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

Oxagen Ltd20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

OC000459DRUG

OC000459 100mg tablet, twice daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Simbec Research Ltd

Merthyr Tydfil, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: 6.5 days

Secondary Outcomes

Additional PK parameters of midazolam and its active metabolite 4-hydroxymidazolam

Time frame: 6.5 days

Safety and tolerability of OC000459

Time frame: 6.5 days

Data from ClinicalTrials.gov

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