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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Semaglutide C 3 mg; Drug: Semaglutide 3 mg; Drug: Semaglutide B 3 mg; Drug: Semaglutide D 3 mg; Drug: Semaglutide B 7 mg; Drug: Semaglutide C 7 mg; Drug: Semaglutide D 7 mg; Drug: Semaglutide 7 mg

• Registration Number: NCT03638778
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-08
• Study Start: 2018-08-17
• Study First Submitted QC: 2018-08-17
• Study First Posted: 2018-08-20
• Primary Completion: 2018-12-05
• Study Completion: 2018-12-05
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-13
• Last Update Posted: 2019-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 105

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral semaglutide formulation B	Semaglutide B 7 mg	Participants will receive oral semaglutide formulation B for 10 days.
Oral semaglutide formulation C	Semaglutide C 3 mg	Participants will receive oral semaglutide formulation C for 10 days.
Oral semaglutide formulation C	Semaglutide C 7 mg	Participants will receive oral semaglutide formulation C for 10 days.
Oral semaglutide formulation D	Semaglutide D 7 mg	Participants will receive oral semaglutide formulation D for 10 days.
Oral semaglutide (reference)	Semaglutide 3 mg	Participants will receive oral semaglutide (reference) for 10 days.
Oral semaglutide (reference)	Semaglutide 7 mg	Participants will receive oral semaglutide (reference) for 10 days.
Oral semaglutide formulation B	Semaglutide B 3 mg	Participants will receive oral semaglutide formulation B for 10 days.
Oral semaglutide formulation D	Semaglutide D 3 mg	Participants will receive oral semaglutide formulation D for 10 days.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Berlin, Germany