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Healthy SubjectsPhase 1NCT00551694

A Second Study to Determine the Effect of GSK256073A on HVTs

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 that have been administrated GSK256073 in the HMA107787 study 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
4 participants
Where
1 siteUnited States
Study dates
Oct 2007to Dec 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 as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, 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 considers that the finding will not introduce additional risk factors and will not interfere with the study procedures
  • Healthy adult males or females between 18 and 55 years of age, inclusive.
  • Female subjects must be of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophorectomy or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy, or documented hysterectomy - tubal ligation is not sufficient
  • Body weight > 50 kg (110 pounds) and body mass index (BMI) between 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 restrictions

Who cannot join

  • Any clinically relevant abnormality identified on the screening medical assessment, laboratory examination or ECG
  • Systolic blood pressure < 100 mmHg or ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg at the screening visit
  • History of significant cardiac arrhythmias.
  • Active peptic ulcer disease (PUD) and/or history of PUD
  • Screening test positive for H. pylori at the screening visit
  • History of gout and/or hyperuricemia
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  • A serum creatinine concentration above the 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) above the normal reference range
  • Positive HIV, Hepatitis B surface antigen or Hepatitis C antibody within 3 months of screening
  • Positive urine drug and alcohol screen at screening or predose on Day 1 of each period
  • History of alcohol consumption exceeding, on average, 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) 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 antimicrobials, proton pump inhibitors and bismuth containing medications within 2 weeks prior to testing for H. pylori at Screening
  • Use of prescription (including hormone replacement therapy) or non-prescription drugs and vitamins within 7 days or 5 half-lives (whichever is longer) prior to administration of study medication. Use of prescription antibiotics within 14 days prior to administration of study medication. An exception is acetaminophen which is allowed at doses of < 2g/day
  • Use of dietary/herbal supplements including (but not limited to) St. John's wort, kava, ephedra (ma huang), gingko biloba, DHEA, yohimbe, saw palmetto, ginseng and red yeast rice within 14 days prior to treatment with study medication
  • The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug(whichever is longer) prior to the first dose of current study medication
  • 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
  • Consumption of grapefruit or grapefruit juice within 7 days prior to the first dose of study medication
  • Donation of blood in excess of 500 mL within 56 days prior to dosing
  • Unwillingness of male subjects to use a condom/spermicide, in addition to having their female partner use another form of contraception, such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation, if engaging in sexual intercourse with a female partner who could become pregnant. This criterion must be followed from the time of the first dose of study medication until 84 days after the last dose of study medication
  • Pregnant or nursing women
  • History of other than rare (once yearly or less) flushing, particularly in perimenopausal women
  • A hemoglobin A1c above the normal reference range and/or fasting blood glucose ≥100 mg/dL at the screening visit
  • History of intra-ocular pathology, including but not limited to retinitis, uveitis, retinal detachment and macular edema

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GSK Investigational Site

    Minneapolis, Minnesota, 55404

Other trials in United States

About this study

Official title: A Second Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single and a Repeat Oral Dose of GSK256073A 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 that have been administrated GSK256073 in the HMA107787 study

Being tested
GSK256073A tablets
Keywords
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 throughout the study.

    Measured: throughout the study.

  2. AUC and Cmax

    Measured: throughout the study

  3. Measures of accumulation ratios throughout the study (Ro, Rp, and Rs)[Period 2]

    Measured: throughout the study

Secondary outcomes (2)

  1. Tmax, t½, Ae, and CLr , Cmax, ss, Ct, t½, Ae, CLr, and accumulation ratios throughout the study

    Measured: throughout the study

  2. PD response: NEFA and TG (6 and 24 hours post- dose), LDL, HDL, ApoA1, ApoA2, Apo B and Lp(a) on Days 1, 14, and 15.

    Measured: 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 posted31 Oct 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionDec 2007
  4. Study completionDec 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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00551694
Sponsor's protocol ID
HMA110541
Status last verified
Feb 2011
First submitted
29 Oct 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 7 inclusion and 28 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 throughout the study. (time frame: throughout the study.). 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 NCT00551694.

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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