Human immunodeficiency virus syndrome
Conditions
Interventions
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.
Panel B: RPV LA
Participants will re
Sponsors
Janssen-Cilag International NV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characterize the single-dose pharmacokinetic (PK) of rilpivirine (RPV) after SC administration of rilpivirine long-acting. Characterize the single-dose pharmacokinetic (PK) of cabotegravir (CAB) after SC administration of cabotegravir long-acting | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the safety and tolerability of SC administration of rilpivirine long-acting. Adverse events, injection site reactions, vital signs, physical examination, laboratory parameters, nd electrocardiogram (ECG) parameters. | — |
Countries
Netherlands
Outcome results
None listed