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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04531150
Other study ID # INV101-CL-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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