Status:
COMPLETED
Effects of PQ912 on the Pharmacokinetics of Midazolam and Omeprazole
Lead Sponsor:
Vivoryon Therapeutics N.V.
Collaborating Sponsors:
Covance
Conditions:
Healthy Volunteers
Pharmacologic Action
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
Midazolam is a rapid-acting benzodiazepine, with a short half-life (approximately 1.9 hours) and is primarily metabolised by CYP3A. Omeprazole is a selective proton pump inhibitor substrate used to r...
Detailed Description
This will be an open-label, crossover, fixed sequence study in healthy male subjects. Thirty six (36) subjects will participate in the study and will be enrolled as two groups of 18 (Groups 1 and 2). ...
Eligibility Criteria
Inclusion
- males
- of any ethnic origin
- between 18 and 55 years of age
- body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive
- body weight between 50 kg and 100 kg inclusive
- must be in good health,
- will have given written informed consent and to abide by the study restrictions
Exclusion
- history of any clinically significant disease or disorder which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, may influence the results, or may limit the subject's ability to participate in the study
- history or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- active participation in a clinical study or participation in a clinical study investigating a new chemical entity within 3 months or 5 half-lives (whichever is longer prior to first dose)
- clinically significant illness within 4 weeks of the start of the dose administration
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02190708
Start Date
June 1 2014
End Date
August 1 2014
Last Update
October 21 2015
Active Locations (1)
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1
Covance Clinical Research Unit Ltd
Leeds, United Kingdom, LS2 9LH