Infections, Human Immunodeficiency Virus and HerpesviridaePhase 1NCT01756131

A Single Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Intramuscular and Subcutaneous Long Acting GSK1265744 in Healthy Subjects

A Phase 1 study testing GSK1265744 injectable suspension in people with Infections, Human Immunodeficiency Virus and Herpesviridae, run by ViiV Healthcare.

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: Infections, Human Immunodeficiency Virus and Herpesviridae
What is being tested?: GSK1265744 injectable suspension
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 72 participants
Where: No sites listed yet
Study dates: Sep 2010to Dec 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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters 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 55 years of age inclusive, at the time of signing the informed consent.
Females of childbearing potential with a negative pregnancy test (serum or urine) at screen and at Day -1, and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until the investigational product is undetectable.
Body weight greater than or equal to 50 kilograms (kg) for men and greater than or equal to 45 kg for women and body mass index (BMI) within the range 18.5-31.0 kilograms per meters squared (inclusive).
Average QTcB or QTcF less than 450 milliseconds (msec); or QTc less than 480 msec in subjects with Bundle Branch Block.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

Who cannot join

As a result of the medical interview, physical examination, or screening investigations, the Investigator considers the subject unfit for the study.
A positive pre-study Hepatitis B surface antigen, positive Hepatitis C antibody, or positive test for HIV antibody result within 3 months of screening
High-risk behavior for Human Immunodeficiency Virus (HIV) infection including one of the following risk factors within six months before entering the study (day 1): Unprotected vaginal or anal sex with a known HIV infected person or a casual partner, engaged in sex work for money or drugs, acquired a sexually transmitted disease, high risk partner currently or in the previous six months.
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.
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.

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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. If heparin is used during pharmacokinetics sampling, subjects with a history or sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
A positive pre-study drug screen.
History of regular alcohol consumption within 6 months of the study defined as:
An average weekly intake of greater than 14 drinks for males or greater than 7 drinks for females.
Unwilling to abstain from alcohol from 48 hours prior to admission to study site (Day -1) until discharge from clinic and for 48 hours prior to drawing clinical laboratory tests (Day 7, Day 14, Week 3, Week 4, Week 6, Week 8, Week 12, and follow-up [if necessary]).
Where participation in the study would result in donation of blood or blood products in excess of 500 milliliters (mL) within a 56 day period
Lactating females.
The subject has an underlying skin disease or disorder (i.e. infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria).
The subject has a tattoo or other dermatological condition overlying the gluteus and/or abdominal region which may interfere with interpretation of injection site reactions.
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, and direct bilirubin values above 1.5 times the upper limit of normal (isolated bilirubin greater than 1.5 times the upper limit of normal is acceptable if bilirubin is fractionated and direct bilirubin less than 35%).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
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 45-90mmHg or heart rate is outside the range of 50-100 beats per minute (bpm) for female subjects or 45-100 bpm for male subjects.
History of clinically significant cardiovascular disease

About this study

Official title: An Observer- and Subject-Blinded, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Intramuscular and Subcutaneous Long Acting GSK1265744 in Healthy Subjects

A single dose escalation study to determine the safety, tolerability, and pharmacokinetic profile of intramuscular and subcutaneous injections of GSK1265744 long acting parenteral (LAP) in healthy subjects. This study consists of a screening visit, a single injection, and follow-up evaluations for a minimum of 12 weeks following the injection.

Read the detailed description

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship

Conditions: Infections, Human Immunodeficiency Virus and Herpesviridae
Being tested: GSK1265744 injectable suspension, Placebo to match injectable suspension
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.

GSK1265744 injectable suspensionDrug
200 milligram per milliliter sterile solution for injection
Placebo to match injectable suspensionOther
placebo

Study groups in NCT01756131
Study group	Role	What they receive
Cohort 1	Experimental	100 mg GSK1265744 injectable suspension or placebo, intramuscular dosing Receives: Drug: GSK1265744 injectable suspension; Other: Placebo to match injectable suspension
Cohort 2	Experimental	200 mg GSK1265744 injectable suspension or placebo, intramuscular dosing Receives: Drug: GSK1265744 injectable suspension; Other: Placebo to match injectable suspension
Cohort 3	Experimental	400 mg GSK1265744 injectable suspension or placebo, intramuscular dosing Receives: Drug: GSK1265744 injectable suspension; Other: Placebo to match injectable suspension
Cohort 4	Experimental	800 mg GSK1265744 injectable suspension or placebo, intramuscular dosing Receives: Drug: GSK1265744 injectable suspension; Other: Placebo to match injectable suspension
Cohort 5	Experimental	100 mg GSK1265744 injectable suspension or placebo, subcutaneous dosing Receives: Other: Placebo to match injectable suspension
Cohort 6	Experimental	200 mg GSK1265744 injectable suspension or placebo, subcutaneous dosing Receives: Other: Placebo to match injectable suspension
Cohort 7	Experimental	400 mg GSK1265744 injectable suspension or placebo, subcutaneous dosing Receives: Drug: GSK1265744 injectable suspension
Cohort 8	Experimental	400 mg GSK1265744 injectable suspension or placebo, intramuscular dosing Receives: Drug: GSK1265744 injectable suspension
Cohort 9	Experimental	400 mg GSK1265744 injectable suspension or placebo, intramuscular dosing Receives: Drug: GSK1265744 injectable suspension

What is being measured

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

GSK1265744 safety and tolerability parameters including: the collection of adverse events
Measured: 12 weeks
Change from baseline values in clinical laboratory assessments
Measured: 12 weeks
Change from baseline for Electrocardiogram (ECG) assessments
Measured: 12 weeks
Change from baseline valuse in vital sign assessments (systolic and diastolic blood pressure and pulse rate)
Measured: 12 weeks
Composite of pharmacokinetic parameters: pre-dose and at 4, 8, 12 hours, Day 2, Days 3, 4, 5, 6, 7, Weeks 3, 4, 5, 6, 8, 12 and every 4 weeks until GSK1265744 is less than 0.10 or until 24 weeks
GSK1265744 pharmacokinetic parameters: area under the plasma concentration time curve from time zero to the last quantifiable time points (AUC(0-tau)), area under the plasma concentration time curve from time zero to infinity (AUC(0-infinity)), maximum observed concentration (Cmax), time to maximum observed concentration (tmax), apparent terminal phase half-life for LAP administration (t½), lambda z as a measure of absorption rate constant
Measured: 12 weeks
GSK1265744 concentration at 1 month post-dose (C720 hours)
Measured: 4 weeks

Secondary outcomes (4)

Composite of pharmacokinetic parameters: pre-dose and at 4, 8, 12 hours, Day 2, Days 3, 4, 5, 6, 7, Weeks 3, 4, 5, 6, 8, 12 and every 4 weeks until GSK1265744 is less than 0.10 or until 24 weeks.
GSK1265744 pharmacokinetic parameters: absorption lag time (tlag), apparent clearance (CL/F,LAP) following single dose administration, Percentage of AUC(0-infinity) obtained by extrapolation (AUC%ex)
Measured: 12 weeks
Composite of pharmacokinetic parameters for dose proportionality: pre-dose and at 4, 8, 12 hours, Day 2, Days 3, 4, 5, 6, 7, Weeks 3, 4, 5, 6, 8, 12 and every 4 weeks until GSK1265744 is less than 0.10 or until 24 weeks
GSK1265744 following single dose administration at different doses for the assessment of dose proportionality: AUC(0-infinity), AUC(0-tau), Cmax
Measured: 12 weeks
GSK1265744 C720 hours following single dose administration at different doses for the assessment of dose proportionality
Measured: 12 weeks
GSK1265744 concentrations in cervicovaginal fluid (CVF), cervical tissue (CT), vaginal tissue (VT), rectal tissue (RT), and blood plasma and ratio of CVF, CT, VT, and RT concentration to blood plasma
Cohort 8 at week 2 and week 8; Cohort 9 at week 4 and week 12
Measured: Cohort 8 at week 2 and week 8; Cohort 9 at week 4 and week 12

Timeline

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

Sep 2010Dec 2012

First posted25 Dec 2012 (estimated)
Study startSep 2010
Primary completionDec 2012
Study completionDec 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 HerpesviridaeStudies 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
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Investigator
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01756131
Sponsor's protocol ID: 114433
Status last verified: Mar 2013
First submitted: 1 Sep 2011
Last updated: 20 May 2013
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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 20 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observer- and Subject-Blinded, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Intramuscular and Subcutaneous Long Acting GSK1265744 in Healthy Subjects
ClinicalTrials.gov ID: NCT01756131
Acronym / sponsor ID: 114433
Conditions: Infections, Human Immunodeficiency Virus and Herpesviridae
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: ViiV HealthcareIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: Sep 2010
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 25 Dec 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.

Detailed description

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship

Study design

Allocation: Randomised
Intervention model: Single group
Masking: Single blind (investigator)
Number of arms: 9

Arm	Type	Receives
Cohort 1	Experimental	Drug: GSK1265744 injectable suspension, Other: Placebo to match injectable suspension100 mg GSK1265744 injectable suspension or placebo, intramuscular dosing
Cohort 2	Experimental	Drug: GSK1265744 injectable suspension, Other: Placebo to match injectable suspension200 mg GSK1265744 injectable suspension or placebo, intramuscular dosing
Cohort 3	Experimental	Drug: GSK1265744 injectable suspension, Other: Placebo to match injectable suspension400 mg GSK1265744 injectable suspension or placebo, intramuscular dosing
Cohort 4	Experimental	Drug: GSK1265744 injectable suspension, Other: Placebo to match injectable suspension800 mg GSK1265744 injectable suspension or placebo, intramuscular dosing
Cohort 5	Experimental	Other: Placebo to match injectable suspension100 mg GSK1265744 injectable suspension or placebo, subcutaneous dosing
Cohort 6	Experimental	Other: Placebo to match injectable suspension200 mg GSK1265744 injectable suspension or placebo, subcutaneous dosing
Cohort 7	Experimental	Drug: GSK1265744 injectable suspension400 mg GSK1265744 injectable suspension or placebo, subcutaneous dosing
Cohort 8	Experimental	Drug: GSK1265744 injectable suspension400 mg GSK1265744 injectable suspension or placebo, intramuscular dosing
Cohort 9	Experimental	Drug: GSK1265744 injectable suspension400 mg GSK1265744 injectable suspension or placebo, intramuscular dosing

Who may qualify

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

Key inclusion criteria (6 listed)

Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters 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 55 years of age inclusive, at the time of signing the informed consent.
Females of childbearing potential with a negative pregnancy test (serum or urine) at screen and at Day -1, and agrees to use one of the contraception methods listed in the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until the investigational product is undetectable.
Body weight greater than or equal to 50 kilograms (kg) for men and greater than or equal to 45 kg for women and body mass index (BMI) within the range 18.5-31.0 kilograms per meters squared (inclusive).
Average QTcB or QTcF less than 450 milliseconds (msec); or QTc less than 480 msec in subjects with Bundle Branch Block.

Key exclusion criteria (19 listed)

As a result of the medical interview, physical examination, or screening investigations, the Investigator considers the subject unfit for the study.
A positive pre-study Hepatitis B surface antigen, positive Hepatitis C antibody, or positive test for HIV antibody result within 3 months of screening
High-risk behavior for Human Immunodeficiency Virus (HIV) infection including one of the following risk factors within six months before entering the study (day 1): Unprotected vaginal or anal sex with a known HIV infected person or a casual partner, engaged in sex work for money or drugs, acquired a sexually transmitted disease, high risk partner currently or in the previous six months.
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.

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 injectable suspension200 milligram per milliliter sterile solution for injection	Drug	Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 7, Cohort 8, Cohort 9
Placebo to match injectable suspensionplacebo	Other	Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6

Primary outcome

GSK1265744 safety and tolerability parameters including: the collection of adverse events
Time frame: 12 weeks
Change from baseline values in clinical laboratory assessments
Time frame: 12 weeks
Change from baseline for Electrocardiogram (ECG) assessments
Time frame: 12 weeks
Change from baseline valuse in vital sign assessments (systolic and diastolic blood pressure and pulse rate)
Time frame: 12 weeks
Composite of pharmacokinetic parameters: pre-dose and at 4, 8, 12 hours, Day 2, Days 3, 4, 5, 6, 7, Weeks 3, 4, 5, 6, 8, 12 and every 4 weeks until GSK1265744 is less than 0.10 or until 24 weeks
Time frame: 12 weeks
GSK1265744 pharmacokinetic parameters: area under the plasma concentration time curve from time zero to the last quantifiable time points (AUC(0-tau)), area under the plasma concentration time curve from time zero to infinity (AUC(0-infinity)), maximum observed concentration (Cmax), time to maximum observed concentration (tmax), apparent terminal phase half-life for LAP administration (t½), lambda z as a measure of absorption rate constant
GSK1265744 concentration at 1 month post-dose (C720 hours)
Time frame: 4 weeks

4 secondary outcomes

Composite of pharmacokinetic parameters: pre-dose and at 4, 8, 12 hours, Day 2, Days 3, 4, 5, 6, 7, Weeks 3, 4, 5, 6, 8, 12 and every 4 weeks until GSK1265744 is less than 0.10 or until 24 weeks.
Time frame: 12 weeks
Composite of pharmacokinetic parameters for dose proportionality: pre-dose and at 4, 8, 12 hours, Day 2, Days 3, 4, 5, 6, 7, Weeks 3, 4, 5, 6, 8, 12 and every 4 weeks until GSK1265744 is less than 0.10 or until 24 weeks
Time frame: 12 weeks
GSK1265744 C720 hours following single dose administration at different doses for the assessment of dose proportionality
Time frame: 12 weeks
GSK1265744 concentrations in cervicovaginal fluid (CVF), cervical tissue (CT), vaginal tissue (VT), rectal tissue (RT), and blood plasma and ratio of CVF, CT, VT, and RT concentration to blood plasma
Time frame: Cohort 8 at week 2 and week 8; Cohort 9 at week 4 and week 12

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 20 May 2013.

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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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK1265744 injectable suspension in people with Infections, Human Immunodeficiency Virus and Herpesviridae, run by ViiV Healthcare.

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 19 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 20 May 2013. Status can change between updates, so confirm with the study contact before making plans.

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?

GSK1265744 safety and tolerability parameters including: the collection of adverse events (time frame: 12 weeks). The study lists 6 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 NCT01756131.

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 20 May 2013.