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

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

Tracking Information

• First Submitted Date: August 8, 2018
• First Posted Date: August 20, 2018
• Last Update Posted Date: November 14, 2019
• Actual Study Start Date: August 17, 2018
• Actual Primary Completion Date: December 5, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 17, 2018)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 17, 2018)

• 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.
• 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.
• 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.
• 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).
• Number of treatment emergent adverse events [ Time Frame: Days 1-47 ]
  Count of events.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Research Study Comparing Different Tablets With the Study Medicine Semaglutide in Healthy Men
• Official Title: A Trial Comparing Exposure of Semaglutide When Dosing New Formulations of Oral Semaglutide to Healthy Male Subjects
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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.
• Drug: Semaglutide 7 mg
  Semaglutide 7 mg will be administered OD orally in the morning from day 6 to 10.
• 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.
• 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.
• 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.

Study Arms

• Active Comparator: Oral semaglutide (reference)
  Participants will receive oral semaglutide (reference) for 10 days.
  Interventions:

  • Drug: Semaglutide 3 mg
  • Drug: Semaglutide 7 mg
• Experimental: Oral semaglutide formulation B
  Participants will receive oral semaglutide formulation B for 10 days.
  Interventions:

  • Drug: Semaglutide B 3 mg
  • Drug: Semaglutide B 7 mg
• Experimental: Oral semaglutide formulation C
  Participants will receive oral semaglutide formulation C for 10 days.
  Interventions:

  • Drug: Semaglutide C 3 mg
  • Drug: Semaglutide C 7 mg
• Experimental: Oral semaglutide formulation D
  Participants will receive oral semaglutide formulation D for 10 days.
  Interventions:

  • Drug: Semaglutide D 3 mg
  • Drug: Semaglutide D 7 mg

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 7, 2018): 105
• Original Estimated Enrollment (submitted: August 17, 2018): 104
• Actual Study Completion Date: December 5, 2018
• Actual Primary Completion Date: December 5, 2018 (Final data collection date for primary outcome measure)
• Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: 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) )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

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

• Current Responsible Party: Novo Nordisk A/S
• Original Responsible Party: Same as current
• Current Study Sponsor: Novo Nordisk A/S
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Reporting Anchor and Disclosure (1452); Novo Nordisk A/S

• PRS Account: Novo Nordisk A/S
• Verification Date: November 2019