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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
Florida
-
Miami、Florida、アメリカ、33014
- Clinical Pharmacology of Miami
-
-
Minnesota
-
St. Paul、Minnesota、アメリカ、55114
- Prism Research
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 割り当て:ランダム化
- 介入モデル:単一グループの割り当て
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Group A
Lowest dose, all males, fasting
|
オーラル
|
|
実験的:Group B
Second lowest dose, all males, fasting
|
オーラル
|
|
実験的:Group C
Third lowest dose, all males, fasting
|
オーラル
|
|
実験的:Group D
Middle dose, all males, fasting
|
オーラル
|
|
実験的:Group E
Third lowest dose, all females, fasting
|
オーラル
|
|
実験的:Group F
Third highest dose, all males, fasting then fed
|
オーラル
|
|
実験的:Group G
Second highest dose, all males, fasting
|
オーラル
|
|
実験的:Group H
Highest dose, all males, fasting
|
オーラル
|
|
実験的:Group I
Second highest dose, all females, fasting
|
オーラル
|
|
プラセボコンパレーター:Placebo Group A
all male, fasting
|
オーラル
|
|
プラセボコンパレーター:Placebo Group B
all male, fasting then fed
|
オーラル
|
|
プラセボコンパレーター:Placebo Group C
all female, fasting
|
オーラル
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Safety and tolerability assessed through vital signs, electrocardiograms (ECGs), physical exams, reports of adverse events, and analysis of blood and urine samples
時間枠:8 days
|
8 days
|
|
Pharmacokinetic assessment through the analysis of blood and urine samples
時間枠:Up to Day 4
|
Up to Day 4
|
|
Pharmacodynamic assessment through the analysis of blood samples
時間枠:Up to Day 4
|
Up to Day 4
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。