess safety seven days after the administration of the single dose of study drug.
Subjects will be assigned to one of nine sequential groups A, B, C, D, E, F, G, H, or I. In each group, 6 subjects will be randomized to ASP015K and 2 subjects will be randomized to placebo. Subjects in group F will participate in two treatment periods. Subjects in the first treatment period of group F will have a single study drug dose administered in the fasted state. Subjects in the second treatment period of group F will have a single study drug dose administered immediately following a standard FDA recommended high-fat breakfast.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Florida
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Miami, Florida, 미국, 33014
- Clinical Pharmacology of Miami
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Minnesota
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St. Paul, Minnesota, 미국, 55114
- Prism Research
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- If female, the subject is at least 2 years post menopausal or is surgically sterile per documentation provided by a third party medical professional and the subject is not pregnant as documented by a negative serum pregnancy test
- If male, the subject agrees to sexual abstinence and/or to use a highly effective method of birth control during the study period
- Subject is medically healthy, with no clinically significant abnormalities on medical history or abnormalities observed upon physical examination or 12 lead electrocardiogram (ECG)
- Subject's fasting clinical laboratory values are within normal limits
- Subject is a non-smoker and has not used tobacco for a minimum of 3 months
- Subjects must weigh at least 45 kg and have a Body Mass Index (BMI) of 18-32 kg/m2
Exclusion Criteria:
- Subject has a positive test for hepatitis C antibody, or positive for hepatitis B surface antigen (HBsAg)
- Subject has a history of the human immunodeficiency virus (HIV) antibody
- Subject has a history of severe allergic or anaphylactic reactions
- Subject has a history of chronic diarrhea
- Subject has been vaccinated within the last 60 days prior to study drug administration
- Subject has a previous history of any clinically significant neurological, gastrointestinal, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that, in the Investigator's opinion, would preclude participation in the study
- Subject has had clinically significant illness within 1 month prior to study drug administration
- Subject has a history of hemorrhoids
- Subject has a history of drug or alcohol abuse or a positive urine screen for alcohol or drugs of abuse and/or illegal drugs
- Subject has had treatment with prescription medication (except hormone replacement therapy and acetaminophen), complementary and alternative medicines (CAM) within 14 days, over-the-counter products within 1 week, or alcohol, caffeine or grapefruit juice within 24 hours prior to study drug administration
- Subject has had treatment with another investigational drug or approved therapy for investigational use within 30 days or 10 half-lives, whichever is longer, prior to study drug administration or has participated in a prior group in the current study
- Subject has a history of blood donation within 30 days prior to study drug administration or has donated plasma within 7 days prior to study drug administration
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Group A
Lowest dose, all males, fasting
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경구
|
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실험적: Group B
Second lowest dose, all males, fasting
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경구
|
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실험적: Group C
Third lowest dose, all males, fasting
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경구
|
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실험적: Group D
Middle dose, all males, fasting
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경구
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실험적: Group E
Third lowest dose, all females, fasting
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경구
|
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실험적: Group F
Third highest dose, all males, fasting then fed
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경구
|
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실험적: Group G
Second highest dose, all males, fasting
|
경구
|
|
실험적: Group H
Highest dose, all males, fasting
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경구
|
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실험적: Group I
Second highest dose, all females, fasting
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경구
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위약 비교기: Placebo Group A
all male, fasting
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경구
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위약 비교기: Placebo Group B
all male, fasting then fed
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경구
|
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위약 비교기: Placebo Group C
all female, fasting
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경구
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Safety and tolerability assessed through vital signs, electrocardiograms (ECGs), physical exams, reports of adverse events, and analysis of blood and urine samples
기간: 8 days
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8 days
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Pharmacokinetic assessment through the analysis of blood and urine samples
기간: Up to Day 4
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Up to Day 4
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Pharmacodynamic assessment through the analysis of blood samples
기간: Up to Day 4
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Up to Day 4
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 015K-CL-HV01
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