Evaluation of Metabolic Profile of OC000459

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Atopix Therapeutics, Ltd.
• Collaborator: Simbec Research
• Treatments: Indoleacetic Acids

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