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 Suspensio

Completed

Conditions: 10021460
Human immunodeficiency virus syndrome

Registration Number: NL-OMON51507

Lead Sponsor: Janssen-Cilag International NV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Characterize the single-dose pharmacokinetic (PK) of rilpivirine (RPV) after SC<br /><br>administration of rilpivirine long-acting.<br /><br>Characterize the single-dose pharmacokinetic (PK) of cabotegravir (CAB) after<br /><br>SC administration of cabotegravir long-acting</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Evaluate the safety and tolerability of SC administration of rilpivirine<br /><br>long-acting.<br /><br>Adverse events, injection site reactions, vital signs, physical examination,<br /><br>laboratory parameters, nd electrocardiogram (ECG) parameters.</p><br>