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
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: NNC0113-2023 Drug: Placebo (NNC0113-2023)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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)
Drug: Placebo (NNC0113-2023)
Participants will receive NNC0174-0833 matched placebo orally.
- 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
- 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
- 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
- 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
- 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
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
|United States, Texas|
|Novo Nordisk Investigational Site|
|San Antonio, Texas, United States, 78209|
|Study Director:||Clinical Reporting Anchor and Disclosure (1452)||Novo Nordisk A/S|