Alfentanil: Simultaneous Testing Pilot

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: National Institute of General Medical Sciences (NIGMS)
• Treatments: Alfentanil; Ketoconazole; Rifampin

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