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NCT Number: NCT03638778

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Semaglutide 3 mg

Drug

Semaglutide 3 mg will be administered once daily (OD) orally in the morning from day 1 to 5.

Semaglutide 7 mg

Drug

Semaglutide 7 mg will be administered OD orally in the morning from day 6 to 10.

Semaglutide B 3 mg

Drug

Semaglutide B 3 mg will be administered OD orally in the morning from day 1 to 5.

Semaglutide B 7 mg

Drug

Semaglutide B 7 mg will be administered OD orally in the morning from day 6 to 10.

Semaglutide C 3 mg

Drug

Semaglutide C 3 mg will be administered OD orally in the morning from day 1 to 5.

Semaglutide C 7 mg

Drug

Semaglutide C 7 mg will be administered OD orally in the morning from day 6 to 10.

Semaglutide D 3 mg

Drug

Semaglutide D 3 mg will be administered OD orally in the morning from day 1 to 5.

Semaglutide D 7 mg

Drug

Semaglutide D 7 mg will be administered OD orally in the morning from day 6 to 10.

Primary outcomes

  1. AUC0-24h,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 24 hours after the 10th dosing

    Time frame: 0 to 24 hours on day 10

    Calculated based on semaglutide measured in blood.

Secondary outcomes

  1. Cmax,sema,day10, maximum observed semaglutide plasma concentration from 0 to 24 hours after the 10th dosing

    Time frame: 0 to 24 hours on day 10

    Calculated based on semaglutide measured in blood.

  2. tmax,sema,day10, time to maximum observed semaglutide plasma concentration from 0 to 24 hours after the 10th dosing

    Time frame: 0 to 24 hours on day 10

    Calculated based on semaglutide measured in blood.

  3. AUC0-30min,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 30 minutes after the 10th dosing

    Time frame: 0 to 30 minutes on day 10

    Calculated based on semaglutide measured in blood.

  4. t½,sema,day10, terminal half-life of semaglutide up to 35 days after the 10th dosing

    Time frame: 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).

  5. Number of treatment emergent adverse events

    Time frame: Days 1-47

    Count of events.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 20, 2018
Registry last updated
Nov 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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