NL-OMON50811已完成不适用
A Phase 1, open-label, single-dose, single-center, mass balance study of IPN60130 following a single 60-mg oral dose of IPN60130 containing 9 µCi of [14C]-IPN60130 in healthy male participants - ADME Study of 14C-IPN60130 in 6 healthy male subjects
Ipsen Pharmaceuticals0 个研究点目标入组 6 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
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. Participant must be 18 to 55 years of age inclusive, at the time of signing
- •informed consent.
- •Type of Participant and Disease Characteristics
- •2. The participant must be generally healthy, in the opinion of the
- •Investigator, as determined by medical history, physical examination, 12-lead
- •ECG, vital signs and clinical laboratory results obtained within 28 days prior
- •to enrolment in the study.
- •3. The participant must have a resting (at least 5 minutes) supine pulse of >40
- •but <100 beats per minute and systolic and diastolic blood pressure (BP)
- •<140/90 mmHg at screening. (Note: BP may be retested twice at intervals of at
- •least 5 minutes. The BP is considered sustained if either the diastolic or
- •systolic value exceeds the limits in all 3 assessments).
- •4. The participant must have a body mass index (BMI) of 18 to 30 kg/m² (both
- •inclusive) (calculated as weight [kg]/height [m²]) and a body weight of 50 kg
- •or more at screening.
- •Male participants:
- •Agree to the following during the study intervention period and for at least 90
- •days after the dose of study intervention:
- •Refrain from donating sperm
- •PLUS, either
- •Be abstinent from heterosexual intercourse as their preferred and usual
- •lifestyle (abstinent on a long term and persistent basis) and agree to remain
- •Must agree to use contraception as detailed below
- •Agree to use a male condom with female partner use of an additional highly
- •effective contraceptive method with a failure rate of <1% per year as described
- •in Appendix 10.4 Contraceptive and Barrier Guidance when having sexual
- •intercourse with a woman of childbearing potential who is not currently
- •Informed Consent
- •6. Capable of giving signed informed consent as described in Appendix 10.1,
- •which includes compliance with the requirements and restrictions listed in the
- •informed consent form (ICF) and in the protocol.
排除标准
- •Medical conditions
- •1. The participant has a history or current evidence of a clinically
- •significant or uncontrolled (in the opinion of the Investigator) disease,
- •including but not limited to the following systems: cardiovascular, infectious,
- •hepatic, renal, haematological, neurological, psychiatric, endocrine,
- •gastrointestinal, reproductive, pulmonary, or ocular. Significant is defined as
- •any disease that, in the opinion of the Investigator, would put the safety of
- •the participant at risk through participation or that could affect the endpoint
- •analysis if the disease/condition worsened during the study.
- •2. The participant has any surgical or medical condition known to interfere
- •with the absorption, distribution, metabolism, or excretion of drugs.
- •3. The participant was hospitalized for any significant medical disorder within
- •the past year, in the opinion of the Investigator.
- •4. The participant has a history of any major surgery within 6 months or
- •anticipated surgery prior to Day-1.
- •5. The participant has a history of alcohol abuse, physical dependence to any
- •opioid, or any history of drug abuse or addiction within 6 months prior to
- •6. The participant has a previously identified allergy or hypersensitivity to
- •components of the study intervention formulation or related compounds or
- •hypersensitivity to any inactive component of the drug product, unless the
- •reaction is deemed irrelevant to the study by the Investigator.
研究者
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