A Second Study to Determine the Effect of GSK256073A on HVTs

NCT00551694 | Completed Phase 1

• 1 other identifier: HMA110541
• Study Type: interventional
• Target: 4
• 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 that have been administrated GSK256073 in the HMA107787 study

Conditions

Healthy Subjects; Dyslipidaemias

Keywords

GSK256073A

Outcome Measures

Primary Outcomes (3)

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

  throughout the study.

• AUC and Cmax

  throughout the study

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

  throughout the study

Secondary Outcomes (2)

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

  throughout the study

• 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.

  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 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Minneapolis, Minnesota, 55404, United States

Location

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2007
• First Posted: October 31, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: June 4, 2012

Record last verified: 2011-02

Locations

US (1)