Safety, Tolerability, and Profile of Action of Drug in the Body of NN9535 in Healthy Male Japanese and Caucasian Subjects

Sponsor
Novo Nordisk A/S
Study ID
NCT00851773
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes
  • Healthy

Eligibility Criteria

Sex
MALE
Age
20 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • semaglutide — DRUG
    0.1 mg once weekly, s.c. injection
  • semaglutide — DRUG
    0.2 mg once weekly, s.c. injection
  • semaglutide — DRUG
    0.4 mg once weekly, s.c. injection
  • semaglutide — DRUG
    0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. injection
  • semaglutide — DRUG
    0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, 1.2 mg once weekly for 6 weeks, s.c. injection
  • placebo — DRUG
    0.1 mg once weekly, s.c. injection
  • placebo — DRUG
    0.2 mg once weekly, s.c. injection
  • placebo — DRUG
    0.4 mg once weekly, s.c. injection
  • placebo — DRUG
    0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. injection
  • placebo — DRUG
    0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, followed by 1.2 mg once weekly injections for 6 weeks, s.c. injection

Study Details

This trial is conducted in Europe. The aim of this clinical trial is to assess and compare the safety and tolerability, as assessed by adverse events after multiple subcutaneous doses of NN9535 in healthy male Japanese and Caucasian subjects.

Key Dates

Start date
Feb 28, 2009
Status verified
Feb 2015
Primary completion
Oct 31, 2009
Completion
Oct 31, 2009

Study Design

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

Arms

  • Experimental: A
  • Experimental: B
  • Experimental: C
  • Experimental: D
  • Experimental: E
  • Placebo Comparator: F1
  • Placebo Comparator: F2
  • Placebo Comparator: F3
  • Placebo Comparator: F4
  • Placebo Comparator: F5

Primary Outcome Measure

Adverse events [ Time Frame: at all scheduled visits (2 - 14) following screening ]

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