NL-OMON50534已完成不适用
Phase I, Open-Label, 2-Period, Single-Sequence Study to Evaluate the Mass Balance and Absorption, Disposition, Metabolism and Excretion of [14C] enpatoran, and the Absolute Bioavailability of Enpatoran in Healthy Male Participants - Enpatoran Human Mass Balance and Absolute Bioavailability Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Are 18 to 55 years of age at the time of signing the informed consent.
- •Type of Participant and Disease Characteristics
- •2. Are overtly healthy as determined by medical evaluation, including medical
- •history, physical examination, laboratory tests, and cardiac monitoring (blood
- •pressure, heart rate and 12 lead ECG). Rescreening might be permitted as
- •described in Section 5.4 of the protocol.
- •3. Have a body weight within 50 to 110 kg and BMI within the range >= 18.0 and <=
- •30.0 kg/m2 (inclusive).
- •Sex and Contraception/Barrier Requirements
- •4. Are Male
- •The investigator confirms that each participant agrees to use an appropriate
- •contraception and barriers, if applicable. The contraception, barrier, and
- •pregnancy testing requirements are below.
- •Contraceptive use will be consistent with local regulations on contraception
- •methods for those participating in clinical studies.
- •Male participants
- •Agree to the following during the study intervention period and for at least
- •3 months after the last dose of study intervention:
- •Refrain from donating sperm
- •PLUS, either:
- •Abstain from any activity that allows for exposure to ejaculate.
- •Use a male condom:
- •When having sexual intercourse with a WOCBP, who is not currently pregnant,
- •and instruct her to use a highly effective contraceptive method
- •with a failure rate of <1% per year, as described in Appendix 3, since a condom
- •may break or leak.
- •When engaging in any activity that allows for exposure to ejaculate.
- •Note: Also use male condom when having sexual intercourse with a pregnant
- •Informed Consent
- •5. Capable of giving signed informed consent, as indicated in Appendix 2 of the
- •protocol which includes compliance with the requirements and restrictions
- •listed in the ICF and this protocol.
排除标准
- •Medical Conditions
- •1. History or presence of clinically relevant respiratory, gastrointestinal,
- •renal, hepatic, hematological, lymphatic, neurological, cardiovascular,
- •psychiatric, musculoskeletal, genitourinary, immunological, dermatological,
- •connective tissue diseases or disorders.
- •2. Prior history of cholecystectomy or splenectomy, and any clinically relevant
- •surgery within 6 months prior to Screening.
- •3. Any surgical or medical condition which might significantly alter the ADME
- •of drugs, or which may jeopardize the participant in case of participation in
- •4. History of any malignancy.
- •5. History or presence of epilepsy, neurological disorders with seizure
- •propensity or undiagnosed loss of consciousness, severe head trauma within 6
- •months or severe depression within 12 months prior to Screening), or
- •neuropsychiatric conditions.
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