Investigating the Influence of Semaglutide on the Pharmacokinetics of Single Doses of Atorvastatin and Digoxin in Healthy Subjects

Sponsor
Novo Nordisk A/S
Study ID
NCT02243098
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes
  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • semaglutide — DRUG
    Administered as a subcutaneous injection (s.c., under the skin). Initiated with weekly semaglutide dosing of 0.25 mg in the first 4 weeks, 0.5 mg the next 4 weeks, and 1.0 mg in the third 4 week period.
  • digoxin — DRUG
    Oral administration. Digoxin will be given as 2 single doses of 0.5 mg.
  • atorvastatin — DRUG
    Oral administration. Atorvastatin will be given as 2 single doses of 40 mg.

Study Details

The trial is conducted in Europe. The aim of the trial is to investigate the influence of semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of single doses of atorvastatin and digoxin in healthy subjects.

Key Dates

Start date
Sep 16, 2014
Status verified
Mar 2017
Primary completion
Apr 7, 2015
Completion
Apr 7, 2015

Study Design

Enrollment
31 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Semaglutide

Primary Outcome Measure

Area under the atorvastatin plasma concentration-time curve [ Time Frame: From time 0 to 72 hours after a single dose ]

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