Effect of Carbamazepine on Dolutegravir Pharmacokinetics in Healthy Adult Subjects

Inclusion Criteria:

- Healthy as determined by a responsible and experienced physician, 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 agrees and documents that the finding is unlikely to introduce
additional risk factors and will not interfere with the study procedures.

- Male/females aged between 18 and 65 years of age inclusive, at the time of signing
the informed consent.

- A female subject is eligible to participate if she is of: non-childbearing potential
defined as pre-menopausal females with a documented tubal ligation, bilateral
oophorectomy or hysterectomy [for this definition, "documented" refers to the outcome
of the investigator's/designee's review of the subject's medical history for study
eligibility, as obtained via a verbal interview with the subject or from the
subject's medical records]; or postmenopausal defined as 12 months of spontaneous
amenorrhea [in questionable cases a blood sample with simultaneous follicle
stimulating hormone (FSH) >40 milli international units per milliliter (MIU/mL) and
estradiol <40 picograms (pg)/mL (<147 picomole per liter (pmol/L) is confirmatory];
Child-bearing potential with negative pregnancy test as determined by [serum or
urine] human chorionic gonadotropin (hCG) test at screening or prior to dosing AND
Agrees to use one of the contraception methods for an appropriate period of time (as
determined by the product label or investigator) prior to the start of dosing to
sufficiently minimize the risk of pregnancy at that point. Female subjects must agree
to use contraception until 5 days post-last dose. OR has only same-sex partners, when
this is her preferred and usual lifestyle.

- Body weight >=50 kilograms (Kg) for males and >=45 Kg for females and body mass index
(BMI) within the range 18.5 - 31.0 Kg/m^2 (square meters) (inclusive).

- Alanine aminotransferase, alkaline phosphatase and bilirubin <= 1.5x Upper Limit of
Normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated
and direct bilirubin <35%). A single repeat is allowed for eligibility determination.

- Based on single corrected QT interval (QTc) value: QT duration corrected for heart
rate by Bazett's formula (QTcB) <450 millisecond (msec); or QTc <480 msec in subjects
with Bundle Branch Block.

- A negative HLA-B*1502 allele screening assessment for subjects of Asian ethnicity
only.

- Capable of giving written informed consent, which includes compliance with the
requirements and restrictions listed in the consent form

Exclusion Criteria:

- A positive pre-study drug/alcohol screen.

- A positive test for human immunodeficiency virus (HIV) antibody.

- Pregnant females as determined by positive [serum or urine] hCG test at screening or
prior to dosing.

- History of regular alcohol consumption within 6 months of the study defined as: an
average weekly intake of >14 drinks for males or >7 drinks for females. One drink is
equivalent to 12 g of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine
or 1.5 ounces (45 mL) of 80 proof distilled spirits.

- History of sensitivity to any of the study medications, or components thereof or a
history of drug or other allergy that, in the opinion of the investigator or
GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation. Subjects
will allergy to tricyclic antidepressants should not be enrolled.

- Where participation in the study would result in donation of blood or blood products
in excess of 500 mL within a 56 day period.

- The subject has participated in a clinical trial and has received an investigational
product within the following time period prior to the first dosing day in the current
study: 30 days, 5 half-lives or twice the duration of the biological effect of the
investigational product (whichever is longer).

- Lactating females.

- The subject's systolic blood pressure is outside the range of 90-140 millimeters of
mercury (mmHg), or diastolic pressure is outside the range of 45-90 mmHg, or heart
rate is outside the range of 50-100 beats per minute (bpm) for female subjects or
45-100 bpm for male subjects. A single repeat is allowed for eligibility
determination.

- Exclusion criteria for screening ECG (a single repeat is allowed for eligibility
determination): Heart rate for males <45 and >110 bpm and females <50 and >100 bpm;
PR interval <120 and >220 msec, QRS duration <70 and >120 msec, QTc interval (Bazett)
>450 msec. Evidence of previous myocardial infarction (Does not include ST segment
changes associated with repolarization); any clinically significant arrhythmia which,
in the opinion of the investigator and GSK Medical Monitor, will interfere with the
safety for the individual subject; any conduction abnormality (including but not
specific to left or right incomplete bundle branch block, atrioventricular block [2nd
degree or higher], Wolf Parkinson White [WPW] syndrome), sinus pauses>3 seconds, and
non-sustained or sustained ventricular tachycardia (>=3 consecutive ventricular
ectopic beats).

- Platelets, white blood cell count or hemoglobin below the lower limit of normal. A
single repeat is allowed for eligibility determination.

- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
result within 3 months of screening

- Current or chronic history of liver disease, or known hepatic or biliary
abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

- History of suicide ideation or severe depression.

- History of hepatic porphyria (e.g., acute intermittent porphyria, variegate
porphyria, porphyria cutanea tarda.

- History of previous bone marrow depression (e.g., prior viral or drug related bone
marrow depression)

- 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 medication, unless in the opinion of the
investigator and GSK Medical Monitor the medication will not interfere with the study
procedures or compromise subject safety.

- Unwillingness or inability to follow the procedures outlines in the protocol.