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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 is a Phase 1 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 40 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03617081
The ClinicalTrials.gov registry entry for NCT03617081 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which NNC0113-2023 is the first listed.
NCT03617081 reports 0 study locations.
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.
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