Infection, Human Immunodeficiency VirusPhase 1NCT02738931

Relative Bio-availability Study of Dolutegravir and Lamivudine Fixed Dose Combinations

A Phase 1 study testing Dolutegravir 50 mg tablet, Lamivudine 300 mg tablet and Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA) in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Dolutegravir (DTG) and lamivudine (3TC) are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Fixed dose combination (FDC) tablets of existing approved drugs are preferred by many patients and offer the potential for increased patient… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Infection, Human Immunodeficiency Virus
What is being tested?: Dolutegravir 50 mg tablet, Lamivudine 300 mg tablet and Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: May 2016to Jun 2016
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Between 18 and 65 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 evaluation (history, electrocardiogram [ECG]).
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 if required agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Body weight >= 50 kilogram (kg) (110 pounds [lbs.)] for men and >= 45 kg (99 lbs) for women and body mass index (BMI) within the range 18.5-31.0 kg/meter square (m^2) (inclusive)
Male or Female
Female subject of non-reproductive potential: is eligible to participate if she is not pregnant (as confirmed by a negative serum or urine human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies:

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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, Hysterectomy, Documented Bilateral Oophorectomy
Postmenopausal defined as 12 months of spontaneous amenorrhea; in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in protocol.

Who cannot join

Alanine transaminase (ALT) and bilirubin >1.5xupper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
QT interval corrected for heart rate according to Fridericia's formula (QTcF) > 450 millisecond (msec)
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 ViiV/GlaxoSmithKline (GSK) Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
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 gram (g) of alcohol: 12 ounces (360 milliliter [mL]) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.

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Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 1 month prior to screening.
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 Medical Monitor, contraindicates their participation.
Creatinine clearance (CrCL) <60 mL/minute (min)
A positive hepatitis B surface antigen (HBsAg) or a or a positive hepatitis B core antibody with a negative hepatitis B surface antibody, positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
A positive pre-study drug/alcohol screen.
A positive test for human immunodeficiency virus (HIV) antibody.
Where participation in the study would result in donation of blood or blood product in excess of 500 mL within 56 days.
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).
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.

Trial locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
Overland Park, Kansas, 66211

Other trials in United States

About this study

Official title: A Phase I, Relative Oral Bioavailability Study of Different Fixed Dose Combinations of Dolutegravir and Lamivudine in Healthy Subjects

The purpose of the present study is to evaluate the relative bioavailability of two experimental FDC tablets of DTG and 3TC relative to co-administration of the single entity products in healthy adult subjects.

This study will be conducted as a randomized, open label three-way, crossover design with 6 treatment sequences in approximately 30 subjects. Each subject will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods each with a single dose of study drug and a follow-up visit within 7-14 days after the last dose of study drug. There will be at least 7 days washout between dosing periods. The total duration of participation of a subject in this study will be approximately 9 weeks.

Conditions: Infection, Human Immunodeficiency Virus
Being tested: Dolutegravir 50 mg tablet, Lamivudine 300 mg tablet, Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA), Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB)
Keywords: dolutegravir, lamivudine, Bioavailability, fixed dose combinations
Medical subject headings: Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dolutegravir 50 mg tabletDrug
A white, film-coated, round tablet debossed with SV 572 on one side and 50 on the other side. Single dose of one tablet will be administered with 240 mL of water.
Lamivudine 300 mg tabletDrug
Gray, diamond-shaped tablet, engraved "GX EJ7" on one side and plain on the other side. Single dose of one tablet will be administered with 240 mL of water.
Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA)Drug
Immediate release oval tablet embossed 'gsk' on one face with white film coat. Single dose of one tablet will be administered with 240 mL of water.
Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB)Drug
Immediate release oval tablet embossed 'gsk' on one face with white film coat. Single dose of one tablet will be administered with 240 mL of water.

Study groups in NCT02738931
Study group	Role	What they receive
Treatment Sequence ABC	Experimental	Subject will receive reference treatment DTG 50mg and 3TC 300mg administered as single entity tablets (treatment A) in period 1, experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablet (Product Code AA, treatment B) in period 2 and experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablet (Product Code AB, treatment C) in period 3 in a fasted state. There will be at least 7 days washout between dosing periods. Receives: Drug: Dolutegravir 50 mg tablet; Drug: Lamivudine 300 mg tablet; Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA); Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB)
Treatment Sequence BCA	Experimental	Subject will receive experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablet (Product Code AA, treatment B) in period 1 and experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablet (Product Code AB, treatment C) in period 2 and reference treatment DTG 50mg and 3TC 300mg administered as single entity tablets (treatment A) in period 3 in a fasted state. There will be at least 7 days washout between dosing periods. Receives: Drug: Dolutegravir 50 mg tablet; Drug: Lamivudine 300 mg tablet; Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA); Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB)
Treatment Sequence CAB	Experimental	Subject will receive experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablets (Product Code AB, treatment C) in period 1 and reference treatment DTG 50mg and 3TC 300mg administered as single entity tablets (treatment A) in period 2 and experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablets (Product Code AA, treatment B) in period 3 in a fasted state. There will be at least 7 days washout between dosing periods. Receives: Drug: Dolutegravir 50 mg tablet; Drug: Lamivudine 300 mg tablet; Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA); Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB)
Treatment Sequence ACB	Experimental	Subject will receive reference treatment DTG 50mg and 3TC 300mg administered as single entity tablets (treatment A) in period 1, experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablets (Product Code AB, treatment C) in period 2 and experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablets (Product Code AA, treatment B) in period 3 in a fasted state. There will be at least 7 days washout between dosing periods. Receives: Drug: Dolutegravir 50 mg tablet; Drug: Lamivudine 300 mg tablet; Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA); Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB)
Treatment Sequence BAC	Experimental	Subject will receive experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablets (Product Code AA, treatment B) in period 1 and reference treatment DTG 50mg and 3TC 300mg administered as single entity tablets (treatment A) in period 2 and experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablets (Product Code AB, treatment C) in period 3 in a fasted state. There will be at least 7 days washout between dosing periods. Receives: Drug: Dolutegravir 50 mg tablet; Drug: Lamivudine 300 mg tablet; Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA); Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB)
Treatment Sequence CBA	Experimental	Subject will receive experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablets (Product Code AB, treatment C) in period 1 and experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablets (Product Code AA, treatment B) in period 2 and reference treatment DTG 50mg and 3TC 300mg administered as single entity tablets (treatment A) in period 3 in a fasted state. There will be at least 7 days washout between dosing periods. Receives: Drug: Dolutegravir 50 mg tablet; Drug: Lamivudine 300 mg tablet; Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA); Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB)

What is being measured

The primary outcome is the main question the study is designed to answer.

DTG: Area under the concentration-time curve from time 0 extrapolated to infinity (AUC[0-inf])
Serial blood samples for pharmacokinetic (PK) analysis of DTG will be collected. From the plasma concentration-time data, the PK parameters will be determined.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
DTG: maximum concentration observed (Cmax)
Serial blood samples for PK analysis of DTG will be collected. From the plasma concentration-time data, the PK parameters will be determined.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
3TC: AUC(0-inf)
Serial blood samples for PK analysis of 3TC will be collected. From the plasma concentration-time data, the PK parameters will be determined.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
3TC: Cmax
Serial blood samples for PK analysis of 3TC will be collected. From the plasma concentration-time data, the PK parameters will be determined.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose

Secondary outcomes (19)

DTG: Area under the concentration-time curve from time 0 to the last measurable timepoint (AUC[0-t])
Serial blood samples for PK analysis of DTG will be collected. From the plasma concentration-time data, the PK parameters will be determined.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
DTG: Drug concentration at 24 hours post-dose (C24)
Serial blood samples for PK analysis of DTG will be collected. From the plasma concentration-time data, the PK parameters will be determined.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
DTG: Half-life (t1/2)
Serial blood samples for PK analysis of DTG will be collected. From the plasma concentration-time data, the PK parameters will be determined.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
DTG: Absorption lag time (tlag)
Serial blood samples for PK analysis of DTG will be collected. From the plasma concentration-time data, the PK parameters will be determined.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
DTG: Time to observed maximal drug concentration (tmax)
Serial blood samples for PK analysis of DTG will be collected. From the plasma concentration-time data, the PK parameters will be determined.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
DTG: Apparent oral clearance (CL/F)
Serial blood samples for PK analysis of DTG will be collected. From the plasma concentration-time data, the PK parameters will be determined.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
3TC:AUC(0-t)
Serial blood samples for PK analysis of 3TC will be collected. From the plasma concentration-time data, the PK parameters will be determined.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
3TC: C24
Serial blood samples for PK analysis of 3TC will be collected. From the plasma concentration-time data, the PK parameters will be determined.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
3TC:t1/2
Serial blood samples for PK analysis of 3TC will be collected. From the plasma concentration-time data, the PK parameters will be determined.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
3TC: tlag
Serial blood samples for PK analysis of 3TC will be collected. From the plasma concentration-time data, the PK parameters will be determined.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
3TC: tmax
Serial blood samples for PK analysis of 3TC will be collected. From the plasma concentration-time data, the PK parameters will be determined.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
3TC: CL/F
Serial blood samples for PK analysis of 3TC will be collected. From the plasma concentration-time data, the PK parameters will be determined.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
Change from baseline in temperature
Measured: Baseline and up to 9 weeks
Change from baseline in systolic and diastolic blood pressure (BP)
Measured: Baseline and up to 9 weeks
Change from baseline in pulse rate
Measured: Baseline and up to 9 weeks
Number of subjects with adverse events
Measured: Up to 9 weeks
Number of subjects with the Toxicity Grade and Change from baseline summary for the Indicated Hematology Parameters
The hematology parameters included are platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), neutrophils, lymphocytes, monocytes, eosinophils, basophils.
Measured: Up to 9 weeks
Number of subjects with the Toxicity Grade and Change from baseline summary for the Indicated Clinical Chemistry Parameters
Clinical chemistry parameters included are blood urea nitrogen (BUN), creatinine, glucose, creatine phosphokinase (CPK), potassium, sodium, calcium, AST, ALT, alkaline phosphatase, total and direct bilirubin, total protein, albumin
Measured: Up to 9 weeks
Number of subjects with urinalysis abnormalities
Urinalysis parameters included are specific gravity, pH, glucose, protein, blood and ketones by dipstick, microscopic examination (if blood or protein is abnormal)
Measured: Up to 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2016Jun 2016

First posted14 Apr 2016 (estimated)
Study startMay 2016
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Infection, Human Immunodeficiency VirusStudies of the same condition, open and under way.
More trials run by ViiV HealthcareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02738931
Sponsor's protocol ID: 204993
Status last verified: Jan 2017
First submitted: 11 Apr 2016
Last updated: 18 Jan 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Relative Oral Bioavailability Study of Different Fixed Dose Combinations of Dolutegravir and Lamivudine in Healthy Subjects
ClinicalTrials.gov ID: NCT02738931
Acronym / sponsor ID: 204993
Conditions: Infection, Human Immunodeficiency Virus
Keywords: dolutegravir, lamivudine, Bioavailability, fixed dose combinations
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: ViiV HealthcareIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: May 2016
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 14 Apr 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Treatment Sequence ABC	Experimental	Drug: Dolutegravir 50 mg tablet, Drug: Lamivudine 300 mg tablet, Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA), Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB)Subject will receive reference treatment DTG 50mg and 3TC 300mg administered as single entity tablets (treatment A) in period 1, experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablet (Product Code AA, treatment B) in period 2 and experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablet (Product Code AB, treatment C) in period 3 in a fasted state. There will be at least 7 days washout between dosing periods.
Treatment Sequence BCA	Experimental	Drug: Dolutegravir 50 mg tablet, Drug: Lamivudine 300 mg tablet, Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA), Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB)Subject will receive experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablet (Product Code AA, treatment B) in period 1 and experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablet (Product Code AB, treatment C) in period 2 and reference treatment DTG 50mg and 3TC 300mg administered as single entity tablets (treatment A) in period 3 in a fasted state. There will be at least 7 days washout between dosing periods.
Treatment Sequence CAB	Experimental	Drug: Dolutegravir 50 mg tablet, Drug: Lamivudine 300 mg tablet, Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA), Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB)Subject will receive experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablets (Product Code AB, treatment C) in period 1 and reference treatment DTG 50mg and 3TC 300mg administered as single entity tablets (treatment A) in period 2 and experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablets (Product Code AA, treatment B) in period 3 in a fasted state. There will be at least 7 days washout between dosing periods.
Treatment Sequence ACB	Experimental	Drug: Dolutegravir 50 mg tablet, Drug: Lamivudine 300 mg tablet, Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA), Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB)Subject will receive reference treatment DTG 50mg and 3TC 300mg administered as single entity tablets (treatment A) in period 1, experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablets (Product Code AB, treatment C) in period 2 and experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablets (Product Code AA, treatment B) in period 3 in a fasted state. There will be at least 7 days washout between dosing periods.
Treatment Sequence BAC	Experimental	Drug: Dolutegravir 50 mg tablet, Drug: Lamivudine 300 mg tablet, Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA), Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB)Subject will receive experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablets (Product Code AA, treatment B) in period 1 and reference treatment DTG 50mg and 3TC 300mg administered as single entity tablets (treatment A) in period 2 and experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablets (Product Code AB, treatment C) in period 3 in a fasted state. There will be at least 7 days washout between dosing periods.
Treatment Sequence CBA	Experimental	Drug: Dolutegravir 50 mg tablet, Drug: Lamivudine 300 mg tablet, Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA), Drug: Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB)Subject will receive experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablets (Product Code AB, treatment C) in period 1 and experimental Dolutegravir/Lamivudine 50 mg/300 mg FDC tablets (Product Code AA, treatment B) in period 2 and reference treatment DTG 50mg and 3TC 300mg administered as single entity tablets (treatment A) in period 3 in a fasted state. There will be at least 7 days washout between dosing periods.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Between 18 and 65 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 evaluation (history, electrocardiogram [ECG]).
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 if required agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Body weight >= 50 kilogram (kg) (110 pounds [lbs.)] for men and >= 45 kg (99 lbs) for women and body mass index (BMI) within the range 18.5-31.0 kg/meter square (m^2) (inclusive)
Male or Female

Key exclusion criteria (15 listed)

Alanine transaminase (ALT) and bilirubin >1.5xupper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
QT interval corrected for heart rate according to Fridericia's formula (QTcF) > 450 millisecond (msec)
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 ViiV/GlaxoSmithKline (GSK) Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
History of regular alcohol consumption within 6 months of the study defined as:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dolutegravir 50 mg tabletA white, film-coated, round tablet debossed with SV 572 on one side and 50 on the other side. Single dose of one tablet will be administered with 240 mL of water.	Drug	Treatment Sequence ABC, Treatment Sequence ACB, Treatment Sequence BAC, Treatment Sequence BCA, Treatment Sequence CAB, Treatment Sequence CBA
Lamivudine 300 mg tabletGray, diamond-shaped tablet, engraved "GX EJ7" on one side and plain on the other side. Single dose of one tablet will be administered with 240 mL of water.	Drug	Treatment Sequence ABC, Treatment Sequence ACB, Treatment Sequence BAC, Treatment Sequence BCA, Treatment Sequence CAB, Treatment Sequence CBA
Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA)Immediate release oval tablet embossed 'gsk' on one face with white film coat. Single dose of one tablet will be administered with 240 mL of water.	Drug	Treatment Sequence ABC, Treatment Sequence ACB, Treatment Sequence BAC, Treatment Sequence BCA, Treatment Sequence CAB, Treatment Sequence CBA
Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB)Immediate release oval tablet embossed 'gsk' on one face with white film coat. Single dose of one tablet will be administered with 240 mL of water.	Drug	Treatment Sequence ABC, Treatment Sequence ACB, Treatment Sequence BAC, Treatment Sequence BCA, Treatment Sequence CAB, Treatment Sequence CBA

Primary outcome

DTG: Area under the concentration-time curve from time 0 extrapolated to infinity (AUC[0-inf])
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
Serial blood samples for pharmacokinetic (PK) analysis of DTG will be collected. From the plasma concentration-time data, the PK parameters will be determined.
DTG: maximum concentration observed (Cmax)
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
Serial blood samples for PK analysis of DTG will be collected. From the plasma concentration-time data, the PK parameters will be determined.
3TC: AUC(0-inf)
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
Serial blood samples for PK analysis of 3TC will be collected. From the plasma concentration-time data, the PK parameters will be determined.
3TC: Cmax
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
Serial blood samples for PK analysis of 3TC will be collected. From the plasma concentration-time data, the PK parameters will be determined.

19 secondary outcomes

DTG: Area under the concentration-time curve from time 0 to the last measurable timepoint (AUC[0-t])
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
DTG: Drug concentration at 24 hours post-dose (C24)
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
DTG: Half-life (t1/2)
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
DTG: Absorption lag time (tlag)
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
DTG: Time to observed maximal drug concentration (tmax)
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
DTG: Apparent oral clearance (CL/F)
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
3TC:AUC(0-t)
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
3TC: C24
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
3TC:t1/2
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
3TC: tlag
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
3TC: tmax
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
3TC: CL/F
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose
Change from baseline in temperature
Time frame: Baseline and up to 9 weeks
Change from baseline in systolic and diastolic blood pressure (BP)
Time frame: Baseline and up to 9 weeks
Change from baseline in pulse rate
Time frame: Baseline and up to 9 weeks
Number of subjects with adverse events
Time frame: Up to 9 weeks
Number of subjects with the Toxicity Grade and Change from baseline summary for the Indicated Hematology Parameters
Time frame: Up to 9 weeks
Number of subjects with the Toxicity Grade and Change from baseline summary for the Indicated Clinical Chemistry Parameters
Time frame: Up to 9 weeks
Number of subjects with urinalysis abnormalities
Time frame: Up to 9 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

ViiV Healthcare

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DTG: Area under the concentration-time curve from time 0 extrapolated to infinity (AUC[0-inf]) (time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 9, 12, 16, 24, and 48 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02738931.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.