Overview
First Time in Human Study Using GSK2330672
Status:
Completed
Completed
Trial end date:
2011-09-09
2011-09-09
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to look at the safety and tolerability of increasing single doses of GSK2330672 in healthy volunteers.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
GlaxoSmithKline
Criteria
Inclusion Criteria:- 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 Criteria:
- 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.