- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03617081
First Research Study of the Possible New Medicine NNC0113-2023 in Healthy Men.
January 8, 2020 updated by: Novo Nordisk A/S
A First Human Dose Trial Investigating the Safety, Tolerability and Pharmacokinetics of Single Doses of Oral NNC0113-2023 in Healthy Male Subjects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78209
- Novo Nordisk Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
|
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)
|
Participants will receive NNC0174-0833 matched placebo orally.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From time of dosing (day 1) until completion of the follow-up visit (day 43)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From baseline (day 1) to post treatment follow-up (day 43)
|
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
|
From baseline (day 1) to post treatment follow-up (day 43)
|
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
|
From baseline (day 1) to 24 hours after dosing
|
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
|
From baseline (day 1) to 24 hours after dosing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 9, 2018
Primary Completion (Actual)
December 13, 2018
Study Completion (Actual)
December 13, 2018
Study Registration Dates
First Submitted
August 1, 2018
First Submitted That Met QC Criteria
August 1, 2018
First Posted (Actual)
August 6, 2018
Study Record Updates
Last Update Posted (Actual)
January 10, 2020
Last Update Submitted That Met QC Criteria
January 8, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN9023-4408
- U1111-1209-3837 (Other Identifier: World Health Organization (WHO))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
AstraZenecaRecruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRecruitingType 2 Diabetes Mellitus (T2DM)China
Clinical Trials on NNC0113-2023
-
Novo Nordisk A/SCompletedType 2 Diabetes | Healthy VolunteersNetherlands
-
Novo Nordisk A/SRecruiting
-
Novo Nordisk A/SCompleted
-
Novo Nordisk A/SCompletedType 2 Diabetes | Healthy VolunteersGermany
-
Novo Nordisk A/SCompletedHealthy | Diabetes Mellitus, Type 2 | DiabetesUnited Kingdom
-
Novo Nordisk A/SCompletedHealthy | DiabetesUnited Kingdom
-
Promentis Pharmaceuticals, Inc.CompletedHealthy VolunteersUnited States
-
Promentis Pharmaceuticals, Inc.Completed
-
Novo Nordisk A/SCompleted
-
Promentis Pharmaceuticals, Inc.CelerionCompleted