Effect of Food on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects

Sponsor
Novo Nordisk A/S
Study ID
NCT02172313
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes
  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This trial is conducted in Europe. The aim of the trial is to investigate the effect of food on the pharmacokinetics (the exposure of the trial drug in the body) of oral semaglutide, in a SNAC (sodium N-\[8-(2-hydroxybenzoyl) amino\] caprylate) tablet formulation with three different dosing conditions in healthy subjects.

Key Dates

Start date
Jun 30, 2014
Status verified
Oct 2014
Primary completion
Oct 31, 2014
Completion
Oct 31, 2014

Study Design

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

Arms

  • Experimental: Fed conditions
    Fasting for 10 hours overnight followed by a high-fat, high-calorie meal, after the meal dosing of the tablet with 240 mL of water and a post-dose fasting period of 4 hours
  • Experimental: Fasting conditions
    Fasting for 10 hours overnight followed by dosing of the tablet with 240 mL of water and a post-dose fasting period of 4 hours
  • Experimental: Reference dosing condition
    Fasting for 6 hours overnight followed by dosing of the tablet with 120 mL of water and a post-dose fasting period of 30 min

Primary Outcome Measure

Area under the semaglutide plasma concentration time curve [ Time Frame: From time 0 to 24 hours after the 10th daily dose ]

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