Infections, Human Immunodeficiency Virus and HepatitisPhase 1NCT01648257
Relative Bioavailability Study of GSK1265744 Formulations
A Phase 1 study testing GSK1265744 Na Salt Tablets, GSK1265744 Free Acid Nanomilled Capsules and GSK1265744 Free Acid Micronized Capsules in people with Infections, Human Immunodeficiency Virus and Hepatitis, run by ViiV Healthcare at 1 site in United States.
Trial summary
This is a single-center, randomized, open-label, balanced, 3 way crossover study (3 periods) in healthy adult subjects. During each period, subjects will receive a single dose of GSK1265744 oral formulation in the fasted state and serial PK sampling for up to 168 hours (8 days) and safety assessments will be… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Human Immunodeficiency Virus and Hepatitis
- What is being tested?
- GSK1265744 Na Salt Tablets, GSK1265744 Free Acid Nanomilled Capsules and GSK1265744 Free Acid Micronized Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Nov 2012
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Alanine aminotransferase (ALT), 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%).
- 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 clinically significant abnormality or laboratory parameter outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male or female between 18 and 64 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 salpingo-oophorectomy or hysterectomy; postmenopausal defined in the protocol; or child-bearing potential and agrees to use one of the contraception methods listed in the protocol.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods. 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.
- Body weight >= 50 kilogram (kg) for men and >= 45 kg for women and body mass index (BMI) within the range 18.5 to 31.0 kg/ (meters squared) m^2 (inclusive).
Who cannot join
- 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).
- A positive pre-study drug/alcohol screen.
- A positive test for human immunodeficiency virus (HIV) antibody.
- History of regular alcohol consumption within 6 months of the study.
- 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).
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- Exposure to more than four new investigational chemical entities within 12 months prior to the first dosing day.
- 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.
- 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 GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Pregnant females as determined by positive urine human chorionic gonadotropin (hCG) test at screening or prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Unable to refrain from consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
- The subject's systolic blood pressure is outside the range of 90-140 millimeters of mercury (mmHg), or diastolic blood pressure is outside the range of 45 to 90 mmHg.
- History of clinically significant cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Overland Park, Kansas, 66211
About this study
Official title: A Single-center, Randomized, Open-label, Crossover Study to Assess the Relative Bioavailability of New Formulations of GSK1265744 in Healthy Adult Subjects
This is a single-center, randomized, open-label, balanced, 3 way crossover study (3 periods) in healthy adult subjects. During each period, subjects will receive a single dose of GSK1265744 oral formulation in the fasted state and serial PK sampling for up to 168 hours (8 days) and safety assessments will be performed. Each period will be separated by a washout period of at least 14 days and a follow-up visit will occur 10 to 14 days after the last dose of study drug.
- Being tested
- GSK1265744 Na Salt Tablets, GSK1265744 Free Acid Nanomilled Capsules, GSK1265744 Free Acid Micronized Capsules
- Keywords
- healthy subjects, relative bioavailability, HIV, GSK1265744
- Medical subject headings
- Infections, Acquired Immunodeficiency Syndrome, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1265744 Na Salt TabletsDrug
Each tablet contains 30 mg of GSK1265744 sodium salt and excipients.
GSK1265744 Free Acid Nanomilled CapsulesDrug
Each capsule contains 30 mg of nanomilled and spray dried GSK1265744 free acid, blended with excipients.
GSK1265744 Free Acid Micronized CapsulesDrug
Each capsule contains 30 mg of micronized GSK1265744 free acid, blended with excipients.
| Study group | Role | What they receive |
|---|---|---|
| GSK1265744 Na Salt Tablets | Experimental | Subjects will receive single dose of GSK1265744 sodium salt (30 mg) tablet on Day 1 of the respective period per randomized sequence, orally in fasted condition, with 240 milliliter (mL) of water. Receives: Drug: GSK1265744 Na Salt Tablets |
| GSK1265744 Free Acid Nanomilled Capsules | Experimental | Subjects will receive single dose of GSK1265744 free acid nanomilled (30 mg) capsule on Day 1 of the respective period per randomized sequence, orally in fasted condition, with 240 mL of water. Receives: Drug: GSK1265744 Free Acid Nanomilled Capsules |
| GSK1265744 Free Acid Micronized Capsules | Experimental | Subjects will receive single dose of GSK1265744 free acid micronized (30 mg) capsule on Day 1 of the respective period per randomized sequence, orally in fasted condition, with 240 mL of water. Receives: Drug: GSK1265744 Free Acid Micronized Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of PK parameters following single oral dose administration of GSK1265744
Plasma GSK1265744 PK parameters: area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time AUC(0-infinity); AUC from time zero to time t, AUC(0-t), and maximum observed concentration, Cmax.
Measured: For 168 hours post dose (36 days)
Secondary outcomes (6)
Composite of PK parameters following single oral dose administration of GSK1265744
Following plasma GSK1265744 PK parameters will be evaluated: concentration at 24 hour post-dose (C24), terminal phase half-life (t1/2), lag time before observation of drug concentrations in sampled matrix (tlag), time of occurrence of Cmax (tmax), percentage of AUC(0-infinity) obtained by extrapolation (%AUCex), apparent clearance following oral dosing (CL/F).
Measured: For 168 hours post each dose of GSK1265744 (36 days)
Safety and tolerability as assessed by the collection of adverse events
Measured: 50 days
Safety and tolerability as assessed by change from baseline in clinical laboratory tests
Clinical laboratory tests include hematology, clinical chemistry, urinalysis tests.
Measured: 50 days
Safety and tolerability as assessed by change from baseline in electrocardiogram (ECG)
Measured: 50 days
Safety and tolerability as assessed by change from baseline in vital signs
Vital sign measurements will include systolic and diastolic blood pressure and pulse rate.
Measured: 50 days
Safety and tolerability as assessed by the collection of concurrent medication.
Measured: 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, Human Immunodeficiency Virus and HepatitisStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648257
- Sponsor's protocol ID
- 116585
- Status last verified
- Aug 2016
- First submitted
- 19 Jul 2012
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Open-label, Crossover Study to Assess the Relative Bioavailability of New Formulations of GSK1265744 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01648257
- Acronym / sponsor ID
- 116585
- Keywords
- healthy subjects, relative bioavailability, HIV, GSK1265744
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 24 Jul 2012 (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.
This is a single-center, randomized, open-label, balanced, 3 way crossover study (3 periods) in healthy adult subjects. During each period, subjects will receive a single dose of GSK1265744 oral formulation in the fasted state and serial PK sampling for up to 168 hours (8 days) and safety assessments will be performed. Each period will be separated by a washout period of at least 14 days and a follow-up visit will occur 10 to 14 days after the last dose of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GSK1265744 Na Salt Tablets | Experimental | Drug: GSK1265744 Na Salt TabletsSubjects will receive single dose of GSK1265744 sodium salt (30 mg) tablet on Day 1 of the respective period per randomized sequence, orally in fasted condition, with 240 milliliter (mL) of water. |
| GSK1265744 Free Acid Nanomilled Capsules | Experimental | Drug: GSK1265744 Free Acid Nanomilled CapsulesSubjects will receive single dose of GSK1265744 free acid nanomilled (30 mg) capsule on Day 1 of the respective period per randomized sequence, orally in fasted condition, with 240 mL of water. |
| GSK1265744 Free Acid Micronized Capsules | Experimental | Drug: GSK1265744 Free Acid Micronized CapsulesSubjects will receive single dose of GSK1265744 free acid micronized (30 mg) capsule on Day 1 of the respective period per randomized sequence, orally in fasted condition, with 240 mL of water. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Alanine aminotransferase (ALT), 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%).
- 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 clinically significant abnormality or laboratory parameter outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male or female between 18 and 64 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 salpingo-oophorectomy or hysterectomy; postmenopausal defined in the protocol; or child-bearing potential and agrees to use one of the contraception methods listed in the protocol.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods. 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.
Key exclusion criteria (18 listed)
- 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).
- A positive pre-study drug/alcohol screen.
- A positive test for human immunodeficiency virus (HIV) antibody.
- History of regular alcohol consumption within 6 months of the study.
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 |
|---|---|---|
| GSK1265744 Na Salt TabletsEach tablet contains 30 mg of GSK1265744 sodium salt and excipients. | Drug | GSK1265744 Na Salt Tablets |
| GSK1265744 Free Acid Nanomilled CapsulesEach capsule contains 30 mg of nanomilled and spray dried GSK1265744 free acid, blended with excipients. | Drug | GSK1265744 Free Acid Nanomilled Capsules |
| GSK1265744 Free Acid Micronized CapsulesEach capsule contains 30 mg of micronized GSK1265744 free acid, blended with excipients. | Drug | GSK1265744 Free Acid Micronized Capsules |
Primary outcome
Composite of PK parameters following single oral dose administration of GSK1265744
Time frame: For 168 hours post dose (36 days)
Plasma GSK1265744 PK parameters: area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time AUC(0-infinity); AUC from time zero to time t, AUC(0-t), and maximum observed concentration, Cmax.
6 secondary outcomes
Composite of PK parameters following single oral dose administration of GSK1265744
Time frame: For 168 hours post each dose of GSK1265744 (36 days)
Safety and tolerability as assessed by the collection of adverse events
Time frame: 50 days
Safety and tolerability as assessed by change from baseline in clinical laboratory tests
Time frame: 50 days
Safety and tolerability as assessed by change from baseline in electrocardiogram (ECG)
Time frame: 50 days
Safety and tolerability as assessed by change from baseline in vital signs
Time frame: 50 days
Safety and tolerability as assessed by the collection of concurrent medication.
Time frame: 50 days
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 12 Aug 2016.
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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 GSK1265744 Na Salt Tablets, GSK1265744 Free Acid Nanomilled Capsules and GSK1265744 Free Acid Micronized Capsules in people with Infections, Human Immunodeficiency Virus and Hepatitis, 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 6 inclusion and 18 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 12 Aug 2016. 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?
Composite of PK parameters following single oral dose administration of GSK1265744 (time frame: For 168 hours post dose (36 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2016; AzTrials last refreshed its copy on 6 Nov 2026.