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.

NCT ID: NCT02920385

Last Updated: 2017-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-10
• Study Completion Date: 2017-06-16

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.

Conditions

Diabetes; Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Levothyroxine/SNAC/Placebo/Semaglutide

Group Type: EXPERIMENTAL

Semaglutide

Intervention Type: DRUG

Oral administration once daily alone or together with levothyroxine or Placebo

SNAC

Intervention Type: DRUG

Oral administration once daily alone or together with levothyroxine or semaglutide

Levothyroxine

Intervention Type: DRUG

Oral administration alone or together with SNAC or oral semaglutide

Placebo

Intervention Type: DRUG

Oral administration once daily together with semaglutide

Interventions

Semaglutide

Oral administration once daily alone or together with levothyroxine or Placebo

Intervention Type: DRUG

SNAC

Oral administration once daily alone or together with levothyroxine or semaglutide

Intervention Type: DRUG

Levothyroxine

Oral administration alone or together with SNAC or oral semaglutide

Intervention Type: DRUG

Placebo

Oral administration once daily together with semaglutide

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Novo Nordisk Investigational Site

Berlin, , Germany

Countries

Germany

Other Identifiers

2015-005558-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1177-2807

Identifier Type: OTHER

Identifier Source: secondary_id

NN9924-4279

Identifier Type: -

Identifier Source: org_study_id