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

NCT03617081 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-01-10

No results posted yet for this 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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

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.

DRUG

Placebo (NNC0113-2023)

Participants will receive NNC0174-0833 matched placebo orally.

Sponsors & Collaborators

Principal Investigators

  • Clinical Reporting Anchor and Disclosure (1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-09
Primary Completion
2018-12-13
Completion
2018-12-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03617081 on ClinicalTrials.gov