Evaluation of Metabolic Profile of OC000459
An Evaluation of the Plasma and Urine Pharmacokinetics of Parent Compound and a Metabolite of OC000459 in Healthy Male and Female Subjects
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 asthma
Started Mar 2015
Shorter than P25 for phase_1 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2015
CompletedFirst Posted
Study publicly available on registry
January 19, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMay 25, 2015
March 1, 2015
2 months
January 14, 2015
May 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Metabolite
Metabolite AUC
Day 8
Secondary Outcomes (1)
Parent compound
Day 8
Study Arms (1)
OC000459 50 mg
EXPERIMENTALOC000459 50 mg daily for 8 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Atopix Therapeutics, Ltd.lead
- Simbec Researchcollaborator
Study Sites (1)
Simbec Research
Merthyr Tydfil, Wales, CF48 4DR, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Salvatore Febbraro, MD
Simbec Research
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2015
First Posted
January 19, 2015
Study Start
March 1, 2015
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
May 25, 2015
Record last verified: 2015-03