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Study Of Pharmacokinetics and Pharmacodynamics Effects Of GSK256073A On Healthy Volunteers

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00488449
Collaborator
(none)
56
Enrollment
1
Location
5
Duration (Months)
11.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: GSK256073A tablets
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single
Primary Purpose:
Diagnostic
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
Study Start Date :
Jun 1, 2007
Actual Primary Completion Date :
Nov 1, 2007
Actual Study Completion Date :
Nov 1, 2007

Outcome Measures

Primary Outcome Measures

  1. AEs, 12-Lead ECG, vital signs, nursing/physician observation, safety lab tests, flushing [throughout the study (Parts A &B)]

  2. AUC and Cmax [throughout the study (Part A & B)]

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

Secondary Outcome Measures

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

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

  3. LDL, HDL, ApoA1, ApoA2, Apo B and Lp(a) [on Days 1, 14, and 15.]

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

  5. Lipid levels [on Days 1, 14, and 15]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion criteria:

  • 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

Exclusion criteria:

  • 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

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Baltimore Maryland United States 21225

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00488449
Other Study ID Numbers:
  • HMA110015
First Posted:
Jun 20, 2007
Last Update Posted:
Jun 4, 2012
Last Verified:
Feb 1, 2011
Keywords provided by GlaxoSmithKline
Dose Escalation
GSK256073A,
Additional relevant MeSH terms:
Dyslipidemias

Study Results

No Results Posted as of Jun 4, 2012