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NNC0113-6861

Phase 1

Healthy Volunteers | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Apr 27, 2023

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

NNC0113-6861 · 1 trial · 2 indications

Phase 1 1
NCT04676906A Study Investigating the Distribution and Metabolism of Three 14C-labeled Radioactive Study CompoundsHealthy Volunteers
COMPLETED18 Analytics
PHASE1COMPLETED
A Study Investigating the Distribution and Metabolism of Three 14C-labeled Radioactive Study Compounds
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Study Endpoints

Primary Endpoints

The apparent elimination half-life of each of the 3 study compounds and their active metabolite after a single iv dose of each of the 3 study compounds
From time of first dosing (Day 1) until Day 64

hours

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Study compound 1EXPERIMENTALUp to 6 volunteers will receive one dose of study compound 1
Study compound 2EXPERIMENTALUp to 6 volunteers will receive one dose of study compound 2
Study compound 3EXPERIMENTALUp to 6 volunteers will receive one dose of study compound 3

Interventions

NameTypeDescription
NNC0113-6861DRUGStudy compound 1 - Each participant will receive a single intravenous (i.v) dose of \[14C\]-NNC0113-6861
NNC0113-6860DRUGStudy compound 2 - Each participant will receive a single i.v dose of \[14C\]-NNC0113-6860
NNC0113-6891DRUGStudy compound 3 - Each participant will receive a single i.v dose of \[14C\]-NNC0113-6891
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Eligibility Criteria

Age Range18 Years to 54 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy subject. * Sex : Male. * Age 18 to 54 years, inclusive, at the time of signing informed consent. * Body mass index (BMI) 18.0 to 30.0 kg/m\^2, inclusive, at the time of signing informed consent . Exclusion Criteria: * Known or suspected hypersensitivity to study prod...

Countries:Netherlands
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Frequently asked questions about NNC0113-6861

What is NNC0113-6861 used for?

NNC0113-6861 is an investigational small molecule being developed by Novo Nordisk for metabolic conditions. It is currently in Phase 1 clinical development, studied in healthy volunteers and individuals with Type 2 Diabetes. The drug is not yet approved and remains in early-stage clinical testing.

Who makes NNC0113-6861?

NNC0113-6861 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate the drug's properties in healthy volunteers and people with Type 2 Diabetes.

What phase is NNC0113-6861 in?

NNC0113-6861 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in a single completed Phase 1 trial involving 18 participants, with no active trials currently ongoing.

What clinical trials is NNC0113-6861 in?

NNC0113-6861 has one completed clinical trial, registered as NCT04676906. This Phase 1 study investigated the distribution and metabolism of three 14C-labeled radioactive study compounds, including NNC0113-6861, in healthy male volunteers and individuals with Type 2 Diabetes. The trial was conducted in the Netherlands.

Is NNC0113-6861 the same as any other drug?

No alternative names for NNC0113-6861 have been disclosed. The drug is identified solely by its code name NNC0113-6861 in clinical trial registrations and development records.