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

Sponsor
Novo Nordisk A/S
Study ID
NCT01866748
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • semaglutide — DRUG
    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.
  • semaglutide — DRUG
    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.
  • placebo — DRUG
    In each cohort of 10, eight subjects will randomised to active treatment and two to placebo.
  • placebo — DRUG
    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).

Study Details

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability and pharmacokinetics (the effect of the investigated drug on the body) of single and multiple doses of a long-acting GLP-1 analogue (semaglutide) in an oral formulation in healthy male subjects.

Key Dates

Start date
May 31, 2013
Status verified
Apr 2014
Primary completion
Apr 30, 2014
Completion
Apr 30, 2014

Study Design

Enrollment
170 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A (single dose)
  • Experimental: Part B (multiple dose)

Primary Outcome Measure

Part A: Number of treatment emergent adverse events (TEAEs) [ Time Frame: Day -1 to Day 24 ]

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