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

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ClinicalTrials.gov Identifier: NCT04531150
Recruitment Status : Completed
First Posted : August 28, 2020
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Inversago Pharma Inc.

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.

Condition or disease Intervention/treatment Phase
Pharmacokinetic Drug: INV-101 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Fully blinded
Primary Purpose: Treatment
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
Actual Study Start Date : September 8, 2020
Actual Primary Completion Date : January 16, 2021
Actual Study Completion Date : May 16, 2021

Arm Intervention/treatment
Experimental: Cohort 1
Subjects will be randomized to receive either placebo or 20 mg INV-101
Drug: INV-101
Subjects will be randomized to receive INV-101 tablets

Drug: Placebo
Subjects will be randomized to receive placebo tablets

Experimental: Cohort 2
Subjects will be randomized to receive either placebo or 80 mg INV-101
Drug: INV-101
Subjects will be randomized to receive INV-101 tablets

Drug: Placebo
Subjects will be randomized to receive placebo tablets

Experimental: Cohort 3
Subjects will be randomized to receive either placebo or 160 mg INV-101
Drug: INV-101
Subjects will be randomized to receive INV-101 tablets

Drug: Placebo
Subjects will be randomized to receive placebo tablets

Experimental: Cohort 4
Subjects will be randomized to receive either placebo or 320 mg INV-101
Drug: INV-101
Subjects will be randomized to receive INV-101 tablets

Drug: Placebo
Subjects will be randomized to receive placebo tablets

Experimental: Cohort 5
Subjects will be randomized to receive either placebo or 500 mg INV-101
Drug: INV-101
Subjects will be randomized to receive INV-101 tablets

Drug: Placebo
Subjects will be randomized to receive placebo tablets




Primary Outcome Measures :
  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 Outcome Measures :
  1. Adverse events [ Time Frame: 72 hours ]
    Safety of INV-101 following single dose



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04531150


Locations
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Canada, Quebec
Altasciences
Montreal, Quebec, Canada
Sponsors and Collaborators
Inversago Pharma Inc.
Investigators
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Study Director: Glenn D Crater, MD Inversago Pharma
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Responsible Party: Inversago Pharma Inc.
ClinicalTrials.gov Identifier: NCT04531150    
Other Study ID Numbers: INV101-CL-101
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No