N/A
N=6
Alfentanil: Simultaneous Testing Pilot
Evaluate Two Paradigms for Simultaneous Assessment of Hepatic and Intestinal CYP3A
Bottom Line
View on ClinicalTrials.gov: NCT01008059 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity — 58; 57; 55; 73 (hr*ng/ml/mg) — p=<.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Alfentanil (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity |
58; 57; 55; 73; 59; 54 | <.05 sig |
Summary
To evaluate two paradigms for simultaneous assessment of hepatic and intestinal CYP3A activity.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01008059). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.