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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

NNC0113-2023

Placebo (NNC0113-2023)

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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).

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NNC0113-2023

Placebo

Arm Description

Participants will receive increasing doses of NNC0113-2023 on day 1. Each participant will receive only a single dose.

Participants will receive placebo (NNC0113-2023)

Outcomes

Primary Outcome Measures

Number of treatment emergent adverse events (TEAEs)

Count of events

Secondary Outcome Measures

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

Measured in nmol/L*h

Cmax,2023,SD; the maximum plasma concentration of NNC0113-2023 after a single dose of oral NNC0113-2023

Measured in nmol/L

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

Measured in ng/mL*h

Cmax,SNAC,SD; the maximum plasma concentration of SNAC in plasma after a single dose of oral NNC0113-2023

Measured in ng/mL

Full Information

NCT ID

NCT03617081

First Posted

August 1, 2018

Last Updated

January 8, 2020

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT03617081

Brief Title

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

Official Title

A First Human Dose Trial Investigating the Safety, Tolerability and Pharmacokinetics of Single Doses of Oral NNC0113-2023 in Healthy Male Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

August 9, 2018 (Actual)

Primary Completion Date

December 13, 2018 (Actual)

Study Completion Date

December 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NNC0113-2023

Arm Type

Experimental

Arm Description

Participants will receive increasing doses of NNC0113-2023 on day 1. Each participant will receive only a single dose.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants will receive placebo (NNC0113-2023)

Intervention Type

Drug

Intervention Name(s)

NNC0113-2023

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo (NNC0113-2023)

Intervention Description

Participants will receive NNC0174-0833 matched placebo orally.

Primary Outcome Measure Information:

Title

Number of treatment emergent adverse events (TEAEs)

Description

Count of events

Time Frame

From time of dosing (day 1) until completion of the follow-up visit (day 43)

Secondary Outcome Measure Information:

Title

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

Description

Measured in nmol/L*h

Time Frame

From baseline (day 1) to post treatment follow-up (day 43)

Title

Cmax,2023,SD; the maximum plasma concentration of NNC0113-2023 after a single dose of oral NNC0113-2023

Description

Measured in nmol/L

Time Frame

From baseline (day 1) to post treatment follow-up (day 43)

Title

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

Description

Measured in ng/mL*h

Time Frame

From baseline (day 1) to 24 hours after dosing

Title

Cmax,SNAC,SD; the maximum plasma concentration of SNAC in plasma after a single dose of oral NNC0113-2023

Description

Measured in ng/mL

Time Frame

From baseline (day 1) to 24 hours after dosing

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Reporting Anchor and Disclosure (1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78209

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

IPD Sharing URL

http://novonordisk-trials.com

Learn more about this trial

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

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