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.

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Diabetes
• Intervention / Treatment: Drug: Semaglutide; Drug: SNAC; Drug: Levothyroxine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14050
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female aged 18-50 years (both inclusive) at the time of signing informed consent
• Body mass index (BMI) 20.0 to 29.9 kg/m^2 (both inclusive)
• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

• Smoker (defined as a subject who is smoking at least 1 cigarette or the equivalent per day)
• Unable or unwilling to refrain from smoking and use of nicotine substitute products within 48 hours prior to and during the inpatient periods
• Any blood draw in excess of 25 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within the 90 days preceding screening
• History (as declared by the subject) of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
• History (as declared by the subject) or presence of clinical or non-clinical thyroid disease, including thyroid palpation abnormalities, levels of T3 or T4 (total and free) or TSH outside reference limits, or presence of thyroid antibodies (Thyroid Stimulating Hormone Receptor Antibody, Thyroperoxidase Antibody or Thyroid Antithyroglobulin Antibodies)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Levothyroxine/SNAC/Placebo/Semaglutide	Drug: Semaglutide; Oral administration once daily alone or together with levothyroxine or Placebo; Drug: SNAC; Oral administration once daily alone or together with levothyroxine or semaglutide; Drug: Levothyroxine; Oral administration alone or together with SNAC or oral semaglutide; Drug: Placebo; Oral administration once daily together with semaglutide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Baseline-corrected area under the total T4 serum concentration-time curve from 0 to 48 hours after a single dose of levothyroxine	On day 1 (levothyroxine administered alone), on day 38 (levothyroxine co-administered with SNAC) and on day 89 (levothyroxine co-administered with oral semaglutide)
Area under the semaglutide plasma concentration-time curve during a dosing interval (0-24 hours) at steady state	On day 88 (oral semaglutide administered alone) and on day 139 (oral semaglutide co-administered with placebo tablets)

Secondary Outcome Measures

Outcome Measure	Time Frame
Baseline-corrected maximum observed total T4 serum concentration from 0 to 48 hours after a single dose of levothyroxine	On day 1 (levothyroxine administered alone), on day 38 (levothyroxine co-administered with SNAC) and on day 89 (levothyroxine co-administered with oral semaglutide)
Maximum observed semaglutide plasma concentration during a dosing interval from (0-24 hours) at steady state	On day 88 (oral semaglutide administered alone) and on day 139 (oral semaglutide co-administered with placebo tablets)
Area under the SNAC plasma concentration-time curve during a dosing interval (0-24 hours) at steady state	On day 88 (oral semaglutide administered alone) and on day 139 (oral semaglutide co-administered with placebo tablets)
Maximum observed SNAC plasma concentration during a dosing interval (0-24 hours) at steady state	On day 88 (oral semaglutide administered alone) and on day 139 (oral semaglutide co-administered with placebo tablets)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2016
• Primary Completion (Actual): April 26, 2017
• Study Completion (Actual): June 16, 2017

Study Registration Dates

• First Submitted: September 29, 2016
• First Submitted That Met QC Criteria: September 29, 2016
• First Posted (Estimate): September 30, 2016

Study Record Updates

• Last Update Posted (Actual): December 14, 2017
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: NN9924-4279; 2015-005558-36 (EudraCT Number); U1111-1177-2807 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: According to Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No