- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00488449
Study Of Pharmacokinetics and Pharmacodynamics Effects Of GSK256073A On Healthy Volunteers
May 31, 2012 updated by: GlaxoSmithKline
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21225
- GSK Investigational Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AEs, 12-Lead ECG, vital signs, nursing/physician observation, safety lab tests, flushing
Time Frame: throughout the study (Parts A &B)
|
throughout the study (Parts A &B)
|
AUC and Cmax
Time Frame: throughout the study (Part A & B)
|
throughout the study (Part A & B)
|
Measures of accumulation ratios
Time Frame: throughout the study (Ro, Rp, and Rs)[Part B]
|
throughout the study (Ro, Rp, and Rs)[Part B]
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tmax, t½, Ae, and CLr (Parts A & B) Cmax, ss, Ct, t½, Ae, CLr, and accumulation ratios (Part B)
Time Frame: throughout the study
|
throughout the study
|
PD response: NEFA and TG (6 and 24 hours post- dose)
Time Frame: (6 and 24 hours post- dose)
|
(6 and 24 hours post- dose)
|
LDL, HDL, ApoA1, ApoA2, Apo B and Lp(a)
Time Frame: on Days 1, 14, and 15.
|
on Days 1, 14, and 15.
|
Levels of GSK256073 to derive pharmacokinetic parameters following repeat dose administration.
|
|
Lipid levels
Time Frame: on Days 1, 14, and 15
|
on Days 1, 14, and 15
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
June 18, 2007
First Submitted That Met QC Criteria
June 19, 2007
First Posted (Estimate)
June 20, 2007
Study Record Updates
Last Update Posted (Estimate)
June 4, 2012
Last Update Submitted That Met QC Criteria
May 31, 2012
Last Verified
February 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HMA110015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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