A Trial to Assess the Pharmacokinetics, Pharmacodynamics, and the Safety and Tolerability of Semaglutide in Healthy Male Japanese and Caucasian Subjects

Sponsor
Novo Nordisk A/S
Study ID
NCT02146079
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
20 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • semaglutide — DRUG
    Subjects will be randomised to receive either semaglutide 0.5 mg, semaglutide 0.5 mg placebo, semaglutide 1.0 mg or semaglutide 1.0 mg placebo within each group. Treatment with active drug or placebo blinded within each dose level. After randomisation, the subjects will follow a fixed dose escalation. The maintenance dose of 0.5 mg will be reached after 4 weeks of 0.25 mg. The maintenance dose of 1.0 mg will be reached after 8 weeks (4 weeks) of 0.25 mg and 4 weeks of 0.5 mg). Once-weekly subcutaneous (s.c., under the skin) administration. Trial duration per subject is 18 to 21 weeks depending on the individual subject's schedule
  • placebo — DRUG
    Subjects will be randomised to receive either semaglutide 0.5 mg, semaglutide 0.5 mg placebo, semaglutide 1.0 mg or semaglutide 1.0 mg placebo within each group. Treatment with active drug or placebo blinded within each dose level. After randomisation, the subjects will follow a fixed dose escalation. The maintenance dose of 0.5 mg will be reached after 4 weeks of 0.25 mg. The maintenance dose of 1.0 mg will be reached after 8 weeks (4 weeks) of 0.25 mg and 4 weeks of 0.5 mg). Once-weekly subcutaneous (s.c., under the skin) administration. Trial duration per subject is 18 to 21 weeks depending on the individual subject's schedule.

Study Details

This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), pharmacodynamics (the effect of the investigated drug on the body), and the safety and tolerability of semaglutide in healthy male Japanese and Caucasian subjects.

Key Dates

Start date
May 21, 2014
Status verified
Apr 2018
Primary completion
Oct 20, 2014
Completion
Oct 20, 2014

Study Design

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

Arms

  • Experimental: Semaglutide 0.5 mg
    Dose-escalation trial
  • Placebo Comparator: Semaglutide placebo 0.5 mg
  • Experimental: Semaglutide 1.0 mg
    Dose-escalation trial
  • Placebo Comparator: Semaglutide placebo 1.0 mg

Primary Outcome Measure

Area under the plasma semaglutide concentration-time curve [ Time Frame: During a dosing interval (0-168 hours) at steady state ]

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