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.

Phase 1

Completed

• Conditions: Healthy; Diabetes
• Interventions: Drug: Semaglutide; Drug: SNAC; Drug: Levothyroxine; Drug: Placebo

• Registration Number: NCT02920385
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2016-09-29
• Study First Posted: 2016-09-30
• Study Start: 2016-10-10
• Primary Completion: 2017-04-26
• Study Completion: 2017-06-16
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-13
• Last Update Posted: 2017-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Levothyroxine/SNAC/Placebo/Semaglutide	SNAC	-
Levothyroxine/SNAC/Placebo/Semaglutide	Placebo	-
Levothyroxine/SNAC/Placebo/Semaglutide	Semaglutide	-
Levothyroxine/SNAC/Placebo/Semaglutide	Levothyroxine	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Berlin, Germany