Last updated: 11/04/2018 08:09:42
Study Of Pharmacokinetics and Pharmacodynamics Effects Of GSK256073A On Healthy Volunteers
GSK study ID
HMA110015
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: The purpose of this study is to compare the effects of single and repeat doses of GSK256073 with placebo in HVT subjects.
Primary purpose:
Diagnostic
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
AEs, 12-Lead ECG, vital signs, nursing/physician observation, safety lab tests, flushing
Timeframe: throughout the study (Parts A &B)
AUC and Cmax
Timeframe: throughout the study (Part A & B)
Measures of accumulation ratios
Timeframe: throughout the study (Ro, Rp, and Rs)[Part B]
Secondary outcomes:
Tmax, t½, Ae, and CLr (Parts A & B) Cmax, ss, Ct, t½, Ae, CLr, and accumulation ratios (Part B)
Timeframe: throughout the study
PD response: NEFA and TG (6 and 24 hours post- dose)
Timeframe: (6 and 24 hours post- dose)
LDL, HDL, ApoA1, ApoA2, Apo B and Lp(a)
Timeframe: on Days 1, 14, and 15.
Lipid levels
Timeframe: on Days 1, 14, and 15
Interventions:
Drug: GSK256073A tablets
Enrollment:
56
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy Subjects, Dyslipidaemias
Product
GSK256073
Collaborators
Not applicable
Study date(s)
June 2007 to November 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Healthy Adult males or females between 18 and 55 years of age, inclusive.
- Female subjects must be of non-childbearing potential
- Systolic blood pressure < 100 mmHg or 150 mmHg and/or diastolic blood pressure = 100 mmHg at screening.
- History of significant cardiac arrhythmias
Inclusion and exclusion criteria
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
Trial location(s)
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21225
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-30-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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