Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453
2016년 7월 20일 업데이트: Bial - Portela C S.A.
A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453 in Healthy Male Volunteers
The purpose of this study is to assess the tolerability of BIA 5-453 after six multiple rising dose regimens of BIA 5-453.
연구 개요
상세 설명
Two centres, double-blind, randomised, placebo-controlled study of six dosage regimens of BIA 5-453 in six groups of healthy male subjects.
In each group, the study consisted of a 10-day multiple-dose period. Progression to the next dose level only occurred if the previous dose level was considered to be safe and well tolerated. An appropriate interval separated the investigation of doses to permit a timely review and evaluation of safety data (including plasma exploratory pharmacokinetics) prior to proceeding to a higher dose level.
연구 유형
중재적
등록 (실제)
57
단계
- 1단계
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
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
남성
설명
Inclusion Criteria:
- A signed and dated informed consent form before any study-specific screening procedure was performed.
- Aged between 18 and 45 years, inclusive.
- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead ECG.
- Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must have been able to abstain from smoking during the inpatient stay.
- Have a high probability for compliance with and completion of the study.
Exclusion Criteria:
Medical History
- Any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease.
- Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study Day1.
- History of drug abuse within 1 year before study Day1.
- History of alcoholism within 1 year before Day1. Consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° [10%] wine = 12 g; 4 cL of aperitif, 42° [42%] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15 g
History of any clinically important drug allergy.
Physical and Laboratory Findings
- An automatic ECG QTc interval reading at screening or enrolment >450 ms.
- Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA [3,4-methylenedioxy-methamphetamine; ecstasy]).
Prohibited treatments
- Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (IMP) administration.
- Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 72 before study day -1.
- Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before IMP administration.
- Donation of blood (ie 450 ml) within 90 days before study Day1.
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: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: BIA 5-453 25 mg or placebo
Multiple oral doses of BIA 5-453 25 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
|
Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration
다른 이름들:
The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.
|
|
실험적: BIA 5-453 50 mg or placebo
Multiple oral doses of BIA 5-453 50 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
|
Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration
다른 이름들:
The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.
|
|
실험적: BIA 5-453 100 mg or placebo
Multiple oral doses of BIA 5-453 100 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
|
Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration
다른 이름들:
The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.
|
|
실험적: BIA 5-453 200 mg or placebo
Multiple oral doses of BIA 5-453 200 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
|
Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration
다른 이름들:
The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.
|
|
실험적: BIA 5-453 400 mg or placebo
Multiple oral doses of BIA 5-453 400 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
|
Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration
다른 이름들:
The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.
|
|
실험적: BIA 5-453 600 mg or placebo
Multiple oral doses of BIA 5-453 600 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
|
Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration
다른 이름들:
The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percent of subjects with at least one adverse event
기간: through study completion, an average of 10 days
|
through study completion, an average of 10 days
|
|
|
Percent of subjects by dose group with at least one treatment-emergent adverse event (TEAEs)
기간: through study completion, an average of 10 days
|
Treatment-emergent adverse events are adverse events that occurred either in the 72 hours after dosing or that was present prior to dosing but exacerbated within 72 hours after dosing.
|
through study completion, an average of 10 days
|
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연구 주요 날짜
연구 시작
2007년 9월 1일
기본 완료 (실제)
2008년 7월 1일
연구 완료 (실제)
2008년 7월 1일
연구 등록 날짜
최초 제출
2016년 7월 19일
QC 기준을 충족하는 최초 제출
2016년 7월 20일
처음 게시됨 (추정)
2016년 7월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 7월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 7월 20일
마지막으로 확인됨
2016년 7월 1일
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