Study to Evaluate the Potential for Interaction Between OC000459 and CYP 450 3A4

Healthy Volunteers Clinical Trial

Official title:

An Open Label Balanced Study in Healthy Subjects to Evaluate the Potential for Cytochrome P 450 3A4 Induction by Oral OC000459 Using Oral Midazolam as a Probe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056575
• Other study ID #: OC000459/014/09
• Status: Completed
• Phase: Phase 1
• First received: January 25, 2010
• Last updated: September 1, 2010
• Start date: February 2010
• Est. completion date: May 2010

Study information

• Verified date: September 2010
• Source: Oxagen Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This will be an open label, sequential study of midazolam (dose 5 mg orally) followed by midazolam (5 mg orally) given after dosing with OC000459 100 mg twice daily for 6.5 days. Twenty subjects will be included to ensure at least 16 subjects with analysable PK data. PK sampling for midazolam and 4-hydroxymidazolam plasma concentrations will continue for up to and including 24 hours after dosing with midazolam on both occasions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Judged to be in good health at screening (blood tests, physical examination, medical history)

Exclusion Criteria:

• Evidence of a clinically significant underlying medical condition that in the opinion of the Investigator would represent a risk to study participation.

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• OC000459
OC000459 100mg tablet, twice daily

Locations

Country	Name	City	State
United Kingdom	Simbec Research Ltd	Merthyr Tydfil

Sponsors (1)

Lead Sponsor	Collaborator
Oxagen Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of exposure of midazolam and 4-hydroxymidazolam (without/with exposure to OC000459) as measured by plasma AUC0-t and Cmax for midazolam and its active metabolite 4-hydroxymidazolam.		6.5 days	No
Secondary	Additional PK parameters of midazolam and its active metabolite 4-hydroxymidazolam		6.5 days	No
Secondary	Safety and tolerability of OC000459		6.5 days	Yes