Evaluation of Metabolic Profile of OC000459 | NCT02341521

Studies
Evaluation of Metabolic Profile of OC000459

NCT02341521

Sponsor

Atopix Therapeutics, Ltd.

Status

Completed

Last Update Posted

May 25, 2015Estimated

Enrollment

18Actual

Phase

Phase 1

Conditions

Asthma

Interventions

OC000459

Countries

United Kingdom

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

Mar 2015

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

Mar 2015

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Jan 14, 2015

First Submission Date that Met QC Criteria

Jan 16, 2015

First Posted Date

Jan 19, 2015Estimated

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

May 22, 2015

Last Update Posted Date

May 25, 2015Estimated

Name	Class
Simbec Research	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 study in 9 male and 9 female healthy subjects to determine the pharmacokinetics of parent compound and metabolite after eight days of dosing.

Detailed Description

The study will include 9 male and 9 female healthy subjects. Following informed consent and satisfactory screening, each will be dosed for seven consecutive days on an outpatient basis with OC000459 50 mg daily taken before breakfast. On the seventh day, subjects will report to the clinical unit. Following an overnight fast, blood samples will be drawn for baseline safety and pharmacokinetic measurements and a urine specimen will be obtained for urinalysis and baseline metabolite measurements and subjects will be dosed with 50 mg OC000459. Blood samples will then be drawn at selected intervals for 120 hours post dosing and will be analysed for OC000459 parent compound and its metabolite. Urine collections will be obtained over the same period to determine the excretion of the metabolite and parent compound in urine.

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

18Actual

Label	Type	Description	Intervention Names
OC000459 50 mg	Experimental	OC000459 50 mg daily for 8 days	Drug: OC000459

Name	Type	Description	Arm Group Labels	Other Names
OC000459	Drug	Taken orally for 8 days	OC000459 50 mg

Measure	Description	Time Frame
Metabolite	Metabolite AUC	Day 8

Measure	Description	Time Frame
Parent compound	Parent compound AUC	Day 8

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male and female subjects, any racial group
Aged 18-55 years inclusive
Able to comply with the protocol
Subjects with a Body Mass Index (BMI) of 21-28 (BMI = Body weight (kg) / (Height (m)2)
Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 21 days of the first dose

Exclusion Criteria:

A history of gastrointestinal disorder likely to influence drug absorption
Receipt of any medication including over the counter preparations and vitamins within 14 days of the first study day with the exception of paracetamol up to a maximum of 2 g daily
Evidence of clinically significant renal, hepatic, cardiovascular or metabolic dysfunction
A history of drug or alcohol abuse
Inability to communicate well with the investigator (i.e., language problem, poor mental development or impaired cerebral function)
Participation in a clinical study within 3 months of the first dose of study drug. Subjects will be checked against The Over Volunteering Prevention System (TOPS)
Donation of 450 mL or more blood within 60 days of the first dose of study drug
A history of hypersensitivity and/or idiosyncrasy to any of the test compounds or related drugs or excipients employed in this study
Pregnancy or lactation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases