Clinical trial 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.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-09-30
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Baseline-corrected area under the total T4 serum concentration-time curve from 0 to 48 hours after a single dose of levothyroxine
timeFrame: On day 1 (levothyroxine administered alone), on day 38 (levothyroxine co-administered with SNAC) and on day 89 (levothyroxine co-administered with oral semaglutide)
measure: Area under the semaglutide plasma concentration-time curve during a dosing interval (0-24 hours) at steady state
timeFrame: On day 88 (oral semaglutide administered alone) and on day 139 (oral semaglutide co-administered with placebo tablets)
Secondary outcomes:
measure: Baseline-corrected maximum observed total T4 serum concentration from 0 to 48 hours after a single dose of levothyroxine
timeFrame: On day 1 (levothyroxine administered alone), on day 38 (levothyroxine co-administered with SNAC) and on day 89 (levothyroxine co-administered with oral semaglutide)
measure: Maximum observed semaglutide plasma concentration during a dosing interval from (0-24 hours) at steady state
timeFrame: On day 88 (oral semaglutide administered alone) and on day 139 (oral semaglutide co-administered with placebo tablets)
measure: Area under the SNAC plasma concentration-time curve during a dosing interval (0-24 hours) at steady state
timeFrame: On day 88 (oral semaglutide administered alone) and on day 139 (oral semaglutide co-administered with placebo tablets)
measure: Maximum observed SNAC plasma concentration during a dosing interval (0-24 hours) at steady state
timeFrame: On day 88 (oral semaglutide administered alone) and on day 139 (oral semaglutide co-administered with placebo tablets)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
References: