Alfentanil: Simultaneous Testing Pilot
Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: To Evaluate Two Paradigms for Simultaneous Assessment of Hepatic and Intestinal CYP3A Activity
Intervention: of d0- and d3-alfentanil (Drug)
Phase: N/A
Status: Completed
Sponsored by: Washington University School of Medicine Official(s) and/or principal investigator(s): Evan D Kharasch, MD, PhD, Principal Investigator, Affiliation: Washington University School of Medicine
Summary
To evaluate two paradigms for simultaneous assessment of hepatic and intestinal CYP3A
activity.
Clinical Details
Official title: Novel Noninvasive Assessment of Cytochrome P4450 Activity: Simultaneous Testing Pilot
Study design: Time Perspective: Prospective
Primary outcome: Primary outcome is the area under the curve of alfentanil concentration vs. time.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Washington University/Barnes Jewish Hospital, St. Louis, Missouri 63110, United States
Additional Information
Starting date: October 2009
Last updated: January 21, 2015
|