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NCT03617081 · ClinicalTrials.gov registry record · Phase 1
First Research Study of the Possible New Medicine NNC0113-2023 in Healthy Men.
A Phase 1 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT03617081: Completed Phase 1 study, sponsored by Novo Nordisk A/S.
NCT03617081 is a Phase 1 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03617081, a Phase 1 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
Count of events
Interventions
- DRUG NNC0113-2023
- DRUG Placebo (NNC0113-2023)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-08-09 |
| Est. Completion | 2018-12-13 |
| Phase | Phase 1 |
What the finished NCT03617081 record still lists
NCT03617081 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which NNC0113-2023 is the first listed.
NCT03617081 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03617081 about?
NCT03617081 is a clinical study titled "First Research Study of the Possible New Medicine NNC0113-2023 in Healthy Men.". 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 NNC0113-202...
What is the current status of trial NCT03617081?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2018-08-09. Estimated completion is 2018-12-13.
What interventions are being tested in trial NCT03617081?
The interventions under investigation include: NNC0113-2023 (DRUG), Placebo (NNC0113-2023) (DRUG).
Who is sponsoring clinical trial NCT03617081?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03617081's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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