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Completed

NCT Number: NCT02920385

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

semaglutide

Drug

Oral administration once daily alone or together with levothyroxine or Placebo

SNAC

Drug

Oral administration once daily alone or together with levothyroxine or semaglutide

Levothyroxine

Drug

Oral administration alone or together with SNAC or oral semaglutide

Placebo

Drug

Oral administration once daily together with semaglutide

Primary outcomes

  1. Baseline-corrected area under the total T4 serum concentration-time curve from 0 to 48 hours after a single dose of levothyroxine

    Time frame: On day 1 (levothyroxine administered alone), on day 38 (levothyroxine co-administered with SNAC) and on day 89 (levothyroxine co-administered with oral semaglutide)

  2. Area under the semaglutide plasma concentration-time curve during a dosing interval (0-24 hours) at steady state

    Time frame: On day 88 (oral semaglutide administered alone) and on day 139 (oral semaglutide co-administered with placebo tablets)

Secondary outcomes

  1. Baseline-corrected maximum observed total T4 serum concentration from 0 to 48 hours after a single dose of levothyroxine

    Time frame: On day 1 (levothyroxine administered alone), on day 38 (levothyroxine co-administered with SNAC) and on day 89 (levothyroxine co-administered with oral semaglutide)

  2. Maximum observed semaglutide plasma concentration during a dosing interval from (0-24 hours) at steady state

    Time frame: On day 88 (oral semaglutide administered alone) and on day 139 (oral semaglutide co-administered with placebo tablets)

  3. Area under the SNAC plasma concentration-time curve during a dosing interval (0-24 hours) at steady state

    Time frame: On day 88 (oral semaglutide administered alone) and on day 139 (oral semaglutide co-administered with placebo tablets)

  4. Maximum observed SNAC plasma concentration during a dosing interval (0-24 hours) at steady state

    Time frame: On day 88 (oral semaglutide administered alone) and on day 139 (oral semaglutide co-administered with placebo tablets)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 30, 2016
Registry last updated
Dec 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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