Investigating the Pharmacokinetics of Subcutaneous Injections With 1 mg/mL, 3 mg/mL, and 10 mg/mL Semaglutide Strengths and the Absolute Bioavailability of Semaglutide

Sponsor
Novo Nordisk A/S
Study ID
NCT02231684
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes
  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • semaglutide — DRUG
    Semaglutide administered subcutaneously (s.c. under the skin) in two out of three different strengths (1mg/mL, 3mg/mL and 10 mg/mL).
  • semaglutide — DRUG
    Semaglutide administered subcutaneously (s.c. under the skin) in two out of three different strengths (1mg/mL, 3mg/mL and 10 mg/mL) or intravenously (i.v.) (1mg/mL).

Study Details

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of subcutaneous injections of three different strengths of semaglutide and the absolute bioavailability of semaglutide.

Key Dates

Start date
Sep 30, 2014
Status verified
Jan 2015
Primary completion
Jan 31, 2015
Completion
Jan 31, 2015

Study Design

Enrollment
42 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (3 mg/ml)
  • Experimental: s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)
  • Experimental: s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (10 mg/ml)
  • Experimental: s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (3 mg/ml)
  • Experimental: s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (10 mg/ml)
  • Experimental: s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)
  • Experimental: i.v. 0.25 mg (1 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)
  • Experimental: s.c. 0.5 mg (1 mg/ml) followed by i.v. 0.25 mg (1 mg/ml)

Primary Outcome Measure

Area under the semaglutide plasma concentration curve [ Time Frame: From day 0-day 35/840 hours ]

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