Alfentanil: Simultaneous Testing Pilot

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2016-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Evaluate Two Paradigms for Simultaneous Assessment of Hepatic and Intestinal CYP3A

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Alfentanil

Intervention Type DRUG

No drug treatment before alfentanil

Interventions

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Alfentanil

No drug treatment before alfentanil

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes