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NNC0113-6861

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04676906A Study Investigating the Distribution and Metabolism of Three 14C-labeled Radioactive Study CompoundsPHASE1 COMPLETED 18Nov 26, 2020Apr 28, 2021Apr 27, 20231 Netherlands
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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 — 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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