Development of Minidose Inje Cocktail Method for Simultaneous Evaluating Five Cytochrome P450 Isoforms in Human
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Omeprazole Drug: Losartan Drug: Dextromethorphan Drug: Cocktail Drug: Midazolam Drug: Caffeine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: 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 |
- Cmax, AUC [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post‐dose ] [ Designated as safety issue: Yes ]
| Enrollment: | 26 |
| Study Start Date: | January 2011 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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:
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 50 Years |
| Genders 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 More Information
No publications provided
| Responsible Party: | Jae-Gook Shin, Department of Pharmacology and Pharmacogenomics Research Center, Inje University |
| ClinicalTrials.gov Identifier: | NCT01570569 History of Changes |
| Other Study ID Numbers: | 10-152 |
| Study First Received: | December 6, 2011 |
| Last Updated: | April 1, 2012 |
| Health Authority: | South Korea: Institutional Review Board |
Keywords provided by Inje University:
|
Volunteers |
Additional relevant MeSH terms:
|
Caffeine Dextromethorphan Midazolam Omeprazole Losartan Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Purinergic P1 Receptor Antagonists Purinergic Antagonists |
Purinergic Agents Neurotransmitter Agents Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antitussive Agents Respiratory System Agents Adjuvants, Anesthesia Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on June 18, 2013