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

• ClinicalTrials.gov Identifier: NCT03617081
• Recruitment Status: Completed
• First Posted: August 6, 2018
• Last Update Posted: January 10, 2020
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

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.

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

Study Design

• 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 13, 2018
• Actual Study Completion Date: December 13, 2018

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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).

Contacts and Locations

Locations

United States, Texas

Novo Nordisk Investigational Site

San Antonio, Texas, United States, 78209

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

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

More Information

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT03617081
• Other Study ID Numbers: NN9023-4408; U1111-1209-3837 ( Other Identifier: World Health Organization (WHO) )
• First Posted: August 6, 2018
• Last Update Posted: January 10, 2020
• Last Verified: January 2020

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

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases