A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: TRIUMEQ; DOVATO
Intervention description: TRIUMEQ will be available as fixed dose combination (FDC) dispersible tablets to be administered orally as a dispersion.; DOVATO will be available as FDC dispersible tablets to be administered orally as a dispersion.
Intervention MeSH terms: Abacavir, dolutegravir, and lamivudine drug combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a randomized, single-dose, 2-cohort, 2-period crossover study.
Masking: None (Open Label)
Masking description: This is an open-label study
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: TRIUMEQ; DOVATO; Pharmacokinetics; Food effect; Dolutegravir; Abacavir; Lamivudine

Summary:

      This study will assess the effect of food on the pharmacokinetics (PK) of pediatric
      formulations of TRIUMEQ (dolutegravir [DTG] 5 milligrams [mg]/abacavir [ABC] 60 mg/lamivudine
      [3TC] 30 mg) dispersible tablets and DOVATO (DTG 5 mg/3TC 30 mg) dispersible tablets in
      healthy adult participants. Additionally, safety and tolerability of these formulations will
      also be assessed. TRIUMEQ and DOVATO are registered trademarks of GlaxoSmithKline group of
      companies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must be 18 to 50 years of age inclusive, at the time of signing the
             informed consent.

          -  Participants who are 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 (history and ECG).

          -  Body weight >=50.0 kilograms (kg) (110 pounds [lbs.]) for males and >=45 kg (99 lbs.)
             for females and body mass index within the range 18.5 to 31.0 kilogram per meter
             square (kg/m^2, inclusive).

          -  A male participant is eligible to participate if they agree to use contraceptive
             methods.

          -  A female participant is eligible to participate if she is not pregnant (, not
             lactating or breastfeeding, and at least 1 of the following conditions applies: Is not
             a woman of childbearing potential (WOCBP) OR Is a WOCBP and using a non-hormonal
             contraceptive method that is highly effective

          -  Capable of giving signed informed consent

          -  Documentation that the participant is negative for the human leukocyte antigen (HLA)
             B*5701 allele.

        Exclusion Criteria:

          -  Current or chronic history of liver disease or known hepatic or biliary abnormalities
             (with the exception of Gilbert's syndrome or asymptomatic gallstones).

          -  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.

          -  QT interval corrected for heart rate according to Fridericia's formula (QTcF) >450
             milliseconds (msec).

          -  A participant with known or suspected active coronavirus disease (COVID-19) infection
             OR contact with an individual with known COVID-19, within 14 days of study enrollment.

          -  Presence of hepatitis B surface antigen at screening or within 3 months prior to
             starting study intervention.

          -  Positive hepatitis C antibody test result at screening or within 3 months prior to
             starting study intervention AND positive on reflex to hepatitis C ribonucleic acid
             (RNA).

          -  Positive human immunodeficiency virus (HIV)-1 and -2 antigen/antibody immunoassay at
             screening.

          -  Alanine aminotransferase (ALT) >1.5 × upper limit of normal (ULN). A single repeat of
             ALT is allowed within a single screening period to determine eligibility.

          -  Bilirubin >1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is
             fractionated and direct bilirubin <35%). A single repeat of any laboratory abnormality
             is allowed within a single screening period to determine eligibility.

          -  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 the exception of creatine
             phosphokinase (CPK) and lipid abnormalities (e.g., total cholesterol, triglycerides),
             and ALT (described above), 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 single repeat of any laboratory abnormality is allowed
             within a single screening period to determine eligibility.

          -  A positive test result for drugs of abuse (including marijuana), alcohol, or cotinine
             (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 including
             vitamins, herbal and dietary supplements (including St. John's wort) within 7 days (or
             14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is
             longer) prior to the first dose of study intervention and for the duration of the
             study until completion of the follow-up visit, unless, in the opinion of the
             investigator and ViiV Healthcare (VH)/GlaxoSmithKline medical monitor, the medication
             will not interfere with the study procedures or compromise participant safety.

          -  Unwillingness to abstain from excessive consumption of any food or drink containing
             grapefruit and grapefruit juice, Seville oranges, blood oranges, or pomelos or their
             fruit juices within 7 days prior to the first dose of study intervention(s) until the
             end of the study.

          -  Participation in another concurrent clinical study or prior clinical study (with the
             exception of imaging trials) prior to Day 1 of Period 1 in the current study: 30 days,
             5 half-lives, or twice the duration of the biological effect of the study intervention
             (whichever is longer).

          -  Where participation in the study would result in donation of blood or blood products
             in excess of 500 milliliter (mL) within 60 days.

          -  Estimated serum creatinine clearance (Chronic Kidney Disease Epidemiology
             Collaboration [CKD-EPI]) <90 milliliter per minute (mL/min).

          -  History of regular alcohol consumption within 6 months of the study, defined as an
             average weekly intake of >14 units for males or >7 drinks for females.

          -  Unable to refrain from tobacco or nicotine-containing products within 1 month prior to
             screening.

          -  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.