NL-OMON51507已完成不适用
A Phase 1, Single-blind, Randomized, Parallel-group Study in Healthy Participants to Investigate the Single-dose Pharmacokinetics, Safety and Tolerability of Rilpivirine After Subcutaneous Administration of a Rilpivirine Extended-Release Suspension alone, and of Rilpivirine and Cabotegravir After Co-administration with Cabotegravir Extended-Release Suspension - A Study of Rilpivirine Extended-Release Suspension in Healthy Participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
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
- •Each potential participant must satisfy all of the following criteria to be
- •enrolled in the study:
- •1. Participant must be 18 to 55 years of age, extremes included, at screening.
- •2. Participant must be healthy on the basis of physical examination, medical
- •history, vital signs, and 12-lead ECG performed at screening.
- •3. Participant must be healthy on the basis of clinical laboratory tests
- •performed at screening.
- •4. Body mass index between 18.0 and 35.0 kg/m2, extremes included, and body
- •weight not less than 50.0 kg at screening.
- •5. Male or female.
- •Further criteria apply
排除标准
- •1. Participant with a history of or current illness that, in the opinion of the
- •investigator, might confound the results of the study or pose an additional
- •risk in administering study intervention to the participant or that could
- •prevent, limit or confound the protocol specified assessments.
- •2. Participant has a history of malignancy within 5 years before screening
- •(exceptions are squamous and basal cell carcinomas of the skin and carcinoma in
- •situ of the cervix, or malignancy, which is considered cured with minimal risk
- •of recurrence).
- •3. Participant has known allergies, hypersensitivity, or intolerance to
- •Rilpivirine, rHuPH20, or their excipients
- •4. Participant has a history of clinically relevant arrhythmias or history of
- •risk factors for Torsade de Pointes .
- •5. Participants with the following ECG findings, if clinically significant:
- •abnormal PR, QRS, and QTc intervals; rhythm abnormalities; evidence of acute
- •ischemic changes.
- •Further criteria apply
研究者
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