Status:
COMPLETED
First Time in Human Study Using GSK2330672
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to look at the safety and tolerability of increasing single doses of GSK2330672 in healthy volunteers.
Detailed Description
This is a single blind, randomized, placebo-controlled, dose escalating, crossover, first time in human study to examine safety, tolerability, pharmacokinetic and pharmacodynamic parameters of GSK2336...
Eligibility Criteria
Inclusion
- healthy volunteer
- 18-60 yrs of age
- for subjects age 50 and above: negative fecal occult blood test within 3 months prior to expected start of dosing, and normal results from sigmoidoscopy or colonoscopy within 5 yrs prior to dosing.
- if female, must be of non-childbearing potential
Exclusion
- pregnant or breastfeeding females
- positive HIV
- positive Hep B, or Hep C within 3 months of screening
- positive drugs of abuse screening
- triglycerides \> 250 mg/dL
- current or chronic history of liver disease
- any gastrointestinal or gastrointestinal related conditions that could affect fat or bile acid reabsorption
- pancreatitis
- colon cancer or 1st degree relative who has had colon cancer
- abnormal lung function tests
- inability to perform lung function tests
- unwilling to abstain from smoking, alcohol, caffeine, illicit drugs as directed by the site staff
- exposure to more than 4 new chemical entities in the 12 months prior to the first dosing day.
- where participation in the study would results in donation of more than approximately 550mL of blood in a 56-day period.
Key Trial Info
Start Date :
June 15 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2011
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01416324
Start Date
June 15 2011
End Date
September 9 2011
Last Update
June 20 2017
Active Locations (1)
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1
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404