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Sponsored by: |
GlaxoSmithKline |
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00607906 |
This study will use single escalating doses of SB756050 to assess safety, pharmacokinetics, and pharmacodynamics in healthy volunteers and in subjects with Type 2 Diabetes Mellitus.
Condition | Intervention | Phase |
Type 2 Diabetes Mellitus |
Drug: SB756050 |
Phase I |
MedlinePlus related topics: | Diabetes |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Parallel Assignment, Safety Study |
Official Title: | A Single-Blinded, Randomized, Placebo-Controlled, Staggered-Parallel, Escalating Single Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered SB756050 in Healthy Volunteers and in Subjects With Type 2 Diabetes Mellitus |
Estimated Enrollment: | 48 |
Study Start Date: | November 2007 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Healthy Subjects
Diabetic Subjects
T2DM diagnosed at least 3 months prior to Screening with
Exclusion Criteria:
Has any of the following laboratory abnormalities:
Unwilling to abstain from
Healthy Subjects
Has any of the following laboratory abnormalities:
Has a history of any of the following conditions:
Is taking prohibited medications:
Unwilling to abstain from
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | AXO110461 |
First Received: | January 23, 2008 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00607906 |
Health Authority: | United States: Food and Drug Administration |
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