Washington University/Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Completed
NCT Number: NCT01008059
Alfentanil: Simultaneous Testing Pilot
To evaluate two paradigms for simultaneous assessment of hepatic and intestinal CYP3A activity.
Completed
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Notify MeKey information
Age range
18 year–40 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
alfentanil
DrugNo drug treatment before alfentanil
Primary outcomes
-
Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity
Time frame: 9 hours
AUC(0-inf)
Sponsors and collaborators
Lead sponsor
Washington University School of Medicine
Other
Collaborators
- National Institute of General Medical Sciences (NIGMS)
Registry information
Official study title
Novel Noninvasive Assessment of Cytochrome P4450 Activity: Simultaneous Testing Pilot
Important dates
- Study start
- 2009
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Nov 5, 2009
- Registry last updated
- May 17, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.