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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
126
PRA Health Sciences 2
Lenexa, Kansas, United States
PRA Health Sciences 1
Salt Lake City, Utah, United States
PRA Health Sciences
Groningen, Netherlands
Plasma Concentration of Rilpivirine (RPV)
Plasma samples will be analyzed to determine concentrations of RPV using a validated, specific, and sensitive method.
Time frame: Up to 72 weeks
Plasma Concentration of Cabotegravir (CAB)
Plasma samples will be analyzed to determine concentrations of CAB using a validated, specific, and sensitive method.
Time frame: Up to 72 weeks
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.
Time frame: Up to 72 weeks
Number of Participants with Injection-Site Reactions
Number of participants with injection-site reactions will be reported. A study intervention injection-site reaction is any adverse reaction at a subcutaneous study intervention injection-site.
Time frame: Up to 72 weeks
Number of Participants with Abnormalities in 12-Lead Electrocardiograms (ECGs)
Number of participants with abnormalities in 12- lead ECGs (heart rate, PR, QRS and QT corrected \[QTc\]) will be reported.
Time frame: Up to 72 weeks
Pain Assessment using Visual Analogue Scale (VAS)
Pain assessments will be performed by collecting pain intensity scores using 100-millimetre (mm) VAS.
Time frame: Up to 72 weeks
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