Alfentanil: Simultaneous Testing Pilot
This trial is active, not recruiting.
|Condition||to evaluate two paradigms for simultaneous assessment of hepatic and intestinal cyp3a activity|
|Treatments||grapefruit juice, delayed alfentanil, concomitant alfentanil|
|Sponsor||Washington University School of Medicine|
|Start date||October 2009|
|End date||September 2016|
|Trial size||40 participants|
|Trial identifier||NCT01008059, 09-0715, 5 RO1 GM063674-07|
To evaluate two paradigms for simultaneous assessment of hepatic and intestinal CYP3A activity.
|Endpoint classification||pharmacodynamics study|
|Intervention model||crossover assignment|
|Masking||single blind (subject)|
|Primary purpose||basic science|
Primary outcome is the area under the curve of alfentanil concentration vs. time.
time frame: 12 hours
Male or female participants from 18 years up to 40 years old.
- Male or non-pregnant female, 18-40 yr. old
- Good general health with no remarkable medical conditions such as liver, kidney, heart, or lung failure
- BMI between 20-33
- Provide informed consent
- Known history of liver or kidney disease
- Use of prescription or non prescription medications, herbals or foods known to be metabolized by or affect CYP3A (including oral birth control medications)
- Females who are pregnant or nursing
- Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)
- Direct physical access to and routine handling of addicting drugs in the regular course of duty (this is a routine exclusion from studies of drugs with addiction potential).
- History of bradycardia
- Respiratory rate <10
- History of significant pulmonary disease
- History of pre-existing medical condition predisposing to respiratory depression
- Systolic blood pressure <100 mgHg and diastolic blood pressure <70mmHg
|Official title||Novel Noninvasive Assessment of Cytochrome P4450 Activity: Simultaneous Testing Pilot|
|Principal investigator||Evan D Kharasch, MD, PhD|
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