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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

Page last updated: August 20, 2015

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