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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03638778
• Other study ID #: NN9924-4427
• Secondary ID: U1111-1206-62102
• Status: Completed
• Phase: Phase 1
• Start date: August 17, 2018
• Est. completion date: December 5, 2018

Study information

• Verified date: November 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 5, 2018
• Est. primary completion date: December 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Semaglutide 3 mg
Semaglutide 3 mg will be administered once daily (OD) orally in the morning from day 1 to 5.
• Semaglutide 7 mg
Semaglutide 7 mg will be administered OD orally in the morning from day 6 to 10.
• Semaglutide B 3 mg
Semaglutide B 3 mg will be administered OD orally in the morning from day 1 to 5.
• Semaglutide B 7 mg
Semaglutide B 7 mg will be administered OD orally in the morning from day 6 to 10.
• Semaglutide C 3 mg
Semaglutide C 3 mg will be administered OD orally in the morning from day 1 to 5.
• Semaglutide C 7 mg
Semaglutide C 7 mg will be administered OD orally in the morning from day 6 to 10.
• Semaglutide D 3 mg
Semaglutide D 3 mg will be administered OD orally in the morning from day 1 to 5.
• Semaglutide D 7 mg
Semaglutide D 7 mg will be administered OD orally in the morning from day 6 to 10.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of treatment emergent adverse events	Count of events.	Days 1-47