A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Levothyroxine and the Influence of Co-administered Tablets on the Pharmacokinetics of Semaglutide Administered Orally in Healthy Subjects.

Sponsor
Novo Nordisk A/S
Study ID
NCT02920385
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes
  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Semaglutide — DRUG
    Oral administration once daily alone or together with levothyroxine or Placebo
  • SNAC — DRUG
    Oral administration once daily alone or together with levothyroxine or semaglutide
  • Levothyroxine — DRUG
    Oral administration alone or together with SNAC or oral semaglutide
  • Placebo — DRUG
    Oral administration once daily together with semaglutide

Study Details

This trial is conducted in Europe. The aim of this trial is to investigate the influence of oral semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of levothyroxine and the influence of co-administered tablets on the pharmacokinetics of semaglutide administered orally in healthy subjects.

Key Dates

Start date
Oct 10, 2016
Status verified
Dec 2017
Primary completion
Apr 26, 2017
Completion
Jun 16, 2017

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Levothyroxine/SNAC/Placebo/Semaglutide

Primary Outcome Measure

Baseline-corrected area under the total T4 serum concentration-time curve from 0 to 48 hours after a single dose of levothyroxine [ Time Frame: On day 1 (levothyroxine administered alone), on day 38 (levothyroxine co-administered with SNAC) and on day 89 (levothyroxine co-administered with oral semaglutide) ]

Related Studies