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Clinical Trial Details

Trial ID: L5481
Source ID: NCT01545570
Associated Drug: Gsk2376497
Title: A Study to Determine the Safety, Tolerability, and Effects of GSK2374697 in Healthy Volunteers
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: GSK2376497|DRUG: 0.9% sodium chloride
Outcome Measures: Primary: Number of subjects with adverse events after ascending single or titrated mulitple subcutaneous doses of GSK2374697, Adverse events, laboratory parameters, ECGs, and vital signs, up to 70 days post dose|pharmacokinetic parameters of GSK2374697, after ascending single or titrated multiple subcutaneous doses, in healthy subjects, Pharmacokinetics parameters: AUCs, Cmax, tmax, elimination half-life (t½), lag time (tlag), apparent clearance (CL/F) and apparent volume of distribution (V/F), area under the plasma drug concentration versus time curve on Days 1 through end of study (up to 70 Days), pre-dose, then 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, and 66 hours after dose (this schedule is q6h through Day 3, up to just prior to Day 4). In addition, sampling continues out through Day 70, on specific days, q12h. | Secondary: pharmacodynamic effects of GSK2374697 in healthy subjects after meal challenge, Fasting, 2h, and Cmax parameters on Day -1 and approximately Day 6 (or Day 16), On 2 days|dose proportionality of GSK2374697, Pharmacokinetics parameters based on single and/or titrated multiple subcutaneous doses of GSK2374697, up to 70 days post dose
Sponsor/Collaborators: Sponsor: GlaxoSmithKline
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 82
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2011-11-07
Completion Date: 2012-12-23
Results First Posted:
Last Update Posted: 2017-07-25
Locations: GSK Investigational Site, Minneapolis, Minnesota, 55404, United States
URL: https://clinicaltrials.gov/show/NCT01545570