A Study to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-58067 in Healthy Participants
An Open-Label, Parallel Group Study Designed to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-58067 in Healthy Participants
This study is being done to understand how the body processes the study drug (BGB-58067) when it is taken together with other medicines.
BGB-58067 is mainly broken down in the body by a liver enzyme called CYP3A. Some medicines can affect how this enzyme works. For example, certain medicines can increase the production of the enzyme (called inducers), while others can block or inhibit its activity (called inhibitors). This may change how much of the study drug is present in the bloodstream.
In this study, we will give BGB-58067 together with two commonly used medicines:
- Part A: Phenytoin (inducer), which can increase the production of the enzyme, and
- Part B: Itraconazole (inhibitor), which can inhibit the activity of the enzyme.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前:Study Director
- 電話番号:1-877-828-5568
- メール:clinicaltrials@beonemed.com
研究場所
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South Australia
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Adelaide、South Australia、オーストラリア、SA 5000
- 募集
- CMAX Clinical Research
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Participants must sign the Informed Consent Form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- Participants must be willing and able to comply with all study requirements.
Participants who are overtly healthy as determined by medical evaluation including medical history, clinical laboratory assessments, vital sign measurements,12-lead electrocardiogram (ECG), and physical examination at screening and check-in as determined by the investigator, with additional requirements as follows:
a. Body Mass Index (BMI) of 18.0 to 32.0 kg/m2 inclusive.
- Female participants must be of no childbearing potential. Note: A female participant is considered of childbearing potential (ie, fertile, following menarche, and until becoming postmenopausal) unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy
- Nonsterile male participants must be willing to use condom and refrain from sperm donation for the duration of the study and for 3 months after the last dose of BGB-58067. An additional highly effective method of birth control is highly recommended for the duration of the study and for 3 months after the last dose of BGB-58067. A sterile man is defined as one for whom azoospermia has been previously demonstrated in a semen sample examination as definitive evidence of infertility. Men with known "low sperm counts" (consistent with "subfertility") are not to be considered sterile for purposes of this study
Exclusion Criteria:
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- Presence or history of relevant seasonal allergies requiring treatment, drug and/or food allergies (ie, allergy to any study drug or excipients, or any significant food allergy that could preclude a standard diet in the study site). Hay fever is not an exclusion criterion unless it is active
- Significant serious skin disease as judged by the investigator, including rash, food allergy, eczema, psoriasis, or urticaria
- History of clinically significant cardiovascular, hematological, renal, hepatic, chronic respiratory, or gastrointestinal (GI) disease; neurological or psychiatric (including suicidal ideation or behavior) disorder; or severe cutaneous adverse reactions (SCAR) such as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), as judged by the investigator.
- Participants with a history of cholecystectomy or gall stones
- Poor venous access that limits phlebotomy
- Positive highly sensitive serum pregnancy test at screening, and positive highly sensitive urine test at admission.
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
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 |
|---|---|
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実験的:Part A: BGB-58067 + Phenytoin (CYP3A Inducer)
Participants will receive BGB-58067 on Day 1 and Day 18 and phenytoin on Days 4 to 20.
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経口投与
Administered orally
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実験的:Part B: BGB-58067 + Itraconazole (CYP3A Inhibitor)
Participants will receive BGB-58067 on Days 1 and 8 and itraconazole on Days 4 to 11.
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経口投与
Administered orally
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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 |
|---|---|
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Part A and Part B: Time of the Maximum Observed Concentration (Tmax) of BGB-58067
時間枠:Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A and Part B: Maximum Observed Concentration (Cmax) of BGB-58067
時間枠:Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A and Part B: Area Under the Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of BGB-58067
時間枠:Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A and Part B: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) of BGB-58067
時間枠:Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A and Part B: Apparent Terminal Elimination Half-life (t1/2) of BGB-58067
時間枠:Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A and Part B: Apparent Total Clearance (CL/F) of BGB-58067
時間枠:Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A and Part B: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BGB-58067
時間枠:Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Part A and Part B: Number of Participants with Adverse Events (AEs)
時間枠:Up to approximately 30 days
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Safety will be assessed by monitoring and recording of all treatment emergent adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v6.0
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Up to approximately 30 days
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協力者と研究者
スポンサー
捜査官
- スタディディレクター:Study Director、BeOne Medicines
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
その他の研究ID番号
- BGB-58067-102
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IPD 共有アクセス基準
IPD 共有サポート情報タイプ
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