Development of Minidose Inje Cocktail Method for Simultaneous Evaluating Five Cytochrome P450 Isoforms in Human
Development of High-throughput Minidose Inje Cocktail Method for Simultaneous Evaluating Five Cytochrome P450 Isoforms in Human
1 other identifier
interventional
26
0 countries
N/A
Brief Summary
The investigators objectives were developing mini dose five-drug cocktail regimen to evaluate potential drug-drug interactions associated with use of a cocktail of caffeine, losartan, omeprazole, dextromethorphan, and midazolam for simultaneous assessment of CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A activities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Jan 2011
Shorter than P25 for phase_1 healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 6, 2011
CompletedFirst Posted
Study publicly available on registry
April 4, 2012
CompletedApril 4, 2012
April 1, 2012
2 months
December 6, 2011
April 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cmax, AUC
0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose
Study Arms (5)
Omeprazole
ACTIVE COMPARATORLosartan
ACTIVE COMPARATORDextromethorphan
ACTIVE COMPARATORCaffeine
ACTIVE COMPARATORMidazolam
ACTIVE COMPARATORInterventions
Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days.
Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days.
Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days.
Group A : Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days. Group B : Thirteen healthy male subjects received 100 μg midazolam and 2 mg caffeine individually followed by five-drugs cocktail every two days.
Thirteen healthy male subjects received 100 μg midazolam and 2 mg caffeine individually followed by five-drugs cocktail every two days.
Thirteen healthy male subjects received 100 μg midazolam and 2 mg caffeine individually followed by five-drugs cocktail every two days.
Eligibility Criteria
You may qualify if:
- Healthy male subject whose CYP2C9, CYP2C19, CYP2D6 genotype was determined
You may not qualify if:
- Subject who has abnormal laboratory test results
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inje Universitylead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jae Gook Shin, MD, PhD
Inje University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Pharmacology and Pharmacogenomics Research Center
Study Record Dates
First Submitted
December 6, 2011
First Posted
April 4, 2012
Study Start
January 1, 2011
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
April 4, 2012
Record last verified: 2012-04