A Study to Investigate the Relative Bioavailability and Food Effect of Tablet for Oral Suspension of Sonrotoclax in Healthy Adults
A Phase 1, Single-dose, Open-label, Randomized, Crossover Study in Healthy Adult Participants to Evaluate Relative Bioavailability and Food Effect of Tablet for Oral Suspension of Sonrotoclax
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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Western Australia
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Joondalup、Western Australia、オーストラリア、WA 6027
- 募集
- Linear Early Phase
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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:
- 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 who are overtly healthy as determined by no clinically significant findings from 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:
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive.
- An absolute B-cell count of > 150 cells per microliter (cells/μL). If the B-cell count is < 150 cells/μL, the assessment will be repeated. If the repeat value is > 150 cells/μL, the participant may be enrolled after consultation with the medical monitor.
- Female participants of non-childbearing potential who meet any of the following criteria:
- Surgically sterile (ie, through tubal ligation, bilateral salpingectomy, bilateral oophorectomy, or hysterectomy).
- Postmenopausal, defined as: with no spontaneous menses for ≥ 12 months in the absence of prior chemotherapy, tamoxifen, toremifene, or ovarian suppression and follicle stimulating hormone (FSH) in the postmenopausal range.
- Male participants are eligible if vasectomized or if they agree to the use of barrier contraception with other highly effective methods if sexually active with women of childbearing potential, during study treatment and for at least 7 days after the last dose of study treatment
Exclusion Criteria:
- Significant medical history or conditions: significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator or designee.
- Investigator discretion: participants who, in the opinion of the Investigator or designee, should not participate in the study for any other reason.
- Hypersensitivity or allergies: history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the Investigator or designee.
- Stomach or intestinal surgery: history of gastrointestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed).
- Surgery or trauma: major surgical procedure or significant traumatic injury within 3 months prior to check-in or anticipation of the need for major surgery during the study.
- Medications affecting drug metabolism: use or intent to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St.John's wort, moderate/strong CYP3A inhibitors or inducers, or P-glycoprotein (P-gp)/breast cancer resistance protein (BCRP) inhibitors, within 30 days prior to dosing
- Infections: evidence of any infections (bacterial, viral, fungal, parasitic) within 4 weeks prior to the first dose of study treatment, as determined by the Investigator (or designee).
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:他の
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- 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:Sonrotoclax Tablet for Oral Suspension
Participants will receive each of the following treatments as a single dose on 3 separate occasions with an 8-day washout in between:
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Administered orally
他の名前:
Administered orally
他の名前:
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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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Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) for Sonrotoclax
時間枠:Approximately 20 days
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Approximately 20 days
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Area under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) for Sonrotoclax
時間枠:Approximately 20 days
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Approximately 20 days
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Maximum Observed Plasma Concentration (Cmax) of Sonrotoclax
時間枠:Approximately 20 days
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Approximately 20 days
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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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Time of the Maximum Observed Concentration (Tmax) for Sonrotoclax
時間枠:Approximately 20 days
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Approximately 20 days
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Apparent Terminal Elimination Half-life (t1/2) for Sonrotoclax
時間枠:Approximately 20 days
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Approximately 20 days
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Apparent Total Clearance (CL/F) for Sonrotoclax
時間枠:Approximately 20 days
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Approximately 20 days
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Apparent Volume of Distribution (Vz/F) for Sonrotoclax
時間枠:Approximately 20 days
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Approximately 20 days
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Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
時間枠:Up to approximately 47 days
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Up to approximately 47 days
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Number of Participants with Abnormal Clinically Significant Electrocardiogram (ECG) Values
時間枠:Up to approximately 47 days
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Clinically significant ECG values include a prolonged QT interval, presence of atrial fibrillation or other significant arrhythmia.
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Up to approximately 47 days
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Number of Participants with Clinically Significant Vital Signs Measurements
時間枠:Up to approximately 47 days
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Vital signs include pulse rate, body temperature, and blood pressure.
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Up to approximately 47 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
その他の研究ID番号
- BGB-11417-110
- CT-2026-CTN-01536-1 (その他の識別子:Australia Therapeutic Goods Administration (TGA):)
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個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- CSR
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
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