Drug-Drug Interaction Study of Atumelnant in Healthy Participants
A Phase 1, Open-Label, Two-Cohort Study to Assess the Effect of a Strong CYP3A4 Inducer on the Pharmacokinetics of Atumelnant and the Effect of Atumelnant on the Pharmacokinetics of CYP3A4, P-gp, and MATE1/2-K Substrates in Healthy Participants
調査の概要
詳細な説明
This is a Phase 1, open-label, two-Cohort Study to assess the effect of a strong CYP3A4 inducer on the pharmacokinetics of atumelnant and the effect of atumelnant on the pharmacokinetics of CYP3A4, P-gp, and MATE1/2-K Substrates in healthy participants.
Approximately 20 healthy male and female participants adult male and female (of non-childbearing potential) participants will be enrolled in Cohort 1. Approximately 26 healthy male and female participants adult male and female (of non-childbearing potential) participants will be enrolled in Cohort 2.
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
-
-
Nebraska
-
Lincoln、Nebraska、アメリカ、68502
- Crinetics Study Site
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Healthy adult females of non-childbearing potential (Section 14.2) or healthy adult males, 19-55 years of age, inclusive, at the screening visit.
- BMI ≥18.0 and ≤32.0 kg/m2 at the screening visit.
- Is willing and able to comply with all study procedures and restrictions, including fasting and consumption of protocol-specified standardized meal for required study measurements; inpatient admission; follow-up contact; receipt of rescue therapy, if necessary; abstinence from tobacco, alcohol, drugs, and from strenuous unaccustomed exercise and sports (defined as greater than 30 minutes per day) during the study period.
- Normal adrenocorticotropic hormone (ACTH)-stimulated cortisol test at the screening visit and does not have signs and symptoms of adrenal insufficiency as deemed by the PI or designee.
Exclusion Criteria:
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- Female participant with a positive pregnancy test at the screening visit or at first check-in or who is lactating.
- Female participant of childbearing potential.
- Had prior treatment with atumelnant.
- Participation in another clinical study within 30 days or received any investigational drug within 5 half-lives prior to the first dosing, whichever is longer. The time window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study.
- History or presence of hypersensitivity or idiosyncratic reaction to the study interventions or related compounds.
- Has a blood loss ≥500 mL or donated blood within 3 months prior to the first dosing.
- Unable to refrain from or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, vitamin supplements, or other food supplements within 14 days or 5 half-lives prior to the first dosing, whichever is longer.
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
- 主な目的:処理
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Cohort 1
atumelnant, carbamazepine (CYP3A4 Inducer)
|
Atumelnant, tablets
他の名前:
CYP3A4 inducer
|
|
実験的:Cohort 2
atumelnant, midazolam (CYP3A4 substrate), digoxin (P-gp substrate), metformin (MATE1/2-K substrate)
|
P-gp基質
Atumelnant, tablets
他の名前:
CYP3A4 substrate
MATE1/2-K substrate
|
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 |
|---|---|
|
Cohort 1: Pharmacokinetics (AUC 0-last)
時間枠:Up to Day 34
|
Up to Day 34
|
|
Cohort 1: Pharmacokinetics (AUC 0-inf)
時間枠:Up to Day 34
|
Up to Day 34
|
|
Cohort 1: Pharmacokinetics (Cmax)
時間枠:Up to Day 34
|
Up to Day 34
|
|
Cohort 2: Pharmacokinetics (AUC 0-last)
時間枠:Up to Day 21
|
Up to Day 21
|
|
Cohort 2: Pharmacokinetics (AUC 0-inf)
時間枠:Up to Day 21
|
Up to Day 21
|
|
Cohort 2: Pharmacokinetics (Cmax)
時間枠:Up to Day 21
|
Up to Day 21
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Cohort 1: Number of participants with Treatment Emergent Adverse Events
時間枠:Up to Day 34
|
Up to Day 34
|
|
Cohort 2: Number of participants with Treatment Emergent Adverse Events
時間枠:Up to Day 21
|
Up to Day 21
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CRN04894-131
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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