Pharmacokinetics of PN-235 in Healthy Volunteers

Study Overview
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Brief Summary
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This Phase 1 study is designed to determine the safety, tolerability and pharmacokinetics of PN-235 in healthy volunteers. The study will be conducted in three parts: Part 1 is a single ascending dose study, Part 2 is multiple ascending dose study, and Part 3 is a randomized, crossover solid dose comparison and effect of food study.

Detailed Description
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Part 1: Approximately 40 subjects randomized into 5 cohorts to receive PN-235 or placebo as single doses. Part 2: Approximately 50 subjects enrolled into 5 cohorts to receive PN-235 or placebo once daily for 10 days. Part 3: Twelve subjects will receive single doses of PN-235 in a 4-way, randomized, crossover fashion. In total, approximately 102 subjects will participate.

Official Title
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A Randomised, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of PN-235 in Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: PN-235
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Subjects must have BMI between 18 and 32 Subjects must be non-smokers or social smokers Subjects must comply with contraception requirements Subjects must be willing to consume meals provided by the clinical center Key Exclusion Criteria: Subject must not have history of clinically significant endocrine, neurological, cardiovascular, hematological, hepatic, immunological, renal, respiratory, gastrointestinal or genitourinary abnormalities or diseases within previous 10 years Subjects must not have history of surgical resection of the stomach, small or large intestine Subjects must not have fever or symptomatic viral or bacterial infection within 2 weeks of screening Subjects must not have corrected QT greater than 450 msec in males and 470 msec in females Subjects must not test positive for Hepatitis C or B at Screening Subjects must refrain from use of prescription and non-prescription drugs and herbal remedies prior to initial dose of study drug and throughout the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Dose<br>Single dose administration | Drug: PN-235<br>* Active Drug<br>* Other names: Active Drug;Drug: Placebo<br>* Matching Placebo<br>|
| Experimental: Multiple Dose<br>Multiple dose administration | Drug: PN-235<br>* Active Drug<br>* Other names: Active Drug;Drug: Placebo<br>* Matching Placebo<br>|
| Experimental: Solid Dose Comparison<br>Solid dose administartion | Drug: PN-235<br>* Active Drug<br>* Other names: Active Drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of PN-235 | Number and severity of Adverse Events | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) of PN-235 in plasma | Peak concentration (Cmax) of PN-235 | 10 days | 
| Area Under the Concentration (AUC) of PN-235 | AUC over 24 hours on Day 10 for PN-235 | 10 days |