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OpenTrials
Completed

NCT Number: NCT04531150

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.

Completed

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Key information

Conditions

Pharmacokinetic

Age range

15 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences

Montreal, Quebec, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

INV-101

Drug

Subjects will be randomized to receive INV-101 tablets

Placebo

Drug

Subjects will be randomized to receive placebo tablets

Primary outcomes

  1. Pharmacokinetic parameters - Maximum Concentration (Cmax)

    Time frame: 72 hours

    Cmax following single dose

  2. Pharmacokinetic parameters - AUC

    Time frame: 72 hours

    AUC following single dose

  3. Pharmacokinetic parameters - Half-live

    Time frame: 72 hours

    Half-live following single dose

Secondary outcomes

  1. Adverse events

    Time frame: 72 hours

    Safety of INV-101 following single dose

Sponsors and collaborators

Lead sponsor

Inversago Pharma Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 28, 2020
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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