Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers

Inclusion Criteria

• Between 18 and 55 years of age inclusive, at the time of signing the informed consent.
• Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
• A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator in consultation with the medical monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. A single repeat of a procedure or lab parameter is allowed to determine eligibility.
• Body weight >= 40 kilogram (kg) and body mass index (BMI) within the range 18.5 to 35 kg /meter square (inclusive).
• Male or female
• A female subject is eligible to participate if she is pre-menopausal, has an intact uterus and cervix, AND is not pregnant (as confirmed by a negative human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies: a) Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation, Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, Documented Bilateral Oophorectomy. b)Reproductive potential and agrees to follow one of the options listed below in the GlaxoSmithKline (GSK) Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until at least five terminal half-lives OR until any continuing pharmacologic effect has ended, whichever is longer (can be up to 66 weeks on study) after the last dose of study medication and completion of the follow-up visit. Female subjects desiring pregnancy or foresee that they might wish to become pregnant within 52 weeks of receiving a CAB LA injection must be excluded. All subjects participating in the study must be counseled on safe sexual practices including the use of effective barrier methods to minimize risk of HIV transmission.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.

Exclusion Criteria

• Liver Function: ALT or AST > upper limit of normal (ULN)
• Total bilirubin >ULN (isolated total bilirubin >ULN is acceptable if total bilirubin is fractionated and direct bilirubin 450 milliseconds (msec):

NOTES: The QTc is the QT interval corrected for heart rate according to Bazette's formula (QTcB), machine-read or manually over-read. QTcB will be used to determine eligibility for an individual subject. Exclusion criteria for screening electrocardiogram (ECG) (a single repeat is allowed for eligibility determination): Heart rate ( 100 beats per minute (bpm) for males and 100 bpm for females; QRS duration: >120 msec; QTc interval: >450 msec for males and females

• The subject's systolic blood pressure is outside the range of 90-140 millimeter (mm) mercury (Hg), or diastolic blood pressure is outside the range of 45-90 mmHg.
• History of clinically significant cardiovascular disease including:

Evidence of previous myocardial infarction (pathologic Q waves, S-T segment changes (except early repolarization); History/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PCTA) or any clinically significant cardiac disease; Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block (2nd degree [type II] or higher), Wolf Parkinson White [WPW] syndrome); Sinus pauses > 3 seconds.

• Any significant arrhythmia which, in the opinion of th