Alfentanil: Simultaneous Testing Pilot

The Washington University

Status: Completed

Conditions: Evaluate Two Paradigms for Simultaneous Assessment of Hepatic and Intestinal CYP3A

Treatments: Drug: Alfentanil

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01008059

09-0715-201103523

5R01GM063674-07 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Alfentanil

Experimental group

Description:

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.

Treatment:

Drug: Alfentanil