Pharmacokinetics of PN-232 in Healthy Volunteers | NCT04819620

Studies
Pharmacokinetics of PN-232 in Healthy Volunteers

NCT04819620

Sponsor

Protagonist Therapeutics, Inc.

Status

Completed

Last Update Posted

Oct 3, 2022Actual

Enrollment

48Actual

Phase

Phase 1

Conditions

Healthy Subjects

Interventions

PN-232
Placebo

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 13, 2021Actual

Primary Completion Date

Dec 17, 2021Actual

Completion Date

Jun 16, 2022Actual

First Submitted Date

Mar 24, 2021

First Submission Date that Met QC Criteria

Mar 24, 2021

First Posted Date

Mar 29, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2022

Last Update Posted Date

Oct 3, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This Phase 1 study is designed to determine the safety, tolerability and pharmacokinetics of PN-232 in healthy volunteers. It is a first-in-human (FIH) study for PN-232 that 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 crossover solid dose comparison and effect of food study.

Detailed Description

Part 1: Approximately 32 subjects will be enrolled into 4 cohorts to receive PN-232 or placebo as single doses.

Part 2: Up to 40 subjects will be enrolled into 4 cohorts to receive PN-232 or placebo once daily for 10 days.

Part 3: Twelve subjects will receive single doses of PN-232 in a 3-way, randomized, crossover fashion.

In total, approximately 84 subjects will participate.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Dose	Experimental	Single dose administration	Drug: PN-232 Drug: Placebo
Multiple Dose	Experimental	Multiple dose administration	Drug: PN-232 Drug: Placebo
Solid Dose Comparison	Experimental	Solid dose administration	Drug: PN-232

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PN-232	Drug	Active Drug	Multiple Dose Single Dose Solid Dose Comparison

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of PN-232	Number and Severity of Adverse Events	10 days

Secondary Outcomes

Measure	Description	Time Frame
Peak concentration of PN-232 in plasma	Peak concentration (Cmax) of PN-232	10 days
Area under the Concentration (AUC) of PN-232	AUC over 24 hours on Day 10 for PN-232

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Subjects must have BMI between 18 and 32 kg/m2
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
Subjects must be willing to attend required clinic visits
Subjects must be suitable candidates for study procedures

Key Exclusion Criteria:

Subject with a history of clinically significant endocrine, neurological, cardiovascular, hematological, hepatic, immunological, renal, respiratory, gastrointestinal or genitourinary abnormalities or diseases within previous 10 years
Subjects with a history of surgical resection of the stomach, small or large intestine
Subjects with a fever or symptomatic viral or bacterial infection within 2 weeks of screening or intestinal infection within 30 days prior to screening
Subjects with clinically significant laboratory abnormalities
Subjects with corrected QT greater than 450 msec in males and 470 msec in females
Subjects who test positive for Hepatitis C or B, or HIV at Screening
Subjects who cannot refrain from use of prescription and non-prescription drugs and herbal remedies prior to initial dose of study drug and throughout the study
Subjects who test positive for drugs of abuse or alcohol at Screening

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Protagonist Clinical Site		Adelaide	South Australia	5000	Australia
Protagonist Study Site