MedTrace Logo

Efavirenz and Ritonavir on Human Brain P-Glycoprotein

NCT01668147 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-01-22

Study results available
· View outcomes & findings →

Summary

To determine the effects of ritonavir and efavirenz on the activity of P-glycoprotein in human brain.

Conditions

  • Drug Effects

Interventions

DRUG

[11C] desmethyl-loperamide

IV administration of 10-14 mCi of \[11C\] desmethyl-loperamide with PET/CT imaging

OTHER

Control - no pretreatment

Session 1: IV administration of 10-14 mCi \[11C\] desmethyl-loperamide (dLop) with PET/CT imaging and brain MRI

DRUG

Oral ritonavir

Session 2: Pretreatment with oral ritonavir for 3 days followed by IV administration of 10-14 mCi \[11C\]dLop with PET/CT imaging and brain MRI

DRUG

Oral efavirenz

Session 3: Pretreatment with oral efavirenz for 14 days followed by IV administration of 10-14 mCi \[11C\]dLop with PET/CT imaging and brain MRI

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Evan Kharasch, MD, PhD. · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2016-06-30
Completion
2016-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01668147 on ClinicalTrials.gov