Evaluation of Metabolic Profile of OC000459

Asthma Clinical Trial

Official title:

An Evaluation of the Plasma and Urine Pharmacokinetics of Parent Compound and a Metabolite of OC000459 in Healthy Male and Female Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02341521
• Other study ID #: OC000459/018/14
• Status: Completed
• Phase: Phase 1
• First received: January 14, 2015
• Last updated: May 22, 2015
• Start date: March 2015
• Est. completion date: May 2015

Study information

• Verified date: March 2015
• Source: Atopix Therapeutics, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• OC000459
Taken orally for 8 days

Locations

Country	Name	City	State
United Kingdom	Simbec Research	Merthyr Tydfil	Wales

Sponsors (2)

Lead Sponsor	Collaborator
Atopix Therapeutics, Ltd.	Simbec Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolite	Metabolite AUC	Day 8	No
Secondary	Parent compound	Parent compound AUC	Day 8	No