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Clinical Trials/NCT01935830
NCT01935830CompletedEarly Phase 1

Efavirenz and Ritonavir Influence on Human Brain Levo-acetylmethadol (LAAM) Disposition Assessed Using PET Imaging

Washington University School of Medicine1 site in 1 country10 target enrollmentStarted: August 2013Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Early Phase 1
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
cerebral [11C]LAAM distribution volume
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to determine the effects of the antiretroviral drugs efavirenz and ritonavir on human brain LAAM disposition in vivo.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

LAAM arm

Experimental
  1. [11C]LAAM 15-20 mCi (maximum administered mass of 10 ug)
  2. Efavirenz, oral capsules, 600 mg
  3. Ritonavir, oral capsules, 100 mg

Intervention: [11c] LAAM (Radiation)

LAAM arm

Experimental
  1. [11C]LAAM 15-20 mCi (maximum administered mass of 10 ug)
  2. Efavirenz, oral capsules, 600 mg
  3. Ritonavir, oral capsules, 100 mg

Intervention: Ritonavir (Drug)

LAAM arm

Experimental
  1. [11C]LAAM 15-20 mCi (maximum administered mass of 10 ug)
  2. Efavirenz, oral capsules, 600 mg
  3. Ritonavir, oral capsules, 100 mg

Intervention: Efavirenz (Drug)

Outcomes

Primary Outcomes

cerebral [11C]LAAM distribution volume

Time Frame: approximately 3 months

Blood tests, MRI and PET data analysis and interpretation

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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