Repeat Dose Food Effect Study of GSK256073F in Healthy Adult Subjects

NCT00808093 | Completed Phase 1

• 1 other identifier: 106777
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effects of fasting and fed conditions with repeat doses of GSK256073F in HVT subjects.

Conditions

Dyslipidaemias

Keywords

Food Effect; GSK256073F; TRIS Salt

Outcome Measures

Primary Outcomes (2)

• 1. AUC0-inf, Cmax, and Ctrough (Ct) under fasting conditions

  throughout study

• 2. AUC0-inf, Cmax, and Ctrough (Ct) under fed conditions

  throughout the study

Secondary Outcomes (3)

• 1. Safety and tolerability will be assessed by vital signs, ECGs, clinical laboratory data, spontaneous AE reporting, nursing/physician observation and assessment of flushing via a visual analog scale

  throughout the study

• 2. Tmax, t½ (if data permits), Ae (amount excreted in the urine), CLr (renal clearance), Cmax, ss, and Cτ following repeat dose

  throughout the study

• 3. Pharmacodynamic endpoints may include TC, NEFA, HDL, LDL, TG, ApoA1, ApoA2, ApoB, Lp(a), CETP, adiponectin, liposcience (particle sizing) or other markers of dyslipidemia on Days 1, 14, 21, and 28, as data permit.

  throughout the study

Study Arms (1)

fixed sequence

OTHER

fixed sequence (14 days fasted followed by 14 days either high fat or standard meal

Drug: GSK256073

Interventions

GSK256073 DRUG

GSK256073 100 mg study drug

fixed sequence

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 medical history, physical examination, laboratory tests and 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 and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
• Male or female of non-childbearing potential between 18 and 55 years of age.
• A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 MlU/ml and estradiol \< 40 pg/ml (\<140 pmol/L) is confirmatory\].
• Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 3 days post-last dose.
• Body weight \> 50 kg (110 pounds) and BMI within the range 19 - 31 kg/m2 (inclusive).
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• QTcB or QTcF \< 450 msec

You may not qualify if:

• The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines
• A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
• A positive test for HIV antibody.
• History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of \>14 drinks/week for men or \>7 drinks/week for women. One drink is equivalent to (12 g alcohol) = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits.
• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
• Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. An exception is acetaminophen which is allowed at doses of ≤ 2g/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 investigator or GSK Medical Monitor, contraindicates their participation.
• Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
• Unwillingness or inability to follow the procedures outlined in the protocol.
• 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.
• Screening test positive for H. Pylori using the non-radioactive breath test.
• A serum uric acid concentration ≥ 8mg/dL

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

8-chloro-3-pentyl-1H-purine-2,6(3H,7H)-dione

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 11, 2008
• First Posted: December 15, 2008
• Study Start: May 12, 2008
• Primary Completion: August 27, 2008
• Study Completion: August 27, 2008
• Last Updated: June 5, 2017

Record last verified: 2017-06

Locations

US (1)