Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of INV-101 in Healthy Male and Female Subjects

A Single Center, Phase I, Double-Blind, Placebo-Controlled Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of INV-101 in Healthy Male and Female Subjects

Single center, randomized, double-blinded, placebo-controlled, single ascending-dose study for the evaluation of the safety, tolerability, and PK following single oral doses of INV-101.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetic
• Intervention / Treatment: Drug: INV-101; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada
      • Altasciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 physical examination (including vital signs) and/or ECG, as determined by an investigator

Exclusion Criteria:

• Female who is pregnant or lactating
• Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability
• History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
• Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment (maximum QTc of 450 for males and 470 for females)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Subjects will be randomized to receive either placebo or 20 mg INV-101	Drug: INV-101; Subjects will be randomized to receive INV-101 tablets; Drug: Placebo; Subjects will be randomized to receive placebo tablets
Experimental: Cohort 2; Subjects will be randomized to receive either placebo or 80 mg INV-101	Drug: INV-101; Subjects will be randomized to receive INV-101 tablets; Drug: Placebo; Subjects will be randomized to receive placebo tablets
Experimental: Cohort 3; Subjects will be randomized to receive either placebo or 160 mg INV-101	Drug: INV-101; Subjects will be randomized to receive INV-101 tablets; Drug: Placebo; Subjects will be randomized to receive placebo tablets
Experimental: Cohort 4; Subjects will be randomized to receive either placebo or 320 mg INV-101	Drug: INV-101; Subjects will be randomized to receive INV-101 tablets; Drug: Placebo; Subjects will be randomized to receive placebo tablets
Experimental: Cohort 5; Subjects will be randomized to receive either placebo or 500 mg INV-101	Drug: INV-101; Subjects will be randomized to receive INV-101 tablets; Drug: Placebo; Subjects will be randomized to receive placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic parameters - Maximum Concentration (Cmax)	Cmax following single dose	72 hours
Pharmacokinetic parameters - AUC	AUC following single dose	72 hours
Pharmacokinetic parameters - Half-live	Half-live following single dose	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Safety of INV-101 following single dose	72 hours

Collaborators and Investigators

• Sponsor: Inversago Pharma Inc.
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2020
• Primary Completion (Actual): January 16, 2021
• Study Completion (Actual): May 16, 2021

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: INV101-CL-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No