PK/PD, Safety and Tolerability of PHP-201 Topical Eye Dro... | NCT03586908

Studies
PK/PD, Safety and Tolerability of PHP-201 Topical Eye Drop in Korean and Japanese Healthy Subjects

NCT03586908

Sponsor

pH Pharma

Status

Completed

Last Update Posted

Jul 16, 2018Actual

Enrollment

24Actual

Phase

Phase 1

Conditions

Healthy Volunteer

Interventions

PHP-201 0.5% ophthalmic solution (topical eye drop)

Countries

South Korea

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

Jul 2018

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

Feb 4, 2018Actual

Primary Completion Date

Feb 27, 2018Actual

Completion Date

Mar 9, 2018Actual

First Submitted Date

Apr 19, 2018

First Submission Date that Met QC Criteria

Jul 12, 2018

First Posted Date

Jul 16, 2018Actual

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

Jul 12, 2018

Last Update Posted Date

Jul 16, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

An open label, multiple-dose, phase 1 clinical trial to evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of PHP-201 topical eye drop in Korean and Japanese healthy subjects

Detailed Description

Primary: The evaluation of pharmacokinetic properties of repeating PHP-201 topical eye drop Secondary: The evaluation of pharmacodynamic, safety and tolerability of repeating PHP-201 topical eye drop

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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PHP-201 0.5%	Experimental	PHP-201 0.5%, ophthalmic solution, topical eye drop, OU	Drug: PHP-201 0.5% ophthalmic solution (topical eye drop)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PHP-201 0.5% ophthalmic solution (topical eye drop)	Drug	D1, D7: PHP-201 0.5% topical eye drop OU QD(AM), D2~D6: PHP-201 0.5% topical eye drop OU TID	PHP-201 0.5%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Plasma Concentration [Cmax]	Cmax of PHP-201 & Metabolite	1week
Time to Cmax[Tmax]	Tmax of PHP-201 & Metabolite	1week

Secondary Outcomes

Measure	Description	Time Frame
Mean Change of Intraocular pressure(IOP)	Mean Change from baseline IOP after 1week	1week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fully informed about the purpose of the study
BMI of 18.0 kg/m² or more and 27.0 kg/m² or less who are between 19 and 50 years of age
No congenital or chronic disease and no medically symptomatic findings

Exclusion Criteria:

Clinically significant disease history or disease history that may affect the absorption, distribution, metabolism and excretion of the drug, or ophthalmic corneal surgery
had BCVA worse than logMAR 0.2(20/30snellen) or IOP < 10mmHg or >21mmHg in either eye
Abnormalities of clinical examination (SBP, DBP, pulse rate, AST, ALT, Total bilirubin, eGFR and Serum test, ECG)
Allergy, drug hypersensitivity and substance abuse
Forbidden drug and diet
Blood donation and transfusion

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Soojin Kim	pH Pharma	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inje University Busan Baek Hospital		Busan	Busanjin-gu	47323	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000723048	sovesudil
D009883	Ophthalmic Solutions

Ancestor Terms

ID	Term
D019999	Pharmaceutical Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D045506	Therapeutic Uses

Browse Leaves

Not provided

Browse Branches

Not provided