AzTrials
AzTrials

Infections, Human Immunodeficiency Virus and HerpesviridaePhase 1NCT01209117

A Study to Assess the Relative Bioavailability of Tablet Formulations of GSK2248761 in Healthy Adult Subjects. SGN114435

A Phase 1 study testing GSK2248761 WBM Capsule, GSK2248761 WBM Tablet Formulation 1 and GSK2248761 WBM Tablet Formulation 2 in people with Infections, Human Immunodeficiency Virus and Herpesviridae and 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
Search all trials

Trial summary

This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects to assess the oral bioavailability of three GSK2248761 Wet Bead Milled (WBM) tablet formulations manufactured by three different processes relative to the GSK2248761 WBM capsule formulation (Part A) and the effect of a… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
What is being tested?
GSK2248761 WBM Capsule, GSK2248761 WBM Tablet Formulation 1 and GSK2248761 WBM Tablet Formulation 2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
Sep 2010to Jan 2011
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 50 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, vital signs, laboratory tests, and ECGs. 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 50 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 (i.e., physiologically incapable of becoming pregnant) including any female who: Is pre-menopausal with a documented bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries) or hysterectomy, or Is post-menopausal defined as 12 months of spontaneous amenorrhea.
  • Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until the follow-up visit.
  • 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).
  • 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.
  • The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
  • Unwilling to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.
  • History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of greater than14 drinks/week for men or greater than 7 drinks/week for women.
  • Unwilling to abstain from alcohol for 48 hours prior to the start of dosing until collection of the final pharmacokinetic sample during each treatment period.
  • History or regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
Show all 22Show fewer
  • History/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or any clinically significant cardiac disease.
  • History/evidence of clinically significant pulmonary disease.
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs. Subjects with a history of cholecystectomy should be excluded.
  • 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).
  • 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. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
  • 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.
  • Note: this does not include plasma donation.
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
  • A positive test for HIV antibody.
  • aspartate aminotransferase (AST), alanine aminotransferase (ALT) , alkaline phosphatase and bilirubin greater than or equal to 1.5 times the Upper limit of normal (isolated bilirubin >1.5 times the upper limit of normal is acceptable if bilirubin is fractionated and direct bilirubin less than 35%).
  • Pregnant females as determined by positive serum pregnancy test at screening or prior to dosing.
  • Lactating females.
  • The subject's systolic blood pressure is outside the range of 90-140 millimeters of mercury, or diastolic blood pressure is outside the range of 45-90millimeters of mercury or heart rate is outside the range of 50-100beats per minute for female subjects or 45-100 beats per minute for male subjects at Screening and predose Day 1.
  • Cardiac conduction abnormalities denoted by any of the following on a single 12-lead ECG at screening or predose Day 1.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GSK Investigational Site

    Buffalo, New York, 14202

Other trials in United States

About this study

Official title: A Single-center, Randomized, Open-label, Crossover Study to Assess the Relative Bioavailability of Tablet Formulations of GSK2248761 in Healthy Adult Subjects. SGN114435

This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects to assess the oral bioavailability of three GSK2248761 Wet Bead Milled (WBM) tablet formulations manufactured by three different processes relative to the GSK2248761 WBM capsule formulation (Part A) and the effect of a moderate-fat meal on the bioavailability of the selected WBM tablet formulation (Part B).

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

Being tested
GSK2248761 WBM Capsule, GSK2248761 WBM Tablet Formulation 1, GSK2248761 WBM Tablet Formulation 2, GSK2248761 WBM Tablet Formulation 3, GSK2248761 WBM Tablet
Keywords
formulation, bioavailability, pharmacokinetics, GSK2248761
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.

  • GSK2248761 WBM CapsuleDrug

    200 mg GSK2248761 WBM capsule (reference) 2 X100mg

  • GSK2248761 WBM Tablet Formulation 1Drug

    GSK2248761 WBM Tablet 200mg manufacturing process 1

  • GSK2248761 WBM Tablet Formulation 2Drug

    GSK2248761 WBM Tablet 200mg manufacturing process 2

  • GSK2248761 WBM Tablet Formulation 3Drug

    GSK2248761 WBM Tablet 200mg manufacturing process 3

  • GSK2248761 WBM TabletDrug

    GSK2248761 WBM tablet 200mg manufacturing process 1, 2, or 3 chosen from Period 1 - 4

Study groups in NCT01209117
Study groupRoleWhat they receive
Periods 1 - 4ExperimentalSubjects will be randomized in a cross over fashion to receive the GSK2248761 WBM capsule formulation or one of three WBM tablet formulations in one of four sequences.
Receives: Drug: GSK2248761 WBM Capsule; Drug: GSK2248761 WBM Tablet Formulation 1; Drug: GSK2248761 WBM Tablet Formulation 2; Drug: GSK2248761 WBM Tablet Formulation 3
Period 5ExperimentalSubjects in Part B will receive a formulation of GSK2248761 200mg WBM Tablet chosen from Periods 1 - 4 in part A in the fed state (moderate fat meal).
Receives: Drug: GSK2248761 WBM Tablet

What is being measured

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

  1. Plasma GSK2248761 Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity))

    Measured: 5 weeks

  2. Plasma GSK2248761 Area under the concentration-time curve over the dosing interval (AUC (0 - t))

    Measured: 5 weeks

  3. Plasma GSK2248761 observed concentration 24 hours after dose (C24)

    Measured: 5 weeks

  4. Plasma GSK2248761 Maximum observed concentration (Cmax)

    Measured: 5 weeks

Secondary outcomes (11)

  1. Safety and tolerability parameters, including adverse events

    Measured: 5 weeks

  2. concurrent medication

    Measured: 5 weeks

  3. Clinical laboratory screens

    Measured: 5 weeks

  4. Electrocardiograms (ECG)

    Measured: 5 weeks

  5. Vital sign assessments (systolic and diastolic blood pressure and pulse)

    Measured: 5 weeks

  6. Plasma GSK2248761 terminal phase half life (t½)

    Measured: 5 weeks

  7. Plasma GSK2248761 Lag time before observation of drug concentrations (tlag)

    Measured: 5 weeks

  8. Plasma GSK2248761 Time of occurrence of Cmax (tmax)

    Measured: 5 weeks

  9. Plasma GSK2248761 Percentage of AUC(0-infinity) obtained by extrapolation (%AUCex)

    Measured: 5 weeks

  10. Plasma GSK2248761 Time of last quantifiable concentration (tlast)

    Measured: 5 weeks

  11. Plasma GSK2248761 Apparent clearance following oral dosing (CL/F)

    Measured: 5 weeks

Timeline

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

  1. First posted27 Sep 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionJan 2011
  4. Study completionJan 2011

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01209117
Sponsor's protocol ID
114435
Status last verified
Jun 2017
First submitted
17 Sep 2010
Last updated
8 Jun 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK2248761 WBM Capsule, GSK2248761 WBM Tablet Formulation 1 and GSK2248761 WBM Tablet Formulation 2 in people with Infections, Human Immunodeficiency Virus and Herpesviridae and 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 6 inclusion and 22 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 8 Jun 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?

Plasma GSK2248761 Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity)) (time frame: 5 weeks). 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 NCT01209117.

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 8 Jun 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in