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.

NCT02920385 | Completed Phase 1

• 3 other identifiers: NN9924-42792015-005558-36U1111-1177-2807
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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)

Study Arms (1)

Levothyroxine/SNAC/Placebo/Semaglutide

EXPERIMENTAL

Drug: Semaglutide; Drug: SNAC; Drug: Levothyroxine; Drug: Placebo

Interventions

Semaglutide DRUG

Oral administration once daily alone or together with levothyroxine or Placebo

Levothyroxine/SNAC/Placebo/Semaglutide

SNAC DRUG

Oral administration once daily alone or together with levothyroxine or semaglutide

Levothyroxine/SNAC/Placebo/Semaglutide

Levothyroxine DRUG

Oral administration alone or together with SNAC or oral semaglutide

Levothyroxine/SNAC/Placebo/Semaglutide

Placebo DRUG

Oral administration once daily together with semaglutide

Levothyroxine/SNAC/Placebo/Semaglutide

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Berlin, 14050, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

semaglutide; Thyroxine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: September 30, 2016
• Study Start: October 10, 2016
• Primary Completion: April 26, 2017
• Study Completion: June 16, 2017
• Last Updated: December 14, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)