Evaluate Two Paradigms for Simultaneous Assessment of Hepatic and Intestinal CYP3ANCT01008059

Alfentanil: Simultaneous Testing Pilot

A study testing Alfentanil in people with Evaluate Two Paradigms for Simultaneous Assessment of Hepatic and Intestinal CYP3A, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate two paradigms for simultaneous assessment of hepatic and intestinal CYP3A activity. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Evaluate Two Paradigms for Simultaneous Assessment of Hepatic and Intestinal CYP3A
What is being tested?: Alfentanil
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Oct 2009to Sep 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University/Barnes Jewish Hospital
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Novel Noninvasive Assessment of Cytochrome P4450 Activity: Simultaneous Testing Pilot

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

Conditions: Evaluate Two Paradigms for Simultaneous Assessment of Hepatic and Intestinal CYP3A
Being tested: Alfentanil

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlfentanilDrug
No drug treatment before alfentanil

Study groups in NCT01008059
Study group	Role	What they receive
Alfentanil	Experimental	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. Receives: Drug: Alfentanil

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity
AUC(0-inf)
Measured: 9 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Sep 2016

First posted5 Nov 2009 (estimated)
Study startOct 2009
Primary completionSep 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Evaluate Two Paradigms for Simultaneous Assessment of Hepatic and Intestinal CYP3AStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01008059
Sponsor's protocol ID: 09-0715-201103523
Other IDs: 5R01GM063674-07
Status last verified: May 2019
First submitted: 3 Nov 2009
Last updated: 17 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Novel Noninvasive Assessment of Cytochrome P4450 Activity: Simultaneous Testing Pilot
ClinicalTrials.gov ID: NCT01008059
Acronym / sponsor ID: 09-0715-201103523
Conditions: Evaluate Two Paradigms for Simultaneous Assessment of Hepatic and Intestinal CYP3A
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: National Institute of General Medical Sciences (NIGMS)
Study start: Oct 2009 (actual)
Primary completion: Sep 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 5 Nov 2009 (estimated)
Results: Posted 17 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Alfentanil	Experimental	Drug: AlfentanilAlfentanil (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.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (10 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AlfentanilNo drug treatment before alfentanil	Drug	Alfentanil

Primary outcome

Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity
Time frame: 9 hours
AUC(0-inf)

Results and safety

Results posted to the registry on 17 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Sequential Alfentanil	6	6
Rifampin Sequential Alfentanil	0	0
Grapefruit Juice Sequential Alfentanil	0	0
Ketoconazole Sequential Alfentanil	0	0
Control Simultaneous Alfentanil	0	0
Rifampin Simultaneous Alfentanil	0	0
Grapefruit Juice Simultaneous Alfentanil	0	0
Ketoconazole Simultaneous Alfentanil	0	0

Primary outcome: Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity

Time frame: 9 hours. Mean (Standard Deviation). Unit: (hr*ng/ml/mg)

Measure	Alfentanil n = 6
Simultaneous Control	58 (15)
Simultaneous Rifampin	57 (9)
Simultaneous Grapefruit	55 (12)
Simultaneous ketoconazole	73 (26)
Sequential Control	59 (27)
Sequential Rifampin	54 (10)
Sequential Grapefruit	59 (31)
Sequential Ketoconazole	73 (19)

Alfentanil: p <.05, ANOVA

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Sequential Alfentanil	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Refampin Sequential Alfentanil	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Grapefruit Juice Sequential Alfentanil	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Ketoconazole Sequential Alfentanil	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Control Simultaneous Alfentanil	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Rifampin Simultaneous Alfentanil	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Grapefruit Juice Simultaneous Alfentanil	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Ketoconazole Simultaneous Alfentanil	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Evan D Kharasch, MD, PhD principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Curve of Alfentanil Concentration vs. Time Extrapolated to Infinity (time frame: 9 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01008059.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2019.