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.

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02920385
• Other study ID #: NN9924-4279
• Secondary ID: 2015-005558-36U1
• Status: Completed
• Phase: Phase 1
• First received: September 29, 2016
• Last updated: December 13, 2017
• Start date: October 10, 2016
• Est. completion date: June 16, 2017

Study information

• Verified date: December 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 16, 2017
• Est. primary completion date: April 26, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

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

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)