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Healthy SubjectsPhase 1NCT00488449

Study Of Pharmacokinetics and Pharmacodynamics Effects Of GSK256073A On Healthy Volunteers

A Phase 1 study testing GSK256073A tablets in people with Healthy Subjects and Dyslipidaemias, 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

The purpose of this study is to compare the effects of single and repeat doses of GSK256073 with placebo in HVT subjects. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects, Dyslipidaemias
What is being tested?
GSK256073A tablets
Type of treatment
Pill or oral medicine
How many people
56 participants
Where
1 siteUnited States
Study dates
Jun 2007to Nov 2007
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 Adult males or females between 18 and 55 years of age, inclusive.
  • Female subjects must be of non-childbearing potential
  • Body weight > 50 kg (110 pounds) and body mass index (BMI) 19 and 31 where:
  • Subjects with QTc < 450 msec at screening (or QTc < 480 msec for subjects with Bundle Branch Block).
  • A signed and dated written informed consent prior to admission to the study.
  • The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restriction

Who cannot join

  • Systolic blood pressure < 100 mmHg or 150 mmHg and/or diastolic blood pressure = 100 mmHg at screening.
  • History of significant cardiac arrhythmias
  • Active peptic ulcer disease (PUD) and/or history of PUD within 1 year.
  • A serum uric acid concentration 8mg/dL
  • Screening test positive for H. Pylori using the non-radioactive breath test
  • History of gout and/or hyperuricemia
Show all 35Show fewer
  • History of Gilbert's syndrome
  • A serum creatinine concentration above the normal reference range
  • History of kidney stones
  • PT and/or aPTT above the reference range
  • History of recurrent indigestion, stomach upset or diarrhea
  • Liver function tests (LFTs) or creatinine phosphokinase (CPK) 1.5X ULN
  • Screening stool test positive for occult blood
  • Screening peripheral blood smear with abnormal RBCs
  • CBC, MCV, and/or reticulocyte count corrected for haemoglobin level above the reference range at screening
  • Reduced G6PD activity
  • Serum haptoglobin outside the reference range at screening
  • Total serum LDH > 1.25% above the ULN at screening
  • Positive HIV, Hepatitis B or Hepatitis C at screening
  • The subject has a positive pre-study urine drug/ serum alcohol screen.
  • History of alcohol consumption exceeding, on average, 7 drinks/week for women or 14 drinks/week for men within 6 months of the first dose of study medication or a positive alcohol test at screening
  • History of use of tobacco or nicotine containing products within 6 months of screening or a positive urine cotinine screen
  • Use of prescription (including hormone replacement therapy) or non-prescription drugs and vitamins within 7 days or 5 half-lives prior to administration of study medication. An exception is acetaminophen which is allowed at doses of 2g/day.
  • Use of dietary/herbal supplements within 14 days prior to treatment with study medication
  • Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to dosing.
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • 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 physician responsible, contraindicates their participation.
  • Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period.
  • Unwillingness of male subjects to use a condom/spermicide
  • Pregnant or nursing women.
  • History of flushing (>1 episode annually).
  • Fasting blood glucose 110 mg/dl and/or history of type I or type II DM
  • History of intra-ocular pathology
  • History of recurrent gum bleeding
  • History of bleeding haemorrhoids

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GSK Investigational Site

    Baltimore, Maryland, 21225

Other trials in United States

About this study

Official title: A Two-Part Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Oral Doses of GSK256073A, in a Randomized, Single-Blind, Dose Escalation Study in Healthy Adult Subjects

The purpose of this study is to compare the effects of single and repeat doses of GSK256073 with placebo in HVT subjects.

Being tested
GSK256073A tablets
Keywords
Dose Escalation, GSK256073A,

What participants receive

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

  • GSK256073A tabletsDrug

What is being measured

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

  1. AEs, 12-Lead ECG, vital signs, nursing/physician observation, safety lab tests, flushing

    Measured: throughout the study (Parts A &B)

  2. AUC and Cmax

    Measured: throughout the study (Part A & B)

  3. Measures of accumulation ratios

    Measured: throughout the study (Ro, Rp, and Rs)[Part B]

Secondary outcomes (5)

  1. Tmax, t½, Ae, and CLr (Parts A & B) Cmax, ss, Ct, t½, Ae, CLr, and accumulation ratios (Part B)

    Measured: throughout the study

  2. PD response: NEFA and TG (6 and 24 hours post- dose)

    Measured: (6 and 24 hours post- dose)

  3. LDL, HDL, ApoA1, ApoA2, Apo B and Lp(a)

    Measured: on Days 1, 14, and 15.

  4. Levels of GSK256073 to derive pharmacokinetic parameters following repeat dose administration.

  5. Lipid levels

    Measured: on Days 1, 14, and 15

Timeline

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

  1. First posted20 Jun 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionNov 2007
  4. Study completionNov 2007

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00488449
Sponsor's protocol ID
HMA110015
Status last verified
Feb 2011
First submitted
18 Jun 2007
Last updated
4 Jun 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK256073A tablets in people with Healthy Subjects and Dyslipidaemias, 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 6 inclusion and 35 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 4 Jun 2012. 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?

AEs, 12-Lead ECG, vital signs, nursing/physician observation, safety lab tests, flushing (time frame: throughout the study (Parts A &B)). The study lists 3 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 NCT00488449.

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 4 Jun 2012.

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