This is an open-label, dose-escalation study to investigate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter (mg/mL) with Recombinant Human Hyaluronidase PH20 (rHuPH20) (Part A), a single-dose or repeat-dose SC or intramuscular (IM) administration of LA CAB (greater than or equal to) \>=400 mg/mL (Part C), single-dose IM administration of LA CAB Formulation I (Part C Cohort C8) and LA CAB Formulation J (Part C Cohort C11), and a single-dose or repeat-dose IM administration of rilpivirine (RPV) (Part E). Part A of the study (CAB 200 mg/mL with rHuPh20) has been closed to further enrolment based on preliminary results. Part D of the study (CAB \>=400 mg/mL with rHuPH20) will not be conducted due to changes in the study design.
At the time of obtaining informed consent, participants age should be greater than or equal to (>=)18 years and less than or equal to (<=) 55 years.
Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Body weight >=40 kilogram (kg) and body mass index (BMI) within the range >=18 to <=32 kilogram per meter square (kg/m²).
Participants who are negative on a single test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (approved molecular polymerase chain reaction [PCR] laboratory or point of care test), performed on the day of admission. A negative result is required prior to the administration of study intervention on Day 1.
Current presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders.
Current or chronic history of liver disease or known hepatic or biliary abnormalities.
History of ongoing or clinically relevant seizure disorder within the previous 2 years, including participants who have required treatment for seizures within this time period.
Positive SARS-CoV-2 polymerase chain reaction test, having signs and symptoms which in the opinion of the investigator are suggestive of coronavirus disease 2019 (COVID-19) (i.e., fever, cough etc) within 14 days of inpatient admission, or having contact with known COVID-19 positive person/s in the 14 days prior to inpatient admission.
Sequential
Cabotegravir 200 mg/mL
DrugCAB 200 mg/mL will be administered.
Cabotegravir >=400 mg/mL
DrugCAB \>=400 mg/mL will be administered by IM or SC injection.
Cabotegravir Formulation I
DrugCAB Formulation I will be administered by IM injection.
CAB Formulation J
DrugCAB Formulation J will be administered by IM injection.
rHuPH20
DrugrHuPH20 will be administered.
RPV
DrugRPV will be administered by IM injection.
Maximum observed plasma concentration (Cmax) of CAB and RPV
Time of maximum observed plasma concentration (tmax) of Cabotegravir CAB and RPV
Area under the concentration - time curve from time zero to infinity (AUC[0-inf]) of CAB and RPV
Area under the concentration - time curve from time zero to time of last quantifiable concentration or 4 weeks following the injection whichever is earlier (AUC[0-t]) of CAB and RPV
Dose proportionality of CAB and RPV based on AUC(0-inf)
Dose proportionality of CAB and RPV based on AUC(0-t)
Dose proportionality of CAB and RPV based on Cmax
Dose proportionality of CAB and RPV based on plasma concentration
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ViiV Healthcare
Lead sponsor
GlaxoSmithKline
Collaborator
Janssen Sciences Ireland Unlimited Company
Collaborator
