A Study in Healthy Volunteers of Single Doses of Orally Administered Investigational Product to Investigate Safety, Tolerability, and Pharmacokinecs.

NCT00783549 | Completed Phase 1

• 1 other identifier: 111596
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This study is the first study in humans to assess the safety and tolerability of various doses of GSK1292263 alone, and taken with sitigliptan.

Conditions

Dyslipidaemias

Keywords

tolerability; pharmacodynamics; pharmacokinetics; safety

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability parameters including adverse events, clinical laboratory, electrocardiogram, and vital signs assessments.

  Up to 4 days

• Pharmacokinetic parameters, maximum observed plasma drug concentration, time to maximum observe.

  Up to 4 days

Secondary Outcomes (3)

• Pharmacodynamic endpoints

  Up to four days.

• • Pharmacokinetic parameters following a dose, with and without food, and bioavailability

  Up to four days.

• Relationships betwen drug exposures and pharmacodynamic parameters, safety, and tolerability, as appropriate.

  Up to four days.

Study Arms (5)

Cohort 1

EXPERIMENTAL

6 active 2 placebo

Drug: an undetermined dose of GSK1292263

Cohort 2

EXPERIMENTAL

9 active 3 placebo

Drug: ascending dose of GSK1292263

Cohort 3

EXPERIMENTAL

Optional cohort

Drug: ascending dose of GSK1292263

Cohort 4

EXPERIMENTAL

12 active

Drug: ascending dose of GSK1292263

Cohort 5

EXPERIMENTAL

12 active

Drug: ascending dose of GSK1292263

Interventions

an undetermined dose of GSK1292263 DRUG

GSK investigational product or placebo

Cohort 1

ascending dose of GSK1292263 DRUG

Ascending dose based on target exposures or placebo

Cohort 2

Eligibility Criteria

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

You may qualify if:

• Healthy Male or female between 18 and 55 years of age
• A female subject is eligible to participate if she is of non-childbearing potential
• Male subjects must agree to use one of the contraception methods listed in the protocol
• BMI within the range 20 - 29.9 kg/m2
• Capable of giving written informed consent, which includes compliance with protocol
• QTcB or QTcF \< 450msec.

You may not qualify if:

• The subject has a positive pre-study drug/alcohol screen
• Positive urinary cotinine levels or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
• History of regular alcohol consumption within 6 months of the study
• History of sensitivity to heparin or heparin-induced thrombocytopenia
• Unable or unwilling to abstain from caffeine-or xanthine-containing products for 24 hours prior to dosing until the final post-dose assessment at each treatment level.
• Use of illicit drugs.
• Use of alcohol for 24 hours prior to dosing until final post-dose assessment at each treatment level.
• Consumption of red wine, oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication until collection of the final pharmacokinetic and pharmacodynamic blood samples
• 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
• Pregnant females as determined by positive urine hCG test at screening or prior to dosing
• Lactating females
• Has a fasting triglyceride level \>400mg/dL (4.45mmol/L)
• Has anemia defined by hemoglobin concentration \<11.0g/dL for males or \<10.0g/dL for females.
• CPK values higher than 2.5 times the upper limit of normal at screening.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Minneapolis, Minnesota, 55404, United States

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study 111596 can be found on the GSK Clinical Study Register.

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2008
• First Posted: October 31, 2008
• Study Start: September 4, 2008
• Primary Completion: March 31, 2009
• Study Completion: March 31, 2009
• Last Updated: July 7, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)