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Cardiovascular DiseasePhase 1NCT00996268

An Open-label Single Dose Randomized, Parallel Group Study Followed by Single-blind Repeat Dosing, to Compare the Relative Bioavailability of GSK2212836.

A Phase 1 study testing GSK2212836 in people with Cardiovascular Disease, run by GlaxoSmithKline 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

Sixteen healthy subjects will be randomized to each of the 3 parallel treatment groups. Eligible subjects will check in to the clinical unit on Day -2 and have 24-hr pharmacokinetic collections on Day -1 and on Day 1. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Disease
What is being tested?
GSK2212836
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteUnited States
Study dates
15 Oct 2009to 4 Jan 2010
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

  • AST, ALT, alkaline phosphatase and bilirubin less than 1.5xULN (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 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 Child-bearing potential and agrees to use one of the contraception methods listed in the protocol.
  • Body weight greater than or equal to 50kg (110 lbs) for men and greater than or equal to 45 kg for women and BMI within the range 24-34kg/m2 (inclusive).
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Average QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.

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 HIV antibody.
  • History of regular alcohol consumption within 6 months of the study defined as:
  • 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).
Show all 18Show fewer
  • 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.
  • Use of omega-3 fatty acid supplements and/or fish or fish oil products from screening until final assessment and unwilling to abstain from eating oily fish (salmon, albacore tuna, mackerel, sardines, etc.) during the course of the study.
  • 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.
  • History of sensitivity or known allergy to fish and /or shellfish.
  • 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 hCG test at screening (serum) or prior to dosing (urine).
  • 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 abstain from smoking tobacco- or use of nicotine-containing products while in the clinic.

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: An Open-label Single Dose Randomized, Parallel Group Study Followed by Single-blind Repeat Dosing, to Compare the Relative Bioavailability of GSK2212836

Sixteen healthy subjects will be randomized to each of the 3 parallel treatment groups. Eligible subjects will check in to the clinical unit on Day -2 and have 24-hr pharmacokinetic collections on Day -1 and on Day 1. Once the pharmacokinetic parameters of the formulations have been analyzed, doses of GSK2212836 will be selected for further study in Part B. Subjects from Part A will participate in Part B.

Part B is a single blind, randomized, placebo controlled study that will consist of a 2-week repeat dose period with 3 dose levels and one dose of the marketed formulation of GSK2212836. Subjects will check in to the clinical unit on Day -3; will participate in a test meal on Day -2 and have 24-hr baseline pharmacokinetic profiles on Day -1 and Day 1. Subjects will be released from the clinic on Day 2, and return for daily dosing on Days 3 through 12. On Day 6, they will also have a brief outpatient visit. Subjects will check into the clinic again on the evening of Day 12, and on Day 13 they will again have 24-hr pharmacokinetic profiles collected. Subjects will be released from the clinical research unit on Day 14, following a test meal, triglyceride sampling and check-out assessments, and will be released from the study 5-10 days later after completing a follow up visit.

Being tested
GSK2212836
Keywords
hypertriglyceridemia, GSK2212836, relative bioavailability
Medical subject headings
Cardiovascular Diseases, Hypertriglyceridemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK2212836Drug

    Treatment A - GSK2212836 test formulation 1, Treatment B - GSK2212836 test formulation 2, or Treatment C -GSK2212836 marketed formulation.

  • GSK2212836Drug

    Treatment D - low dose of GSK2212836 test formulation, Treatment E - medium dose of GSK2212836 test formulation, Treatment F - high dose of GSK2212836 test formulation, Treatment G - GSK2212836 marketed formulation, or Placebo.

Study groups in NCT00996268
Study groupRoleWhat they receive
Part AExperimentalThree groups of sixteen healthy subjects will be randomized to single doses of 3 different formulations of GSK2212836.
Receives: Drug: GSK2212836
Part BExperimentalFour cohorts of at least 10 subjects will participate in a 2-week repeat dose period with 4 dose levels (based on data obtained in Part A) of the GSK2212836 test formulations or placebo.
Receives: Drug: GSK2212836

What is being measured

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

  1. Part A: To determine the total (AUC(0 to infinity)) and peak (Cmax) exposure of GSK2212836

    Measured: 24 hours

  2. Part B: PK parameters AUC(0-24h) and Cmax following 14 days of dosing with GSK2212836

    Measured: 14 days

  3. Part A: To assess the relative bioavailability of GSK2212836 test capsules vs the reference formulation GSK2213836

    Measured: 24 hours

  4. Part B: To estimate the accumulation and dose proportionality of GSK2212836 after repeat dosing of the test formulation

    Measured: 14 days

Secondary outcomes (4)

  1. Part A: Safety and tolerability parameters following single doses of GSK2212836 test formulation including adverse events, clinical laboratory, ECGs and vital signs assessments.

    Measured: 24 hours

  2. Part A: Secondary PK parameters including: tmax, t1/2 and baseline-corrected AUC(0-24h)

    Measured: 24 hours

  3. Part B: Safety and tolerability parameters following repeat doses of GSK2212836 test formulation including adverse events, clinical laboratory, ECGs and vital signs assessments

    Measured: 14 days

  4. Part B: Secondary PK parameters including: tmax, t1/2

    Measured: 14 days

Timeline

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

  1. First posted16 Oct 2009 (estimated)
  2. Study start15 Oct 2009
  3. Primary completion4 Jan 2010
  4. Study completion4 Jan 2010

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00996268
Sponsor's protocol ID
113412
Status last verified
Jun 2017
First submitted
15 Oct 2009
Last updated
22 Jun 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Hussey EK, Portelli S, Fossler MJ, Gao F, Harris WS, Blum RA, Lates CD, Gould E, Abu-Baker O, Johnson S, Reddy KK. Relative Bioavailability of an Emulsion Formulation for Omega-3-Acid Ethyl Esters Compared to the Commercially Available Formulation: A Randomized, Parallel-Group, Single-Dose Study Followed by Repeat Dosing in Healthy Volunteers. Clin Pharmacol Drug Dev. 2012 Jan;1(1):14-23. doi: 10.1177/2160763X11431107.

    PubMed 27206142

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK2212836 in people with Cardiovascular Disease, run by GlaxoSmithKline 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 7 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 22 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?

Part A: To determine the total (AUC(0 to infinity)) and peak (Cmax) exposure of GSK2212836 (time frame: 24 hours). 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 NCT00996268, which also lists 1 linked publication.

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 22 Jun 2017.

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Clinical Trial NCT00996268 | AzTrials