Infection, Human Immunodeficiency VirusPhase 1NCT02539576

Pharmacokinetics, Safety and Tolerability Study of Abacavir/ Dolutegravir/ Lamivudine Fixed-dose Combination Tablets in Healthy Japanese Subjects

A Phase 1 study testing ABC/DTG/3TC FDC tablet 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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Infection, Human Immunodeficiency Virus
What is being tested?: ABC/DTG/3TC FDC tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Oct 2015to Nov 2015
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Between 18 and 55 years of age inclusive, at the time of signing the informed consent.
Japanese subjects who were born in Japan with 4 ethnic Japanese grand parents and must not have lived outside Japan for more than 10 years with being a Japanese passport holder (current or expired).
Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, and laboratory tests.
Subject values for haematology and chemistry within the normal range. 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 documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Body weight >=50 kilograms (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 kilogram per meter square (kg/m^2) (inclusive).
Male or female

Show all 12Show fewer

Females- A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum or urine [according to the sites standard of practice] human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies:
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). 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.
Reproductive potential and agrees to follow one of the options listed below in the modified list of highly effective methods for avoiding pregnancy in females of reproductive potential (FRP) from 30 days prior to the first dose of study medication and until 2 weeks after dosing with study medication and completion of the follow-up visit.
The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
Capable of giving signed informed consent as described in the protocol which includes compliance with the requirements and restrictions listed in the consent form and in the protocol.
Documentation that the subject is negative for the human leukocyte antigen (HLA) B*5701 allele.

Who cannot join

Alanine aminotransferase (ALT) >1.5x upper 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).
QTcF >450 millisecond (msec)
NOTES:
The QT duration corrected for heart rate (QTc) is the QTcF machine-read or manually over-read.
The specific formula that will be used to determine eligibility and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to include or discontinue the subject from the trial.

Show all 17Show fewer

For purposes of data analysis, QT interval corrected for heart rate using Bazett's formula (QTcB), QTcF, another QT correction formula, or a composite of available values of QTc will be used as specified in the reporting and analysis plan (RAP).
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 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 unit 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.
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months 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.
Presence of hepatitis B surface antigen (HBsAg), 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
Glendale, California, 91206

Other trials in United States

About this study

Official title: A Phase I, Open-label, Single-dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Abacavir/Dolutegravir/Lamivudine Fixed-dose Combination Tablets in Healthy Japanese Subjects

The abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) 600 milligrams (mg)/50 mg/300 mg fixed-dose combination (FDC) tablet is currently approved in the United States (US) and Europe. Although the pharmacokinetics (PK), safety and tolerability of ABC/DTG/3TC FDC tablets have been extensively studied in subjects not of Japanese heritage, these parameters have not been exclusively assessed in Japanese subjects. To support the marketing application in Japan, this single-dose, open-label study will characterize the PK, safety and tolerability of ABC/DTG/3TC FDC tablet in adult Japanese healthy subjects. A maximum of 12 subjects will be enrolled such that approximately 10 evaluable subjects complete the study. The study will consist of a screening, treatment phase (single oral dose under the fasted state) and follow-up visit (within 7-14 days of the last PK sample collected). The total duration of the study for each subject will be approximately up to 48 days.

Conditions: Infection, Human Immunodeficiency Virus
Being tested: ABC/DTG/3TC FDC tablet
Keywords: pharmacokinetics, Healthy subjects, Abacavir/dolutegravir/lamivudine, Japanese, Fixed-dose combination, safety
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.

ABC/DTG/3TC FDC tabletDrug
ABC/DTG/3TC FDC will be supplied as purple, biconvex, oval tablets debossed with "572 Trı" on one side and plain on the other side. A single dose, with a unit dose strength of 600 mg/50 mg/300 mg will be administered orally.

Study groups in NCT02539576
Study group	Role	What they receive
ABC/DTG/3TC FDC	Experimental	Each subject will receive treatment with a single oral dose of ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablet administered under the fasted state Receives: Drug: ABC/DTG/3TC FDC tablet

What is being measured

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

Area under the concentration-time curve from time zero (pre-dose) to time of last quantifiable concentration (AUC[0-t]) following a single oral dose administration of ABC/DTG/3TC 600 mg/ 50 mg/ 300 mg FDC tablet in healthy, adult Japanese subjects
Blood samples for PK analyses will be collected at pre-dose and 30 minutes, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post- dose.
Measured: Day 1: Pre-dose and at 30 minutes, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 h post dose.
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) following a single oral dose administration of ABC/DTG/3TC 600 mg/ 50 mg/ 300 mg FDC tablet in healthy, adult Japanese subjects
Blood samples for PK analyses will be collected at pre-dose and 30 minutes, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post- dose.
Measured: Day 1: Pre-dose and at 30 minutes, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 h post dose.
Maximum observed plasma concentration (Cmax) following a single oral dose administration of ABC/DTG/3TC 600 mg/ 50 mg/ 300 mg FDC tablet in healthy, adult Japanese subjects
Blood samples for PK analyses will be collected at pre-dose and 30 minutes, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post- dose.
Measured: Day 1: Pre-dose and at 30 minutes, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 h post dose.
Time of occurrence of Cmax (tmax) following a single oral dose administration of ABC/DTG/3TC 600 mg/ 50 mg/ 300 mg FDC tablet in healthy, adult Japanese subjects
Blood samples for PK analyses will be collected at pre-dose and 30 minutes, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post- dose.
Measured: Day 1: Pre-dose and at 30 minutes, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 h post dose.
Concentration at 24 h after dose administration (C24) following a single oral dose administration of ABC/DTG/3TC 600 mg/ 50 mg/ 300 mg FDC tablet in healthy, adult Japanese subjects
Blood samples for PK analyses will be collected at pre-dose and 30 minutes, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post- dose.
Measured: Day 1: Pre-dose and at 30 minutes, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 h post dose.
Terminal phase half-time (t1/2) following a single oral dose administration of ABC/DTG/3TC 600 mg/ 50 mg/ 300 mg FDC tablet in healthy, adult Japanese subjects
Blood samples for PK analyses will be collected at pre-dose and 30 minutes, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post- dose.
Measured: Day 1: Pre-dose and at 30 minutes, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 h post dose.
Apparent clearance following oral dosing (CL/F) following a single oral dose administration of ABC/DTG/3TC 600 mg/ 50 mg/ 300 mg FDC tablet in healthy, adult Japanese subjects
Blood samples for PK analyses will be collected at pre-dose and 30 minutes, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post- dose.
Measured: Day 1: Pre-dose and at 30 minutes, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 h post dose.
Percentage of AUC(0-infinity) obtained by extrapolation (%AUCex) following a single oral dose administration of ABC/DTG/3TC 600 mg/ 50 mg/ 300 mg FDC tablet in healthy, adult Japanese subjects
Blood samples for PK analyses will be collected at pre-dose and 30 minutes, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post- dose.
Measured: Day 1: Pre-dose and at 30 minutes, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 h post dose.
Terminal phase rate constant (Lambda-z) following a single oral dose administration of ABC/DTG/3TC 600 mg/ 50 mg/ 300 mg FDC tablet in healthy, adult Japanese subjects
Blood samples for PK analyses will be collected at pre-dose and 30 minutes, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post- dose.
Measured: Day 1: Pre-dose and at 30 minutes, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 h post dose.

Secondary outcomes (9)

Safety as assessed by the number of subjects with adverse events (AE) and serious adverse events (SAE)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: From Day-1 up to follow-up (approx. Day 18)
Absolute values for composite of clinical chemistry parameters as a safety measure
Clinical chemistry parameters includes blood urea nitrogen, potassium, aspartate aminotransferase, total and direct bilirubin, creatinine, sodium, alanine aminotransferase, total protein, glucose, calcium, alkaline phosphatase and albumin
Measured: Day-1 and follow-up (approx. Day 18)
Change from baseline values for composite of clinical chemistry parameters as a safety measure
Clinical chemistry parameters includes blood urea nitrogen, potassium, aspartate aminotransferase, total and direct bilirubin, creatinine, sodium, alanine aminotransferase, total protein, glucose, calcium, alkaline phosphatase and albumin
Measured: Day-1 and follow-up (approx. Day 18)
Urinalysis assessments
Measured: Day-1 and follow-up (approx. Day 18)
Safety as assessed by systolic and diastolic blood pressure measurements
Measured: Day-1, pre-dose and at 4 h, 24 h, 48 h post-dose, and follow-up (approx. Day 18)
Safety as assessed by pulse rate measurements
Measured: Day-1, pre-dose and at 4 h, 24 h, 48 h post-dose, and follow-up (approx. Day 18)
Safety as assessed by 12-lead electrocardiogram (ECG)
Single 12-lead ECG will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT correction using Fridericia's Formula (QTcF) intervals.
Measured: Day-1 and follow-up (approx. Day 18)
Absolute values for composite of clinical haematology parameters as a safety measure
Clinical haematology parameters includes platelet count, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils
Measured: Day-1 and follow-up (approx. Day 18)
Change from baseline values for composite of clinical haematology parameters as a safety measure
Clinical haematology parameters includes platelet count, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils
Measured: Day-1 and follow-up (approx. Day 18)

Timeline

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

Oct 2015Nov 2015

First posted3 Sep 2015 (estimated)
Study startOct 2015
Primary completionNov 2015
Study completionNov 2015

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02539576
Sponsor's protocol ID: 204662
Status last verified: Dec 2015
First submitted: 20 Aug 2015
Last updated: 21 Dec 2015
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 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open-label, Single-dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Abacavir/Dolutegravir/Lamivudine Fixed-dose Combination Tablets in Healthy Japanese Subjects
ClinicalTrials.gov ID: NCT02539576
Acronym / sponsor ID: 204662
Conditions: Infection, Human Immunodeficiency Virus
Keywords: pharmacokinetics, Healthy subjects, Abacavir/dolutegravir/lamivudine, Japanese, Fixed-dose combination, safety
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: ViiV HealthcareIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: Oct 2015
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 3 Sep 2015 (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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ABC/DTG/3TC FDC	Experimental	Drug: ABC/DTG/3TC FDC tabletEach subject will receive treatment with a single oral dose of ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablet administered under the fasted state

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Between 18 and 55 years of age inclusive, at the time of signing the informed consent.
Japanese subjects who were born in Japan with 4 ethnic Japanese grand parents and must not have lived outside Japan for more than 10 years with being a Japanese passport holder (current or expired).
Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, and laboratory tests.
Subject values for haematology and chemistry within the normal range. 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 documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Body weight >=50 kilograms (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 kilogram per meter square (kg/m^2) (inclusive).

Key exclusion criteria (17 listed)

Alanine aminotransferase (ALT) >1.5x upper 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).
QTcF >450 millisecond (msec)
The QT duration corrected for heart rate (QTc) is the QTcF machine-read or manually over-read.
The specific formula that will be used to determine eligibility and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to include or discontinue the subject from the trial.

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
ABC/DTG/3TC FDC tabletABC/DTG/3TC FDC will be supplied as purple, biconvex, oval tablets debossed with "572 Trı" on one side and plain on the other side. A single dose, with a unit dose strength of 600 mg/50 mg/300 mg will be administered orally.	Drug	ABC/DTG/3TC FDC

Primary outcome

Area under the concentration-time curve from time zero (pre-dose) to time of last quantifiable concentration (AUC[0-t]) following a single oral dose administration of ABC/DTG/3TC 600 mg/ 50 mg/ 300 mg FDC tablet in healthy, adult Japanese subjects
Time frame: Day 1: Pre-dose and at 30 minutes, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 h post dose.
Blood samples for PK analyses will be collected at pre-dose and 30 minutes, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post- dose.
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) following a single oral dose administration of ABC/DTG/3TC 600 mg/ 50 mg/ 300 mg FDC tablet in healthy, adult Japanese subjects
Time frame: Day 1: Pre-dose and at 30 minutes, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 h post dose.
Blood samples for PK analyses will be collected at pre-dose and 30 minutes, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post- dose.
Maximum observed plasma concentration (Cmax) following a single oral dose administration of ABC/DTG/3TC 600 mg/ 50 mg/ 300 mg FDC tablet in healthy, adult Japanese subjects
Time frame: Day 1: Pre-dose and at 30 minutes, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 h post dose.
Blood samples for PK analyses will be collected at pre-dose and 30 minutes, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post- dose.
Time of occurrence of Cmax (tmax) following a single oral dose administration of ABC/DTG/3TC 600 mg/ 50 mg/ 300 mg FDC tablet in healthy, adult Japanese subjects
Time frame: Day 1: Pre-dose and at 30 minutes, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 h post dose.
Blood samples for PK analyses will be collected at pre-dose and 30 minutes, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post- dose.
Concentration at 24 h after dose administration (C24) following a single oral dose administration of ABC/DTG/3TC 600 mg/ 50 mg/ 300 mg FDC tablet in healthy, adult Japanese subjects
Time frame: Day 1: Pre-dose and at 30 minutes, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 h post dose.
Blood samples for PK analyses will be collected at pre-dose and 30 minutes, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post- dose.
Terminal phase half-time (t1/2) following a single oral dose administration of ABC/DTG/3TC 600 mg/ 50 mg/ 300 mg FDC tablet in healthy, adult Japanese subjects
Time frame: Day 1: Pre-dose and at 30 minutes, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 h post dose.
Blood samples for PK analyses will be collected at pre-dose and 30 minutes, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post- dose.
Apparent clearance following oral dosing (CL/F) following a single oral dose administration of ABC/DTG/3TC 600 mg/ 50 mg/ 300 mg FDC tablet in healthy, adult Japanese subjects
Time frame: Day 1: Pre-dose and at 30 minutes, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 h post dose.
Blood samples for PK analyses will be collected at pre-dose and 30 minutes, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post- dose.
Percentage of AUC(0-infinity) obtained by extrapolation (%AUCex) following a single oral dose administration of ABC/DTG/3TC 600 mg/ 50 mg/ 300 mg FDC tablet in healthy, adult Japanese subjects
Time frame: Day 1: Pre-dose and at 30 minutes, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 h post dose.
Blood samples for PK analyses will be collected at pre-dose and 30 minutes, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post- dose.
Terminal phase rate constant (Lambda-z) following a single oral dose administration of ABC/DTG/3TC 600 mg/ 50 mg/ 300 mg FDC tablet in healthy, adult Japanese subjects
Time frame: Day 1: Pre-dose and at 30 minutes, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 h post dose.
Blood samples for PK analyses will be collected at pre-dose and 30 minutes, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post- dose.

9 secondary outcomes

Safety as assessed by the number of subjects with adverse events (AE) and serious adverse events (SAE)
Time frame: From Day-1 up to follow-up (approx. Day 18)
Absolute values for composite of clinical chemistry parameters as a safety measure
Time frame: Day-1 and follow-up (approx. Day 18)
Change from baseline values for composite of clinical chemistry parameters as a safety measure
Time frame: Day-1 and follow-up (approx. Day 18)
Urinalysis assessments
Time frame: Day-1 and follow-up (approx. Day 18)
Safety as assessed by systolic and diastolic blood pressure measurements
Time frame: Day-1, pre-dose and at 4 h, 24 h, 48 h post-dose, and follow-up (approx. Day 18)
Safety as assessed by pulse rate measurements
Time frame: Day-1, pre-dose and at 4 h, 24 h, 48 h post-dose, and follow-up (approx. Day 18)
Safety as assessed by 12-lead electrocardiogram (ECG)
Time frame: Day-1 and follow-up (approx. Day 18)
Absolute values for composite of clinical haematology parameters as a safety measure
Time frame: Day-1 and follow-up (approx. Day 18)
Change from baseline values for composite of clinical haematology parameters as a safety measure
Time frame: Day-1 and follow-up (approx. Day 18)

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 21 Dec 2015.

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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?

A Phase 1 study testing ABC/DTG/3TC FDC tablet in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 1 site in United States.

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 12 inclusion and 17 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 21 Dec 2015. 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?

Area under the concentration-time curve from time zero (pre-dose) to time of last quantifiable concentration (AUC[0-t]) following a single oral dose administration of ABC/DTG/3TC 600 mg/ 50 mg/ 300 mg FDC tablet in healthy, adult Japanese subjects (time frame: Day 1: Pre-dose and at 30 minutes, 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 12 h, 16 h, 24 h, 36 h, 48 h and 72 h post dose.). The study lists 9 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 NCT02539576.

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 21 Dec 2015.