A Study to Assess the Food Effect and the Relative Bioavailability of the Cabotegravir (CAB) Pediatric Dispersible Tablet (DT) Formulation

Exclusion Criteria

• •History or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
• •History of seizures, and participants are required to have been seizure free, off anti epileptic drugs for a minimum of 2 years and will only be considered for enrollment following discussion with the Medical Monitor
• •Abnormal blood pressure as determined by the investigator.
• •Medical history of cardiac arrhythmias, prior myocardial infarction in the past 3 months, or cardiac disease or a family or personal history of long QT syndrome.
• •A pre-existing condition interfering with normal gastrointestinal anatomy or motility (e.g., gastroesophageal reflux disease, gastric ulcers, gastritis), hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study intervention.
• •Known suspected active Coronavirus disease 2019 (COVID-19) infection OR contact with an individual with known COVID-19 , within 14 days of study enrollment
• •Any acute laboratory abnormality at screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound.
• •Any Grade 2 to 4 laboratory abnormality at screening, with Creatine Phosphokinase and lipid abnormalities (e.g., total cholesterol, triglycerides), and ALT abnormalities, will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the sponsor.
• •A positive test result for drugs of abuse (including marijuana), alcohol, or tobacco (indicating active current smoking) at screening or before the first dose of study intervention.
• •Unable to refrain from the use of prescription or non-prescription drugs as detailed in the protocol.
• •Unwillingness to abstain from excessive consumption of any food or drink detailed in the protocol.
• •Would not be able to accommodate the blood loss during participation in the study
• •Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
• •Current enrollment or past participation in another investigational study as detailed in the protocol.
• •Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing. - Current enrollment or past participation in this clinical study.
• •Positive hepatitis B and/or C test result at screening or within 3 months prior to first dose of study intervention.
• •Positive pre-study drug/alcohol screen, including Tetrahydrocannabinol
• •Positive Human immunodeficiency virus (HIV) antibody test (4th generation assay required).
• •Regular use of tobacco- or nicotine-containing products within 6 months prior to screening
• •History of regular alcohol consumption within 6 months of the study,
• •History of sensitivity, prior intolerance or hypersensitivity to any of the study interventions, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.
• •Participant and/or his her family is part of sponsor, clinical site, third party personnel.