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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04531150

Enrollment

Registered

2020-08-28

Start date

2020-09-08

Completion date

2021-05-16

Last updated

2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetic

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.

Interventions

DRUGINV-101

Subjects will be randomized to receive INV-101 tablets

DRUGPlacebo

Subjects will be randomized to receive placebo tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Fully blinded

Eligibility

Sex/Gender

ALL

Age

15 Years to 55 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026