Alfentanil: Simultaneous Testing Pilot

Not Applicable

Completed

• Conditions: Evaluate Two Paradigms for Simultaneous Assessment of Hepatic and Intestinal CYP3A
• Interventions: Drug: Alfentanil

• Registration Number: NCT01008059
• Lead Sponsor: Washington University School of Medicine

Brief Summary

To evaluate two paradigms for simultaneous assessment of hepatic and intestinal CYP3A activity.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-03
• Study First Submitted QC: 2009-11-03
• Study First Posted: 2009-11-05
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Results First Submitted: 2018-02-16
• Status Verified: 2019-05
• Results First Submitted QC: 2019-05-15
• Last Update Submitted: 2019-05-15
• Results First Posted: 2019-05-17
• Last Update Posted: 2019-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alfentanil	Alfentanil	Alfentanil (0.5-1 mg IV bolus) followed 3 hours later or simultaneously by 1-4 mg oral deuterium-labeled (d3) alfentanil on each study visit.

Primary Outcome Measures

Name	Time	Method
Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity	9 hours	AUC(0-inf)

Trial Locations

Locations (1)

Washington University/Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States