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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 4
- 主要终点
- Plasma Concentration of Rilpivirine (RPV)
研究概览
简要总结
The purpose of this study is to characterize the single dose pharmacokinetics (PK) and evaluate the safety and tolerability of subcutaneous administration of rilpivirine (RPV) long-acting (LA) or RPV LA in combination with cabotegravir (CAB) LA extended release suspensions in different conditions in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) (based on the average value of triplicate ECGs) performed at screening (results must be available on Day -1)
- •Participant must be healthy on the basis of clinical laboratory tests performed at screening (results must be available prior to dosing on Day 1). If there are abnormalities, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- •All women participants must have a negative highly sensitive serum (Beta-human chorionic gonadotropin [Beta-hCG]) pregnancy test at screening and on Day -1
- •A woman must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for at least 72 weeks after receiving the dose of study intervention
- •A male participant (not vasectomized) who is heterosexually active with a woman of childbearing potential must agree to use two effective contraceptive methods for the duration of the study (72 weeks follow-up), or for at least 72 weeks after receiving the dose of study intervention for those who do not complete the study
排除标准
- •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. This may include, but is not limited to, hepatic or renal dysfunction, cardiac disease, vascular, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, neurologic, hematologic, coagulation disorders (including any abnormal bleeding or blood dyscrasias), or psychiatric disturbances
- •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)
- •Participant has known allergies, hypersensitivity, or intolerance to Cabotegravir (CAB) or its excipients
- •Participants with the following ECG findings, if clinically significant: abnormal PR, QRS, and QTc intervals; rhythm abnormalities; evidence of acute ischemic changes
- •Participants with a history of clinically relevant skin disease such as, but not limited to, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria
研究组 & 干预措施
Panel D: RPV LA
Participants will receive one dose of RPV LA (formulation 2) under different conditions (Treatment G and H) on Day 1, based on interim data of Panel B.
干预措施: RPV LA (Drug)
Panel E: RPV LA + Cabotegravir (CAB) LA
Participants will receive one dose of RPV LA (formulation 1) with CAB LA (formulation 3) (Treatment I) on Day 1.
干预措施: RPV LA (Drug)
Panel E: RPV LA + Cabotegravir (CAB) LA
Participants will receive one dose of RPV LA (formulation 1) with CAB LA (formulation 3) (Treatment I) on Day 1.
干预措施: CAB LA (Drug)
Panel A: Rilpivirine (RPV) Long-acting (LA)
Participants will receive one dose of RPV LA (formulation 1) under different conditions (Treatment A and B) on Day 1.
干预措施: RPV LA (Drug)
Panel B: RPV LA
Participants will receive one dose of RPV LA (formulation 2) under different conditions (Treatment C and D) on Day 1.
干预措施: RPV LA (Drug)
Panel C: RPV LA
Participants will receive one dose of RPV LA (formulation 1) under different conditions (Treatment E and F) on Day 1, based on interim data of Panel A.
干预措施: RPV LA (Drug)
结局指标
主要结局
Plasma Concentration of Rilpivirine (RPV)
时间窗: Up to 72 weeks
Plasma samples will be analyzed to determine concentrations of RPV using a validated, specific, and sensitive method.
Plasma Concentration of Cabotegravir (CAB)
时间窗: Up to 72 weeks
Plasma samples will be analyzed to determine concentrations of CAB using a validated, specific, and sensitive method.
次要结局
- Number of Participants with Injection-Site Reactions(Up to 72 weeks)
- Number of Participants With Adverse Events (AEs)(Up to 72 weeks)
- Pain Assessment using Visual Analogue Scale (VAS)(Up to 72 weeks)
- Number of Participants with Abnormalities in 12-Lead Electrocardiograms (ECGs)(Up to 72 weeks)