HealthyPhase 1NCT02001389
Study of EVP-6308 to Assess the Dose- and Concentration-dependent Displacement of [18F]MNI-659 by EVP-6308
A Phase 1 study testing EVP-6308 in people with Healthy, run by FORUM Pharmaceuticals Inc at 1 site in United States.
Trial summary
This is an open-label, single-arm, multiple ascending dose Phase I study to assess the dose- and concentration-dependent displacement of [18F]MNI-659 [a PET tracer targeting phosphodiesterase 10 (PDE10)] by EVP-6308. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- EVP-6308
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jun 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female volunteers, 18 to 50 years of age
Who cannot join
- Clinically significant abnormalities on physical examination, medical history, ECG , vital signs, laboratory values, or unstable medical or psychiatric illness
- Any disorder that may interfere with drug absorption.
- Clinically significant allergy or sensitivity to medications Positive test for human immunodeficiency virus (HIV) antibodies, Hepatitis B surface antigen, or Hepatitis C antibody.
- Pregnant or breast feeding.
- History of exposure to any radiation >15 mSv/year (e.g., occupational or radiation therapy) over the past year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Multiple Ascending Dose, [18F]MNI-659 PET-Imaging Study to Evaluate PDE10A Occupancy After Dosing With EVP-6308 in Healthy Subjects
This is an open-label, single-arm, multiple ascending dose Phase I study to assess the dose- and concentration-dependent displacement of [18F]MNI-659 [a PET tracer targeting phosphodiesterase 10 (PDE10)] by EVP-6308.
- Conditions
- Healthy
- Being tested
- EVP-6308
- Keywords
- Enzyme occupancy, Positron emission tomography (PET), Phosphodiesterase 10 inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVP-6308Drug
Arms 1, 2, 3, 4
| Study group | Role | What they receive |
|---|---|---|
| EVP-6308; Arm 1 | Experimental | low dose, Capsule, Twice Daily, Day 1 through Day 3 Receives: Drug: EVP-6308 |
| EVP-6308; Arm 2 | Experimental | low intermediate dose, Capsule, Twice Daily, Day 1 through Day 3 Receives: Drug: EVP-6308 |
| EVP-6308; Arm 3 | Experimental | high intermediate dose, Capsule, Once Daily, Day 1 through Day 3 Receives: Drug: EVP-6308 |
| EVP-6308; Arm 4 | Experimental | high dose, Capsule, Once Daily, Day 1 through Day 3 Receives: Drug: EVP-6308 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target occupancy of [18F]MNI-659.
Change in binding potential.
Measured: Baseline and Day 3
Secondary outcomes (2)
Safety of EVP-6308 as assessed by adverse events, vital signs, clinical laboratory tests, C-SSRS, and electrocardiogram (ECG).
The following will be evaluated: clinical laboratory evaluations (chemistry, hematology, coagulation and urinalysis), physical examination, directed neurological examination, vital signs, orthostatic blood pressure, 12-lead ECG, and assessment for suicidality. Adverse events and concomitant medications will be collected from the time of signing the informed consent.
Measured: Baseline to Day 4 or Early Termination
Pharmacokinetics of EVP-6308 and EVP-6308 N-oxide.
Pharmacokinetic parameters to be determined include Cmax, Tmax, t1/2, and CL/F.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- FORUM Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001389
- Sponsor's protocol ID
- EVP-6308-002
- Status last verified
- Oct 2014
- First submitted
- 27 Nov 2013
- Last updated
- 10 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multiple Ascending Dose, [18F]MNI-659 PET-Imaging Study to Evaluate PDE10A Occupancy After Dosing With EVP-6308 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02001389
- Acronym / sponsor ID
- EVP-6308-002
- Conditions
- Healthy
- Keywords
- Enzyme occupancy, Positron emission tomography (PET), Phosphodiesterase 10 inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- FORUM Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (actual)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, single-arm, multiple ascending dose Phase I study to assess the dose- and concentration-dependent displacement of [18F]MNI-659 [a PET tracer targeting phosphodiesterase 10 (PDE10)] by EVP-6308.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EVP-6308; Arm 1 | Experimental | Drug: EVP-6308low dose, Capsule, Twice Daily, Day 1 through Day 3 |
| EVP-6308; Arm 2 | Experimental | Drug: EVP-6308low intermediate dose, Capsule, Twice Daily, Day 1 through Day 3 |
| EVP-6308; Arm 3 | Experimental | Drug: EVP-6308high intermediate dose, Capsule, Once Daily, Day 1 through Day 3 |
| EVP-6308; Arm 4 | Experimental | Drug: EVP-6308high dose, Capsule, Once Daily, Day 1 through Day 3 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male or female volunteers, 18 to 50 years of age
Key exclusion criteria (5 listed)
- Clinically significant abnormalities on physical examination, medical history, ECG , vital signs, laboratory values, or unstable medical or psychiatric illness
- Any disorder that may interfere with drug absorption.
- Clinically significant allergy or sensitivity to medications Positive test for human immunodeficiency virus (HIV) antibodies, Hepatitis B surface antigen, or Hepatitis C antibody.
- Pregnant or breast feeding.
- History of exposure to any radiation >15 mSv/year (e.g., occupational or radiation therapy) over the past year.
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 |
|---|---|---|
| EVP-6308Arms 1, 2, 3, 4 | Drug | EVP-6308; Arm 1, EVP-6308; Arm 2, EVP-6308; Arm 3, EVP-6308; Arm 4 |
Primary outcome
Target occupancy of [18F]MNI-659.
Time frame: Baseline and Day 3
Change in binding potential.
2 secondary outcomes
Safety of EVP-6308 as assessed by adverse events, vital signs, clinical laboratory tests, C-SSRS, and electrocardiogram (ECG).
Time frame: Baseline to Day 4 or Early Termination
Pharmacokinetics of EVP-6308 and EVP-6308 N-oxide.
Time frame: Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EVP-6308 in people with Healthy, run by FORUM Pharmaceuticals Inc 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 1 inclusion and 5 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 10 Oct 2014. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Target occupancy of [18F]MNI-659. (time frame: Baseline and Day 3). 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 10 Oct 2014.