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INV-101

Phase 1

Pharmacokinetic | Small molecule | Other |Novo Nordisk A/S|Last Updated: Mar 30, 2025

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

Clinical trial landscape

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 being developed by Novo Nordisk A/S (NVO). It is currently in Phase 1 clinical development. The drug is being studied for its pharmacokinetic properties, meaning how the body absorbs, distributes, metabolizes, and excretes the drug.

What is INV-101 used for?

INV-101 is being studied for pharmacokinetic purposes, which involves understanding how the drug behaves in the body. It is not being developed for a specific disease indication at this stage. The drug is in early clinical development to assess its safety, tolerability, and pharmacokinetics in healthy subjects.

Who makes INV-101?

INV-101 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 safety, tolerability, and pharmacokinetics in healthy volunteers.

What phase is INV-101 in?

INV-101 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. It is being studied in early-stage clinical trials to evaluate its safety, tolerability, and pharmacokinetic profile in healthy subjects.

What clinical trials is INV-101 in?

INV-101 has one completed clinical trial, identified as NCT04531150. This was a Phase 1 study titled "Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of INV-101 in Healthy Male and Female Subjects." The trial enrolled 40 participants in Canada and was a randomized, double-blind, controlled study.

Is INV-101 FDA approved?

INV-101 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug is being studied in clinical trials to evaluate its safety, tolerability, and pharmacokinetics, but it has not yet received regulatory approval for any use.