Status:
COMPLETED
A Study of RO5186582 Treatment on Cytochrome P450 (CYP) 3A4 Activity in Healthy Participants
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This is a non-randomized, open-label, five treatment, fixed sequence cross-over study to investigate the effect of RO5186582 treatment on CYP3A activity using midazolam as a probe CYP3A substrate, and...
Eligibility Criteria
Inclusion
- Healthy participants with signed informed consent.
Exclusion
- A history of epilepsy, convulsions or significant head injury
- Significant history of drug allergy, as determined by the Investigator, or a known hypersensitivity to any of the ingredients of any of the study treatments
- Use of any drugs or substances, including herbal treatments such as St John's Wort, that are known to be substrates, inducers or inhibitors of CYP3A4 within 30 days of the first dose administration
- Pregnant or lactating
- Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02254759
Start Date
October 1 2014
End Date
November 1 2014
Last Update
November 2 2016
Active Locations (1)
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1
Leeds, United Kingdom, LS2 9LH