Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of PAT-1251 in Healthy Adult Subjects

Study Overview
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Brief Summary
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A single-center, randomized, placebo-controlled study consisting of both a single ascending dose (SAD) and a multiple ascending dose (MAD) portion to evaluate the safety, tolerability, pharmacokinetics and effect of food using PAT-1251 orally administered to healthy subjects

Official Title
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A Phase 1, Randomised, Placebo-Controlled, Ascending Single and Multiple Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of PAT-1251 in Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PAT-1251
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive body weight of 50 to 100 kg, inclusive subjects must be in good health Exclusion Criteria: male subjects who do not agree, or whose partners of childbearing potential do not agree, to use appropriate contraception female subjects of childbearing potential who do not agree to use 2 acceptable methods of contraception history of, any clinically significant major disorder clinically significant allergic condition significant history of alcoholism or drug/chemical abuse use of any tobacco or nicotine-containing products clinically significant abnormality in heart rate, blood pressure, temperature, respiration rate, electrocardiogram or clinical laboratory findings positive urine drugs of abuse screen or alcohol breath test

Ages Eligible for Study
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Minimum Age: 18 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAT-1251 Single Dose<br>Oral solution of PAT-1251, 150 - 4000 mg administered once | Drug: PAT-1251<br> <br> |
| Placebo Comparator: Placebo Single Dose<br>Matching placebo solution administered once | Drug: Placebo<br> <br> |
| Experimental: PAT-1251 Multiple Dose<br>Oral tablet(s) of PAT-1251 up to 2000 mg administered daily for 7 days | Drug: PAT-1251<br> <br> |
| Experimental: Placebo Multiple Dose<br>Matching placebo tablets administered daily for 7 days | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | Determination of adverse events will include assessment of vital signs, ECG, clinical laboratory and physical examination | one to seven days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) |  | one to seven days | 
| Area Under the Plasma Concentration Versus Time Curve (AUC) |  | one to seven days | 
| Time to Maximum Observed Plasma Concentration (Tmax) | Comparative pharmacokinetics of single dose administered in a fasted state and following a meal | one to seven days | 
| Terminal elimination half-life (t½) |  | one to seven days |