Drug EffectsPhase 1/2NCT01668147
Efavirenz and Ritonavir on Human Brain P-Glycoprotein
A Phase 1/2 study testing [11C] desmethyl-loperamide, Oral ritonavir and Oral efavirenz in people with Drug Effects, run by Washington University School of Medicine at 1 site in United States.
Trial summary
To determine the effects of ritonavir and efavirenz on the activity of P-glycoprotein in human brain. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Effects
- What is being tested?
- [11C] desmethyl-loperamide, Oral ritonavir and Oral efavirenz
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2016
- Phase
- Phase 1/2
- 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
- BMI < 33
- Provide informed consent
Who cannot join
- Known history of liver or kidney disease
- History of major medical conditions
- HIV seropositive
- Fasting blood glucose > 110 mg/dl
- Family history of type 2 diabetes
- Use of prescription or non prescription medications, herbals or foods known to be metabolized by or altering P-glycoprotein or CYP3A activity (hormonal birth control medications are acceptable if alternative means of contraception are used)
Show all 10Show fewer
- Females who are pregnant or nursing
- Females taking hormonal contraceptives who are unwilling to use alternative means of contraception
- Contraindications to MRI
- Contraindications to PET scanning
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Influence of Efavirenz and Ritonavir on Human Brain P-Glycoprotein Activity Using PET Imaging
To determine the effects of ritonavir and efavirenz on the activity of P-glycoprotein in human brain.
Read the detailed description
Sequential crossover using tracer 11C-desmethylloperamide, a substrate for brain P-glycoprotein, and positron emission tomography (PET), administered after nothing (control), oral ritonavir (3d), and oral efavirenz (14d) with washout in between
- Conditions
- Drug Effects
- Being tested
- [11C] desmethyl-loperamide, Control - no pretreatment, Oral ritonavir, Oral efavirenz
- Keywords
- PET Imaging, Efavirenz, Ritonavir, [11C] desmethyl-loperamide, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C] desmethyl-loperamideDrug
IV administration of 10-14 mCi of [11C] desmethyl-loperamide with PET/CT imaging
Control - no pretreatmentOther
Session 1: IV administration of 10-14 mCi [11C] desmethyl-loperamide (dLop) with PET/CT imaging and brain MRI
Oral ritonavirDrug
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
Oral efavirenzDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Session 1: Control (no pretreatment) - IV 10-14 mCi of [11C] desmethyl-loperamide (dLop) with PET/CT imaging Receives: Drug: [11C] desmethyl-loperamide; Other: Control - no pretreatment |
| Oral ritonavir | Active comparator | Session 2: Pretreatment with oral ritonavir for 3 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging Receives: Drug: [11C] desmethyl-loperamide; Drug: Oral ritonavir |
| Oral efavirenz | Active comparator | Session 3: Pretreatment with oral efavirenz for 14 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging Receives: Drug: [11C] desmethyl-loperamide; Drug: Oral efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral [11C]dLop Distribution Volume
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2016
- Study completionAug 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 Drug EffectsStudies 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 1/2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evan Kharasch, MD, PhD., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668147
- Sponsor's protocol ID
- 201205135
- Status last verified
- Jan 2020
- First submitted
- 30 Jul 2012
- Last updated
- 22 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Efavirenz and Ritonavir on Human Brain P-Glycoprotein Activity Using PET Imaging
- ClinicalTrials.gov ID
- NCT01668147
- Acronym / sponsor ID
- 201205135
- Conditions
- Drug Effects
- Keywords
- PET Imaging, Efavirenz, Ritonavir, [11C] desmethyl-loperamide, Healthy volunteers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 17 Aug 2012 (estimated)
- Results
- Posted 22 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effects of ritonavir and efavirenz on the activity of P-glycoprotein in human brain.
Detailed description
Sequential crossover using tracer 11C-desmethylloperamide, a substrate for brain P-glycoprotein, and positron emission tomography (PET), administered after nothing (control), oral ritonavir (3d), and oral efavirenz (14d) with washout in between
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Drug: [11C] desmethyl-loperamide, Other: Control - no pretreatmentSession 1: Control (no pretreatment) - IV 10-14 mCi of [11C] desmethyl-loperamide (dLop) with PET/CT imaging |
| Oral ritonavir | Active comparator | Drug: [11C] desmethyl-loperamide, Drug: Oral ritonavirSession 2: Pretreatment with oral ritonavir for 3 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging |
| Oral efavirenz | Active comparator | Drug: [11C] desmethyl-loperamide, Drug: Oral efavirenzSession 3: Pretreatment with oral efavirenz for 14 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging |
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
- BMI < 33
- Provide informed consent
Key exclusion criteria (10 listed)
- Known history of liver or kidney disease
- History of major medical conditions
- HIV seropositive
- Fasting blood glucose > 110 mg/dl
- Family history of type 2 diabetes
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 |
|---|---|---|
| [11C] desmethyl-loperamideIV administration of 10-14 mCi of [11C] desmethyl-loperamide with PET/CT imaging | Drug | Control, Oral efavirenz, Oral ritonavir |
| Control - no pretreatmentSession 1: IV administration of 10-14 mCi [11C] desmethyl-loperamide (dLop) with PET/CT imaging and brain MRI | Other | Control |
| Oral ritonavirSession 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 ritonavir |
| Oral efavirenzSession 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 | Drug | Oral efavirenz |
Primary outcome
Cerebral [11C]dLop Distribution Volume
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 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?
A Phase 1/2 study testing [11C] desmethyl-loperamide, Oral ritonavir and Oral efavirenz in people with Drug Effects, run by Washington University School of Medicine at 1 site in United States.
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 22 Jan 2020. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2020). 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?
Cerebral [11C]dLop Distribution Volume (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2020.