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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

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment152

FDA Designations

No designations recorded

Clinical trial landscape

NNC0385 · 1 trial · 1 indication

Phase 1 1
NCT05333107A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation IIHealthy Volunteers; High Cholesterol
COMPLETED152 Analytics
PHASE1COMPLETED
A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation II
Healthy Volunteers; High CholesterolUnlock trial analytics

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 to 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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Frequently asked questions about NNC0385

What is NNC0385 used for?

NNC0385 is an investigational small molecule being developed for high cholesterol. It is currently in Phase 1 clinical development, studied in healthy volunteers and individuals with high cholesterol. The drug is being evaluated as a protein-based tablet formulation.

Who makes NNC0385?

NNC0385 is being developed by Novo Nordisk A/S, a biopharmaceutical company traded on the stock exchange under the ticker NVO. The company is conducting clinical research on this investigational drug for the treatment of high cholesterol.

What phase is NNC0385 in?

NNC0385 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 completed Phase 1 trial involving healthy volunteers and participants with high cholesterol.

What clinical trials is NNC0385 in?

NNC0385 has one completed clinical trial registered as NCT05333107, titled "A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation II." This Phase 1 study enrolled 152 male participants aged 18 years and older in the United States.

Is NNC0385 the same as a protein-based tablet?

NNC0385 is being studied as a protein-based tablet formulation. The clinical trial NCT05333107 specifically evaluates this oral formulation in healthy men. The drug is a small molecule, and the research focuses on its use for high cholesterol.