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Development of Minidose Inje Cocktail Method for Simultaneous Evaluating Five Cytochrome P450 Isoforms in Human

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jae-Gook Shin, Inje University
ClinicalTrials.gov Identifier:
NCT01570569
First received: December 6, 2011
Last updated: April 1, 2012
Last verified: April 2012
  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

Resource links provided by NLM:


Further study details as provided by Inje University:

Primary Outcome Measures:
  • 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:
  • The drug was made by Yuhan corp.
  • The drug was exclusively made for this study.
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:
  • All of the drugs were made by Yuhan corp.
  • All of the drugs were exclusively made for this study.
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:
  • The drug was made by Yuhan corp.
  • The drug was exclusively made for this study.
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:
  • All of the drugs were made by Yuhan corp.
  • All of the drugs were exclusively made for this study.
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:
  • The drug was made by Yuhan corp.
  • The drug was exclusively made for this study.
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:
  • All of the drugs were made by Yuhan corp.
  • All of the drugs were exclusively made for this study.
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:
  • All of the drugs were made by Yuhan corp.
  • All of the drugs were exclusively made for this study.
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:
  • The drug was made by Yuhan corp.
  • The drug was exclusively made for this study.
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:
  • All of the drugs were made by Yuhan corp.
  • All of the drugs were exclusively made for this study.
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:
  • The drug was made by Yuhan corp.
  • The drug was exclusively made for this study.

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
Criteria

Inclusion Criteria:

  • Healthy male subject whose CYP2C9, CYP2C19, CYP2D6 genotype was determined

Exclusion Criteria:

  • Subject who has abnormal laboratory test results
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570569

Sponsors and Collaborators
Inje University
Investigators
Principal Investigator: Jae Gook Shin, MD, PhD Inje University
  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
Losartan
Midazolam
Omeprazole
Adjuvants, Anesthesia
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anti-Anxiety Agents
Anti-Arrhythmia Agents
Anti-Ulcer Agents
Antihypertensive Agents
Antitussive Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Central Nervous System Stimulants
Enzyme Inhibitors
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
GABA Agents
GABA Modulators
Gastrointestinal Agents
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2014