Research Study Comparing Different Tablets With the Study Medicine Semaglutide in Healthy Men

A Trial Comparing Exposure of Semaglutide When Dosing New Formulations of Oral Semaglutide to Healthy Male Subjects

This study looks at different tablets with a new study medicine called semaglutide. It is to treat diabetes. The aim of the study is to find out how much study medicine from 4 different tablets is taken up in the body. Participants will either get semaglutide in the tablet currently being studied in large studies, or 1 of the 3 new tablets that also contains 'semaglutide' - which treatment participants get is decided by chance. The tablet version of study medicine is a new medicine that cannot be prescribed. Semaglutide can be prescribed as injections for the treatment of diabetes in some countries. Participants will get 1 tablet per day for 10 days. The tablets should be taken in the morning by mouth together with half a glass of water. After dosing participants have to wait 30 minutes before participants may eat or drink. The study will last up to 70 days. Participants will have 17 clinic visits with the study doctor. Some of the visits are overnight stays. Participants will have blood tests at every visit.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Semaglutide 3 mg; Drug: Semaglutide 7 mg; Drug: Semaglutide B 3 mg; Drug: Semaglutide B 7 mg; Drug: Semaglutide C 3 mg; Drug: Semaglutide C 7 mg; Drug: Semaglutide D 3 mg; Drug: Semaglutide D 7 mg

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14050
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria: - Male, aged 18-64 years (both inclusive) at the time of signing informed consent. - Body mass index (BMI) between 20.0 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) greater than or equal to 6.5% (48 mmol/mol) at screening. - Use of tobacco and nicotine products, defined as any of the below: a) Smoking more than 5 cigarettes or the equivalent per day. b) Not willing to refrain from smoking and use of nicotine substitute products during the in-house period(s). - History* 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*. - History* or presence of pancreatitis (acute or chronic). *As declared by subject.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Oral semaglutide (reference); Participants will receive oral semaglutide (reference) for 10 days.	Drug: Semaglutide 3 mg; Semaglutide 3 mg will be administered once daily (OD) orally in the morning from day 1 to 5.; Drug: Semaglutide 7 mg; Semaglutide 7 mg will be administered OD orally in the morning from day 6 to 10.
EXPERIMENTAL: Oral semaglutide formulation B; Participants will receive oral semaglutide formulation B for 10 days.	Drug: Semaglutide B 3 mg; Semaglutide B 3 mg will be administered OD orally in the morning from day 1 to 5.; Drug: Semaglutide B 7 mg; Semaglutide B 7 mg will be administered OD orally in the morning from day 6 to 10.
EXPERIMENTAL: Oral semaglutide formulation C; Participants will receive oral semaglutide formulation C for 10 days.	Drug: Semaglutide C 3 mg; Semaglutide C 3 mg will be administered OD orally in the morning from day 1 to 5.; Drug: Semaglutide C 7 mg; Semaglutide C 7 mg will be administered OD orally in the morning from day 6 to 10.
EXPERIMENTAL: Oral semaglutide formulation D; Participants will receive oral semaglutide formulation D for 10 days.	Drug: Semaglutide D 3 mg; Semaglutide D 3 mg will be administered OD orally in the morning from day 1 to 5.; Drug: Semaglutide D 7 mg; Semaglutide D 7 mg will be administered OD orally in the morning from day 6 to 10.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-24h,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 24 hours after the 10th dosing	Calculated based on semaglutide measured in blood.	0 to 24 hours on day 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax,sema,day10, maximum observed semaglutide plasma concentration from 0 to 24 hours after the 10th dosing	Calculated based on semaglutide measured in blood.	0 to 24 hours on day 10
tmax,sema,day10, time to maximum observed semaglutide plasma concentration from 0 to 24 hours after the 10th dosing	Calculated based on semaglutide measured in blood.	0 to 24 hours on day 10
AUC0-30min,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 30 minutes after the 10th dosing	Calculated based on semaglutide measured in blood.	0 to 30 minutes on day 10
t½,sema,day10, terminal half-life of semaglutide up to 35 days after the 10th dosing	Calculated based on semaglutide measured in blood. Measured from the 10th. dosing (on Day 10) and up to 35 days after the 10th. dosing (i.e. Day 45).	Days 10-45
Number of treatment emergent adverse events	Count of events.	Days 1-47

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 17, 2018
• Primary Completion (ACTUAL): December 5, 2018
• Study Completion (ACTUAL): December 5, 2018

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 17, 2018
• First Posted (ACTUAL): August 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2019
• Last Update Submitted That Met QC Criteria: November 13, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NN9924-4427; U1111-1206-6210 (OTHER: World Health Organization (WHO)); 2017-005023-24 (REGISTRY: European Medicines Agency (EudraCT))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes