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NNC0385-

Phase 1

Healthy Volunteers; High Cholesterol | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Jul 12, 2024

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment152
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05333107A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation IIPHASE1 COMPLETED 152 — — Apr 12, 2022Sep 23, 2022Jul 12, 20242 United States
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Study Endpoints
Primary Endpoints
AUC0-24h,NNC0385-0434,day10; area under the plasma concentrationtime curve during a dosing interval
From 0 to 24 hours after dose administration on visit 2, day 10

Measured in h \* nmol/L

Secondary Endpoints
Cmax,NNC0385-0434,day10; maximum observed plasma concentration of NNC0385-0434
From 0 to 24 hours after dose administration on visit 2, day 10
tmax,NNC0385-0434,day10; time from dose administration to maximum observed plasma concentration of NNC0385- 0434
From 0 to 24 hours after dose administration on visit 2, day 10
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sequence 1EXPERIMENTALParticipants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2).
Sequence 2EXPERIMENTALParticipants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2).
Sequence 3EXPERIMENTALParticipants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2).
Sequence 4EXPERIMENTALParticipants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2).
Sequence 5EXPERIMENTALParticipants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2).
Sequence 6EXPERIMENTALParticipants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2).
Interventions
NameTypeDescription
NNC0385-0434 GDRUGParticipants will receive oral dose of NNC0385-0434 G tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).
NNC0385-0434 FDRUGParticipants will receive oral dose of NNC0385-0434 F tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).
NNC0385-0434 BDRUGParticipants will receive oral dose of NNC0385-0434 B tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).
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Eligibility Criteria
Age Range18 Years — 64 Years
SexMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Male * Aged 18-64 years (both inclusive) at the time of signing informed consent * Body mass index between 20.0 and 32.0 kilogram per meter square (both inclusive) * Considered to be generally healthy based on the medical history, physical examination, and the results of vital...

Countries:United States
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