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

Phase 1

Completed

• Conditions: Pharmacokinetic
• Interventions: Drug: INV-101; Drug: Placebo

• Registration Number: NCT04531150
• Lead Sponsor: Inversago Pharma Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-24
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-28
• Study Start: 2020-09-08
• Primary Completion: 2021-01-16
• Study Completion: 2021-05-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	Placebo	Subjects will be randomized to receive either placebo or 20 mg INV-101
Cohort 4	INV-101	Subjects will be randomized to receive either placebo or 320 mg INV-101
Cohort 5	INV-101	Subjects will be randomized to receive either placebo or 500 mg INV-101
Cohort 1	INV-101	Subjects will be randomized to receive either placebo or 20 mg INV-101
Cohort 2	INV-101	Subjects will be randomized to receive either placebo or 80 mg INV-101
Cohort 2	Placebo	Subjects will be randomized to receive either placebo or 80 mg INV-101
Cohort 3	INV-101	Subjects will be randomized to receive either placebo or 160 mg INV-101
Cohort 4	Placebo	Subjects will be randomized to receive either placebo or 320 mg INV-101
Cohort 3	Placebo	Subjects will be randomized to receive either placebo or 160 mg INV-101
Cohort 5	Placebo	Subjects will be randomized to receive either placebo or 500 mg INV-101

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Adverse events	72 hours	Safety of INV-101 following single dose

Trial Locations

Locations (1)

Altasciences; 🇨🇦 Montreal, Quebec, Canada