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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pharmacokinetic

Intervention / Treatment
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* Drug: INV-101
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Subjects will be randomized to receive either placebo or 20 mg INV-101 | Drug: INV-101<br>* Subjects will be randomized to receive INV-101 tablets<br>Drug: Placebo<br>* Subjects will be randomized to receive placebo tablets<br>|
| Experimental: Cohort 2<br>Subjects will be randomized to receive either placebo or 80 mg INV-101 | Drug: INV-101<br>* Subjects will be randomized to receive INV-101 tablets<br>Drug: Placebo<br>* Subjects will be randomized to receive placebo tablets<br>|
| Experimental: Cohort 3<br>Subjects will be randomized to receive either placebo or 160 mg INV-101 | Drug: INV-101<br>* Subjects will be randomized to receive INV-101 tablets<br>Drug: Placebo<br>* Subjects will be randomized to receive placebo tablets<br>|
| Experimental: Cohort 4<br>Subjects will be randomized to receive either placebo or 320 mg INV-101 | Drug: INV-101<br>* Subjects will be randomized to receive INV-101 tablets<br>Drug: Placebo<br>* Subjects will be randomized to receive placebo tablets<br>|
| Experimental: Cohort 5<br>Subjects will be randomized to receive either placebo or 500 mg INV-101 | Drug: INV-101<br>* Subjects will be randomized to receive INV-101 tablets<br>Drug: Placebo<br>* Subjects will be randomized to receive placebo tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters - Maximum Concentration (Cmax) | Cmax following single dose | 72 hours | 
| Pharmacokinetic parameters - AUC | AUC following single dose | 72 hours | 
| Pharmacokinetic parameters - Half-live | Half-live following single dose | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Safety of INV-101 following single dose | 72 hours |