Alfentanil: Simultaneous Testing Pilot
Novel Noninvasive Assessment of Cytochrome P4450 Activity: Simultaneous Testing Pilot
2 other identifiers
interventional
6
1 country
1
Brief Summary
To evaluate two paradigms for simultaneous assessment of hepatic and intestinal CYP3A activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 3, 2009
CompletedFirst Posted
Study publicly available on registry
November 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
May 17, 2019
CompletedMay 17, 2019
May 1, 2019
6.9 years
November 3, 2009
February 16, 2018
May 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity
AUC(0-inf)
9 hours
Study Arms (1)
Alfentanil
EXPERIMENTALAlfentanil (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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University/Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Evan D. Kharasch, MD PhD
- Organization
- Washington University
Study Officials
- PRINCIPAL INVESTIGATOR
Evan D Kharasch, MD, PhD
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2009
First Posted
November 5, 2009
Study Start
October 1, 2009
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
May 17, 2019
Results First Posted
May 17, 2019
Record last verified: 2019-05