Study Of Pharmacokinetics and Pharmacodynamics Effects Of GSK256073A On Healthy Volunteers

NCT00488449 | Completed Phase 1

• 1 other identifier: HMA110015
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects; Dyslipidaemias

Keywords

Dose Escalation; GSK256073A,

Outcome Measures

Primary Outcomes (3)

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

  throughout the study (Parts A &B)

• AUC and Cmax

  throughout the study (Part A & B)

• Measures of accumulation ratios

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

Secondary Outcomes (5)

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

  throughout the study

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

  (6 and 24 hours post- dose)

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

  on Days 1, 14, and 15.

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

• Lipid levels

  on Days 1, 14, and 15

Interventions

GSK256073A tablets DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Baltimore, Maryland, 21225, United States

Location

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2007
• First Posted: June 20, 2007
• Study Start: June 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: June 4, 2012

Record last verified: 2011-02

Locations

US (1)