Clinical trial NCT04097600: A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets
Official title: A Comparative Bioavailability Trial of Steady State Semaglutide Exposure With the Current Formulation (Semaglutide) and a New Formulation (Semaglutide D) of Oral Semaglutide in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Type 2 Diabetes
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-09-20
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this study two different tablets for oral use of a known investigational medicinal product, called semaglutide, will be tested. One is the current formulation and the other one is a new formulation of semaglutide. Both will be administered as a tablet and are for the treatment of diabetes. Currently, semaglutide is only prescribed as injections for the treatment of diabetes in some countries. The aim of this study is to find out if the dosage strength of the current formulation of semaglutide can be reduced in the new tablet formulation. For this purpose, it will be measured how much semaglutide is taken up in the body from the two (2) different tablet formulations each with three (3) different dosage strengths. The tablet version of the study medicine is a new medicine that cannot yet be prescribed. Participants will either get semaglutide in the current tablet formulation previously tested in many large studies, or get the tablet that contains semaglutide in a new formulation - which treatment is decided by chance. Participants will get one tablet per day over 4 weeks in each of the 3 treatment periods (i.e. treatment in a total of 12 weeks). The tablets should be taken in the morning together with half a glass of water (120 mL), after an overnight fast of at least 6 hours (no food or drinks). Furthermore, water is not allowed from 2 hours before dosing. After dosing participants must wait 30 minutes before they may eat or drink. At home, participants must take their breakfast 30-45 minutes after dosing.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent.
* Body mass index between 20.0 kg/m\^2 and 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:

* Glycated haemoglobin (HbA1c) equal to or above 6.5 % (48 mmol/mol) at screening.
* Use of tobacco and nicotine products, defined as any of the below:
* Smoking more than 5 cigarettes or the equivalent per day
* Not willing to refrain from smoking and use of nicotine substitute products during the in-house period(s)
* History (as declared by the subject) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
* Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
* Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by the subject).
* History (as declared by the subject) or presence of pancreatitis (acute or chronic).

Primary outcomes:
measure: AUC0-24h,sema,SS; area under the semaglutide plasma concentration-time curve during a dosing interval at steady state
timeFrame: From 0 to 24 hours after the last dosing of oral semaglutide low, medium and high dose on days 28, 56 and 84, respectively
Secondary outcomes:
measure: Cmax,sema,SS; maximum semaglutide plasma concentration at steady state
timeFrame: From 0 to 24 hours after the last dosing of oral semaglutide low, medium and high dose on days 28, 56 and 84, respectively
measure: tmax,sema,SS; time to maximum semaglutide plasma contraction at steady state
timeFrame: From 0 to 24 hours after the last dosing of oral semaglutide low, medium and high dose on days 28, 56 and 84, respectively
measure: t½,sema,SS; terminal half-life of semaglutide at steady state
timeFrame: Determined by concentrations measured between day 84 and follow-up at day 119 of semaglutide at steady state
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References: