Pharmacokinetics of PN-235 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-12

Study Completion Date

2021-10-13

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.

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Part 1 blinded, Part 2 blinded, Part 3 unblinded

Study Groups

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Single Dose

Single dose administration

Group Type EXPERIMENTAL

PN-235

Intervention Type DRUG

Active Drug

Placebo

Intervention Type DRUG

Matching Placebo

Multiple Dose

Multiple dose administration

Group Type EXPERIMENTAL

PN-235

Intervention Type DRUG

Active Drug

Placebo

Intervention Type DRUG

Matching Placebo

Solid Dose Comparison

Solid dose administartion

Group Type EXPERIMENTAL

PN-235

Intervention Type DRUG

Active Drug

Interventions

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PN-235

Active Drug

Intervention Type DRUG

Placebo

Matching Placebo

Intervention Type DRUG

Other Intervention Names

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Active Drug

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes