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

Sponsor
Novo Nordisk A/S
Study ID
NCT02161588
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
20 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • semaglutide — DRUG
    Once-daily oral administration as tablets. The dose level of oral semaglutide used in the 'Dose escalation period', 'Treatment period 1', 'Treatment period 2' and 'Treatment period 3' will be 5, 10, 20 and 40 mg per day, respectively.
  • placebo — DRUG
    Once-daily oral administration as tablets.

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), safety and tolerability of oral semaglutide in healthy male Japanese and Caucasian subjects.

Key Dates

Start date
Jun 30, 2014
Status verified
Dec 2014
Primary completion
Nov 30, 2014
Completion
Nov 30, 2014

Study Design

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

Arms

  • Experimental: Semaglutide
  • Placebo Comparator: Placebo

Primary Outcome Measure

Area under the semaglutide plasma concentration-time curve [ Time Frame: During a dosing interval (0-24 hours) at steady state ]

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