CompletedPhase 1

An Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK1265744 Administered as a Single Oral Dose and a Study to Describe the Pharmacokinetics of a Supratherapeutic Dose of GSK1265744 in Healthy Adult Subjects

United States16 participantsStarted 2013-05

Plain-language summary

This will be a two-part study in healthy adults. Part A is a phase 1, non-randomized, open label, single-dose, single-centre mass balance study utilizing a radiolabeled dose to investigate the recovery, excretion, and pharmacokinetics of oral GSK1265744 in a cohort of 6 healthy adult male subjects. Subjects will undergo a pre-study screening visit within 30 days of the first dose and those who successfully pass pre-study assessments and meet eligibility criteria will be enrolled into the study to receive the equivalent of a 30 mg dose of GSK1265744 as an oral solution, containing approximately 70 microcuries (mcg Ci) \[0.96 millisieverts (mSv)\] of radioactivity under fasted conditions. Blood, urine and fecal samples will be collected for a maximum of 504 hours (21 days) following study drug administration. In Part B, approximately 10 healthy male and female subjects will be enrolled to evaluate the single-dose safety, tolerability and PK of supratherapeutic dose of GSK1265744 150 mg compared with placebo. Each subject will receive a single dose of GSK1265744 150 mg or placebo on Day 1 under fasting conditions in the morning. Blood, urine and fecal samples will be collected for 336 hours (14 days) following dosing.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. * Part A: Male subjects between 30 and 55 years of age at the time of signing the informed consent. * Part B: Male or female between 18 and 60 years of age inclusive, at the time of signing the informed consent. * Parts A and B male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in protocol. This criterion must be followed from the time of the first dose of study medication until 14 days after the last dose of study medication. * Part B: 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 salpingo-oophorectomy or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. Woman with child-bearing potential and is abstinent or agrees to use one of the contraception methods listed in protocol for an appropriate period of time prior to the start of dosing. Female subjects must agree to use contraception until 14 days after the last dose of study medication * Alanine aminotransferase (ALT), alkaline phosphatase (ALP) and bilirubin \<= 1.5xUpper limit of normal (ULN) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%) * Body weight \>= 50 kilogram …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part A: Percent recovery of total radioactive [14C] GSK1265744 in urine and feces.

Timeframe: Up to 21 days

Part A: Composite of plasma GSK1265744 PK parameters to access total radioactivity in blood

Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 288, 312 and 336 hours post dose.

Part B: Number of participants with the use of concurrent medication as a measure of safety and tolerability

Timeframe: Up to 14 days

Part B: Absolute values and changes over time of hematology as a measure of safety and tolerability.

Timeframe: Up to 14 days

Part B: Absolute values and changes over time of clinical chemistry as a measure of safety and tolerability.

Timeframe: Up to 14 days

Part B: Absolute values and changes over time of urinalysis as a measure of safety and tolerability.

Timeframe: Up to 14 days

Trial details

NCT IDNCT01848340

SponsorViiV Healthcare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-07

View on ClinicalTrials.gov More HIV-associated Lipodystrophy Syndrome trials

Plain-language summary

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part A: Percent recovery of total radioactive [14C] GSK1265744 in urine and feces.

Timeframe: Up to 21 days

Part A: Composite of plasma GSK1265744 PK parameters to access total radioactivity in blood

Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 288, 312 and 336 hours post dose.

Part B: Number of participants with the use of concurrent medication as a measure of safety and tolerability

Timeframe: Up to 14 days

Part B: Absolute values and changes over time of hematology as a measure of safety and tolerability.

Timeframe: Up to 14 days

Part B: Absolute values and changes over time of clinical chemistry as a measure of safety and tolerability.

Timeframe: Up to 14 days

Part B: Absolute values and changes over time of urinalysis as a measure of safety and tolerability.

Timeframe: Up to 14 days