Development of Minidose Inje Cocktail Method for Simultaneous Evaluating Five Cytochrome P450 Isoforms in Human
Sponsor
Inje University (Other)
Overall Status
Completed
CT.gov ID
NCT01570569
Collaborator
(none)
26
5
1.9
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
The investigators objectives were developing minidose 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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Development of High-throughput Minidose Inje Cocktail Method for Simultaneous Evaluating Five Cytochrome P450 Isoforms in Human
Study Start Date
:
Jan 1, 2011
Actual Primary Completion Date
:
Mar 1, 2011
Actual Study Completion Date
:
Mar 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Omeprazole
|
Drug: Omeprazole
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.
Other Names:
Drug: Cocktail
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.
Other Names:
|
| Active Comparator: Losartan
|
Drug: Losartan
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.
Other Names:
Drug: Cocktail
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.
Other Names:
|
| Active Comparator: Dextromethorphan
|
Drug: Dextromethorphan
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.
Other Names:
Drug: Cocktail
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.
Other Names:
|
| Active Comparator: Caffeine
|
Drug: Cocktail
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.
Other Names:
Drug: Caffeine
Thirteen healthy male subjects received 100 μg midazolam and 2 mg caffeine individually followed by five-drugs cocktail every two days.
Other Names:
|
| Active Comparator: Midazolam
|
Drug: Cocktail
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.
Other Names:
Drug: Midazolam
Thirteen healthy male subjects received 100 μg midazolam and 2 mg caffeine individually followed by five-drugs cocktail every two days.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Cmax, AUC [0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose]
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Healthy male subject whose CYP2C9, CYP2C19, CYP2D6 genotype was determined
Exclusion Criteria:
- Subject who has abnormal laboratory test results
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Inje University
Investigators
- Principal Investigator: Jae Gook Shin, MD, PhD, Inje University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Jae-Gook Shin,
Department of Pharmacology and Pharmacogenomics Research Center,
Inje University
ClinicalTrials.gov Identifier:
NCT01570569
Other Study ID Numbers:
- 10-152
First Posted:
Apr 4, 2012
Last Update Posted:
Apr 4, 2012
Last Verified:
Apr 1, 2012
Keywords provided by Jae-Gook Shin,
Department of Pharmacology and Pharmacogenomics Research Center,
Inje University
Additional relevant MeSH terms: