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

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ClinicalTrials.gov Identifier: NCT03638778
Recruitment Status : Completed
First Posted : August 20, 2018
Last Update Posted : November 14, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 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 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial Comparing Exposure of Semaglutide When Dosing New Formulations of Oral Semaglutide to Healthy Male Subjects
Actual Study Start Date : August 17, 2018
Actual Primary Completion Date : December 5, 2018
Actual Study Completion Date : December 5, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638778


Locations
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Germany
Novo Nordisk Investigational Site
Berlin, Germany, 14050
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03638778    
Other Study ID Numbers: NN9924-4427
U1111-1206-6210 ( Other Identifier: World Health Organization (WHO) )
2017-005023-24 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com/sharing-results

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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
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases