Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects

Sponsor
Novo Nordisk A/S
Study ID
NCT01272973
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • semaglutide — DRUG
    Semaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level.
  • placebo — DRUG
    Placebo (oral) administered once daily for 10 weeks.
  • semaglutide — DRUG
    Administered s.c. (under the skin) once weekly for 10 weeks. Individually adjusted dose investigated up to maximum level.

Study Details

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of NN9924 in healthy male subjects

Key Dates

Start date
Jan 31, 2011
Status verified
Feb 2015
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011

Study Design

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

Arms

  • Experimental: Oral 1
  • Experimental: Oral 2
  • Experimental: Oral 3
  • Active Comparator: S.c.

Primary Outcome Measure

Frequency of adverse events (AEs) [ Time Frame: from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose ]

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