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First Research Study of the Possible New Medicine NNC0113-2023 in Healthy Men.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03617081
Recruitment Status : Completed
First Posted : August 6, 2018
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
The aim of this study is to assess how safe the study drug is and how well a participant tolerates it after a single oral (taken by mouth) dose. The study also aims to measure the concentration of the study drug and its breakdown products after a single dose. Participants will either get NNC0113-2023 (a new medicine) or placebo (a "dummy medicine similar to the study medicine but without active ingredients) - which treatment any participant gets is decided by chance. Participants will get one dose (can be one or two tablets) of study medicine. The study will last for about 65 days. Participants will have 10 scheduled site visits with the study physician or study staff at the study centre. For one of the visits, participants will stay at the research unit for 5 days. At all visits, except the first information visit, participants will have blood drawn along with other clinical assessments. Participants cannot take part in this study if participants have any disorder that the doctor thinks is a health problem. Only healthy men are allowed to take part.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: NNC0113-2023 Drug: Placebo (NNC0113-2023) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A First Human Dose Trial Investigating the Safety, Tolerability and Pharmacokinetics of Single Doses of Oral NNC0113-2023 in Healthy Male Subjects
Actual Study Start Date : August 9, 2018
Actual Primary Completion Date : December 5, 2018
Actual Study Completion Date : December 5, 2018

Arm Intervention/treatment
Experimental: NNC0113-2023
Participants will receive increasing doses of NNC0113-2023 on day 1. Each participant will receive only a single dose.
Drug: NNC0113-2023
Participants will receive dose levels of 1 mg, 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of NNC0113-2023 orally. Each participant will receive only one dose.

Placebo Comparator: Placebo
Participants will receive placebo (NNC0113-2023)
Drug: Placebo (NNC0113-2023)
Participants will receive NNC0174-0833 matched placebo orally.




Primary Outcome Measures :
  1. Number of treatment emergent adverse events (TEAEs) [ Time Frame: From time of dosing (day 1) until completion of the follow-up visit (day 43) ]
    Count of events


Secondary Outcome Measures :
  1. AUC0-∞,2023,SD; the area under the NNC0113-2023 plasma concentration-time curve from time 0 to infinity after a single dose of oral NNC0113-2023 [ Time Frame: From baseline (day 1) to post treatment follow-up (day 43) ]
    Measured in nmol/L*h

  2. Cmax,2023,SD; the maximum plasma concentration of NNC0113-2023 after a single dose of oral NNC0113-2023 [ Time Frame: From baseline (day 1) to post treatment follow-up (day 43) ]
    Measured in nmol/L

  3. AUC0-24h,SNAC,SD; the area under the SNAC plasma concentration-time curve from time 0 to 24 hours after a single dose of oral NNC0113-2023 [ Time Frame: From baseline (day 1) to 24 hours after dosing ]
    Measured in ng/mL*h

  4. Cmax,SNAC,SD; the maximum plasma concentration of SNAC in plasma after a single dose of oral NNC0113-2023 [ Time Frame: From baseline (day 1) to 24 hours after dosing ]
    Measured in ng/mL



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male aged 18 - 45 years (both inclusive) at the time of signing informed consent.
  • Body mass index between 20.0 kg/m^2 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:

  • 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: 1) Smoking more than 1 cigarettes or the equivalent per day or 2) Not willing to refrain from smoking and use of nicotine substitute products during the in-house period.
  • 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.
  • Presence or history of pancreatitis (acute or chronic).

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): NCT03617081


Locations
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United States, Texas
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03617081     History of Changes
Other Study ID Numbers: NN9023-4408
U1111-1209-3837 ( Other Identifier: World Health Organization (WHO) )
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases