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

Pharmacokinetic Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04531150
• Other study ID #: INV101-CL-101
• Status: Completed
• Phase: Phase 1
• Start date: September 8, 2020
• Est. completion date: May 16, 2021

Study information

• Verified date: June 2021
• Source: Inversago Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 16, 2021
• Est. primary completion date: January 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pharmacokinetic

Intervention

Drug:
• INV-101
Subjects will be randomized to receive INV-101 tablets
• Placebo
Subjects will be randomized to receive placebo tablets

Locations

Country	Name	City	State
Canada	Altasciences	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Inversago Pharma Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters - Maximum Concentration (Cmax)	Cmax following single dose	72 hours
Primary	Pharmacokinetic parameters - AUC	AUC following single dose	72 hours
Primary	Pharmacokinetic parameters - Half-live	Half-live following single dose	72 hours
Secondary	Adverse events	Safety of INV-101 following single dose	72 hours