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

NCT04531150 | Completed Phase 1

• 1 other identifier: INV101-CL-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetic

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Adverse events

  72 hours

Study Arms (5)

Cohort 1

EXPERIMENTAL

Subjects will be randomized to receive either placebo or 20 mg INV-101

Drug: INV-101; Drug: Placebo

Cohort 2

EXPERIMENTAL

Subjects will be randomized to receive either placebo or 80 mg INV-101

Drug: INV-101; Drug: Placebo

Cohort 3

EXPERIMENTAL

Subjects will be randomized to receive either placebo or 160 mg INV-101

Drug: INV-101; Drug: Placebo

Cohort 4

EXPERIMENTAL

Subjects will be randomized to receive either placebo or 320 mg INV-101

Drug: INV-101; Drug: Placebo

Cohort 5

EXPERIMENTAL

Subjects will be randomized to receive either placebo or 500 mg INV-101

Drug: INV-101; Drug: Placebo

Interventions

INV-101 DRUG

Subjects will be randomized to receive INV-101 tablets

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Placebo DRUG

Subjects will be randomized to receive placebo tablets

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Inversago Pharma Inc.: lead

Study Sites (1)

Altasciences

Montreal, Quebec, Canada

Location

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Fully blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 28, 2020
• Study Start: September 8, 2020
• Primary Completion: January 16, 2021
• Study Completion: May 16, 2021
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)