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INV-101

Phase 1

Undisclosed | Small molecule | Other |Novo Nordisk A/S|Trials Updated: Mar 30, 2025

INV-101 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

INV-101 clinical trials

INV-101 · 1 trial · 1 indication

Phase 1 1
NCT04531150Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of INV-101 in Healthy Male and Female SubjectsPharmacokinetic
COMPLETED40 Analytics
PHASE1COMPLETED
Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of INV-101 in Healthy Male and Female Subjects
PharmacokineticUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetic parameters - Maximum Concentration (Cmax)
72 hours

Cmax following single dose

Pharmacokinetic parameters - AUC
72 hours

AUC following single dose

Pharmacokinetic parameters - Half-live
72 hours

Half-live following single dose

Secondary Endpoints

Adverse events
72 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALSubjects will be randomized to receive either placebo or 20 mg INV-101
Cohort 2EXPERIMENTALSubjects will be randomized to receive either placebo or 80 mg INV-101
Cohort 3EXPERIMENTALSubjects will be randomized to receive either placebo or 160 mg INV-101
Cohort 4EXPERIMENTALSubjects will be randomized to receive either placebo or 320 mg INV-101
Cohort 5EXPERIMENTALSubjects will be randomized to receive either placebo or 500 mg INV-101

Interventions

NameTypeDescription
INV-101DRUGSubjects will be randomized to receive INV-101 tablets
PlaceboDRUGSubjects will be randomized to receive placebo tablets
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Eligibility Criteria

Age Range15 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy adult male or female * Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively; and body weight ≥60 kg * Non- or ex-smoker * Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physica...

Countries:Canada
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Frequently asked questions about INV-101

What is INV-101?

INV-101 is an investigational small molecule developed by Novo Nordisk A/S. It has been studied in a Phase 1 clinical trial evaluating its safety, tolerability, and pharmacokinetics in healthy adult volunteers. The specific disease or condition INV-101 is intended to treat has not been disclosed.

Who makes INV-101?

INV-101 is being developed by Novo Nordisk A/S, which trades on the New York Stock Exchange under the ticker NVO. Novo Nordisk is the sponsor of the clinical program for this investigational small molecule.

What phase is INV-101 in?

INV-101 is in Phase 1 clinical development. Its single recorded trial, NCT04531150, has been completed. The study was a Phase 1 trial, and no later-stage trials have been registered, so INV-101 remains an investigational drug rather than an approved therapy.

What clinical trials is INV-101 in?

INV-101 has been studied in one clinical trial, NCT04531150, titled "Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of INV-101 in Healthy Male and Female Subjects." The Phase 1 trial enrolled 40 healthy volunteers in Canada and is now completed.

How was the INV-101 Phase 1 trial designed?

The INV-101 Phase 1 trial, NCT04531150, was a randomized, double-blind, controlled study of single ascending oral doses in healthy male and female subjects. It enrolled 40 participants at sites in Canada, included subjects aged 15 years and older, and has been completed.