Evaluation of Metabolic Profile of OC000459

NCT ID: NCT02341521

Last Updated: 2015-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-05-31

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.

Conditions

Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

OC000459 50 mg

OC000459 50 mg daily for 8 days

Group Type: EXPERIMENTAL

OC000459

Intervention Type: DRUG

Taken orally for 8 days

Interventions

OC000459

Taken orally for 8 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy male and female subjects, any racial group

2. Aged 18-55 years inclusive

3. Able to comply with the protocol

4. Subjects with a Body Mass Index (BMI) of 21-28 (BMI = Body weight (kg) / (Height (m)2)

5. Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 21 days of the first dose

Exclusion Criteria

1. A history of gastrointestinal disorder likely to influence drug absorption

2. 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

3. Evidence of clinically significant renal, hepatic, cardiovascular or metabolic dysfunction

4. A history of drug or alcohol abuse

5. Inability to communicate well with the investigator (i.e., language problem, poor mental development or impaired cerebral function)

6. 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)

7. Donation of 450 mL or more blood within 60 days of the first dose of study drug

8. A history of hypersensitivity and/or idiosyncrasy to any of the test compounds or related drugs or excipients employed in this study

9. Pregnancy or lactation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Simbec Research

INDUSTRY

Sponsor Role: collaborator

Atopix Therapeutics, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Salvatore Febbraro, MD

Role: PRINCIPAL_INVESTIGATOR

Simbec Research

Locations

Simbec Research

Merthyr Tydfil, Wales, United Kingdom

Countries

United Kingdom

Other Identifiers

OC000459/018/14

Identifier Type: -

Identifier Source: org_study_id