Investigation on Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of a Long-acting GLP-1 Analogue (Semaglutide) in an Oral Formulation in Healthy Male Subjects
|ClinicalTrials.gov Identifier: NCT01866748|
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : April 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Diabetes Mellitus, Type 2 Healthy||Drug: semaglutide Drug: placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Investigation on Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of a Long-acting GLP-1 Analogue (Semaglutide) in an Oral Formulation in Healthy Male Subjects|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
|Experimental: Part A (single dose)||
A maximum of six single-dose cohorts of oral semaglutide administered according to an ascending dose design. Starting dose 2 mg, max. dose 60 mg. Progression to next dose will be based on safety evaluation. Sequential cohorts.
In each cohort of 10, eight subjects will randomised to active treatment and two to placebo.
|Experimental: Part B (multiple dose)||
Oral semaglutide administered as five multiple dose cohorts, where one of the cohorts will test a different dosing condition compared to the others. End doses from 10 mg/day to 60 mg/day. Progression to next dose will be based on safety evaluation. Semi-parallel cohorts.
In each cohort of 24, 16 subjects will be randomised to active treatment, four to placebo and four to a enhancer-containing placebo (placebo C).
- Part A: Number of treatment emergent adverse events (TEAEs) [ Time Frame: Day -1 to Day 24 ]
- Part B: Number of treatment emergent adverse events (TEAEs) [ Time Frame: Recorded from the time of first dosing (Visit 3, Day -1 to day +2) and until completion of the post treatment follow-up visit (Visit 18, Day 90-104) ]
- Part A: AUC0-24h,semaglutide: the area under the semaglutide plasma concentration curve [ Time Frame: From time 0 to 24 hours after a single dose (Day 0) ]
- Part B: AUCτ,semaglutide: area under the semaglutide plasma concentration curve [ Time Frame: Over the dosing interval (0-24 hours) after the last 3 daily doses (Days 67-69) ]
- Part B: Change in fasting plasma glucose (FPG) from baseline [ Time Frame: Day 0 (pre-dose), day 70 ]
- Part B: Change in body weight from baseline [ Time Frame: Day -1, day 70 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866748
|Berlin, Germany, 14050|
|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|