HealthyPhase 1NCT01531972

A Phase 1, Open-Label, Single-photon Emission Computed Tomography (SPECT) Study to Evaluate Serotonin and Dopamine Transporter Occupancy After Multiple Dose Administration of SEP-228432 to Achieve Steady State in Healthy Subjects

A Phase 1 study testing SEP-228432 in people with Healthy, run by Sumitomo Pharma America, Inc. 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

Search all trials

Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: SEP-228432
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Feb 2012to May 2012
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

Subject must give written informed consent prior to participation in the study.
Subject must be willing and able to comply with the study procedures and visit schedules and must be able to follow verbal and written instructions.
Male and female subjects between 18-50 years of age (inclusive) at the time of signing consent.
Subject must be judged to be in a condition of general good health (defined as the absence of any clinically relevant abnormalities as determined by the investigator), based on screening medical and psychiatric histories, physical examination, neurological examination, vital signs, clinical laboratory values (hematology, chemistry, and urinalysis), and a 12-lead ECG.
Subject, if female, must have a negative serum pregnancy test at screening. All subjects must be instructed to and agree to avoid pregnancy during the study and must be using an acceptable method of birth control: An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 30 days prior to screening and will continue its use throughout the study and for 30 days following study participation. Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study. Abstinence.
Subject must be willing to stay within the residential facility for the required period and must be willing to attend up to 3 additional outpatient visits.
Subject's body mass index (BMI) must be at least 16 kg/m2 but no more than 32 kg/m2.
Subject must be willing to refrain from strenuous activity during the course of the study.

Who cannot join

Subject has poor venous access that would cause difficulty for collecting blood samples.
Subject with a history of exposure to any radiation ≥ 15 mSv/year (eg, occupational or radiation therapy) within the previous year.
Subject has participated in an investigational drug study and received investigational drug within 30 days prior to signing informed consent (with the exception of previous SPECT imaging studies where the only investigational drug administered was a radiotracer), or is currently participating in another clinical trial.
Subject has any clinically significant unstable medical condition or any clinically significant chronic disease. Subject with evidence or history of a clinically significant hematological (including deep vein thrombosis) or bleeding disorder, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (except for untreated, asymptomatic allergies at time of dosing).
Subject has a history of severe or multiple allergic reactions to medications.
Subject has a history of hospitalization within 45 days prior to signing informed consent.

Show all 21Show fewer

Subject has a positive test for Hepatitis B surface antigen, Hepatitis C antibody, human immunodeficiency virus (HIV)-1, or HIV-2 antibody, or has a history of a positive result.
Subject has a presence or history of a medically diagnosed, clinically significant psychiatric disorder (including mental retardation).
Female subject who is pregnant or lactating.
Subject has a history of cancer (exception: basal cell carcinoma in remission).
Subject has experienced significant blood loss (≥ 473 mL) or donated blood within 60 days prior to signing informed consent; has donated plasma within 72 hours prior to signing informed consent; or intends to donate plasma or blood or undergo elective surgery during study participation or within 60 days after the last study visit.
Subject has a history of substance abuse or drug abuse within 12 months prior to signing informed consent or a positive drug screen at Visit 1.
Subject has a history of tobacco dependency or has used tobacco or nicotine within 30 days prior to signing informed consent (including pipe, cigar, patch, chewing tobacco, spray, inhaler, or gum) or a positive urine cotinine test at Visit 1.
Subject has a history of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months prior to signing informed consent.
Subject consumes more than 180 mg of caffeine per day (3 cups of coffee or equivalent in caffeinated beverages).
Subject has a disorder or history of a condition that may interfere with drug absorption, distribution, metabolism, or excretion or a clinically significant abnormality of the hepatic or renal system, or a history of malabsorption, or previous gastrointestinal surgery (eg, cholecystectomy, vagotomy, bowel resection, or any surgical procedure) that could affect drug absorption or metabolism, gastrointestinal motility, or pH.
Subject has a clinically significant abnormal 12-lead ECG that may jeopardize the subject's ability to complete the study or a Screening 12-lead ECG demonstrating any one of the following: heart rate > 100 beats per minute (bpm), QRS > 120 ms, QTc > 450 ms, or PR > 220 ms as determined by the investigator using the core laboratory ECG interpretation report.
Subject has used prescription or non-prescription drugs, vitamins, dietary or herbal supplements within 14 days prior to signing informed consent. Enzyme-inducing herbal supplements (eg, Metabolife™) must have been discontinued at least 30 days prior to signing informed consent.
Subject previously received study drug in this study.
Subject is a staff member or the relative of a staff member.
Subject is in the opinion of the investigator, unsuitable in any other way to participate in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Molecular NeuroImaging
New Haven, Connecticut, 06510

Other trials in United States

About this study

Read the detailed description

This is an open-label study investigating the relationship between SEP-228432 and SEP-228431 (the active metabolite of SEP-228432) plasma concentrations, SERT occupancy, and DAT occupancy, both measured by SPECT imaging using [123I]-2β-carbomethoxy-3β-(4-iodophenyl) tropane ([123I] β -CIT). Up to 3 sequential cohorts of 8 subjects each will have multiple dose administrations of SEP-228432. The target dose for the first cohort will be 200 mg. Dose selection for the remaining cohorts will be based on preliminary review of all available relevant data from prior dosing cohort(s).

Conditions: Healthy
Being tested: SEP-228432
Keywords: Single-photon Emission Computed Tomography, Healthy Volunteers, Tomography

What participants receive

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

SEP-228432Drug
40 mg, orally, once daily for 3 days followed by 200 mg orally, once daily for 5 days
SEP-228432Drug
40 mg orally once daily for 3 days followed by ≤ 300mg, orally once daily for 5 days

Study groups in NCT01531972
Study group	Role	What they receive
SEP-228432 (Cohort 1)	Experimental	Subjects will receive 40 mg of SEP-228432 (titration) orally once per day for 3 days; followed by (steady state) at a dose of 200 mg orally once per day for 5 days. Receives: Drug: SEP-228432
SEP-228432 (Cohort 2)	Experimental	Subjects will receive 40 mg of SEP-228432 (titration) orally once per day for 3 days followed by a dose (TBD) of SEP 228432 ≤ 300mg, orally once per day for 5 days. Receives: Drug: SEP-228432
SEP-228432 (Cohort 3)	Experimental	Subjects will receive 40 mg of SEP-228432 (titration) 40 mg of SEP 228432 orally once per day for 3 days followed by a dose (TBD) of SEP 228432 ≤ 300mg, orally once per day for 5 days. Receives: Drug: SEP-228432

What is being measured

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

SERT and DAT occupancy (% occupancy) achieved at steady-state concentrations of SEP-228432 and SEP-228431 in healthy subjects.
SERT and DAT occupancy (% occupancy) achieved at steady-state concentrations of SEP-228432 and SEP-228431 in healthy subjects.
Measured: Day 8 and 9

Secondary outcomes (1)

Incidence of treatment-emergent adverse events (TEAEs).
Incidence of treatment-emergent adverse events (TEAEs).
Measured: Up to Day 16

Timeline

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

Feb 2012May 2012

First posted13 Feb 2012 (estimated)
Study startFeb 2012
Primary completionMay 2012
Study completionMay 2012

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: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01531972
Sponsor's protocol ID: SEP432-102
Status last verified: Dec 2013
First submitted: 8 Feb 2012
Last updated: 9 Dec 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Single-photon Emission Computed Tomography (SPECT) Study to Evaluate Serotonin and Dopamine Transporter Occupancy After Multiple Dose Administration of SEP-228432 to Achieve Steady State in Healthy Subjects
ClinicalTrials.gov ID: NCT01531972
Acronym / sponsor ID: SEP432-102
Conditions: Healthy
Keywords: Single-photon Emission Computed Tomography, Healthy Volunteers, Tomography
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 13 Feb 2012 (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.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
SEP-228432 (Cohort 1)	Experimental	Drug: SEP-228432Subjects will receive 40 mg of SEP-228432 (titration) orally once per day for 3 days; followed by (steady state) at a dose of 200 mg orally once per day for 5 days.
SEP-228432 (Cohort 2)	Experimental	Drug: SEP-228432Subjects will receive 40 mg of SEP-228432 (titration) orally once per day for 3 days followed by a dose (TBD) of SEP 228432 ≤ 300mg, orally once per day for 5 days.
SEP-228432 (Cohort 3)	Experimental	Drug: SEP-228432Subjects will receive 40 mg of SEP-228432 (titration) 40 mg of SEP 228432 orally once per day for 3 days followed by a dose (TBD) of SEP 228432 ≤ 300mg, orally once per day for 5 days.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Subject must give written informed consent prior to participation in the study.
Subject must be willing and able to comply with the study procedures and visit schedules and must be able to follow verbal and written instructions.
Male and female subjects between 18-50 years of age (inclusive) at the time of signing consent.
Subject must be judged to be in a condition of general good health (defined as the absence of any clinically relevant abnormalities as determined by the investigator), based on screening medical and psychiatric histories, physical examination, neurological examination, vital signs, clinical laboratory values (hematology, chemistry, and urinalysis), and a 12-lead ECG.
Subject, if female, must have a negative serum pregnancy test at screening. All subjects must be instructed to and agree to avoid pregnancy during the study and must be using an acceptable method of birth control: An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 30 days prior to screening and will continue its use throughout the study and for 30 days following study participation. Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study. Abstinence.

Key exclusion criteria (21 listed)

Subject has poor venous access that would cause difficulty for collecting blood samples.
Subject with a history of exposure to any radiation ≥ 15 mSv/year (eg, occupational or radiation therapy) within the previous year.
Subject has participated in an investigational drug study and received investigational drug within 30 days prior to signing informed consent (with the exception of previous SPECT imaging studies where the only investigational drug administered was a radiotracer), or is currently participating in another clinical trial.
Subject has any clinically significant unstable medical condition or any clinically significant chronic disease. Subject with evidence or history of a clinically significant hematological (including deep vein thrombosis) or bleeding disorder, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (except for untreated, asymptomatic allergies at time of dosing).
Subject has a history of severe or multiple allergic reactions to medications.

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
SEP-22843240 mg, orally, once daily for 3 days followed by 200 mg orally, once daily for 5 days	Drug	SEP-228432 (Cohort 1)
SEP-22843240 mg orally once daily for 3 days followed by ≤ 300mg, orally once daily for 5 days	Drug	SEP-228432 (Cohort 2), SEP-228432 (Cohort 3)

Primary outcome

SERT and DAT occupancy (% occupancy) achieved at steady-state concentrations of SEP-228432 and SEP-228431 in healthy subjects.
Time frame: Day 8 and 9
SERT and DAT occupancy (% occupancy) achieved at steady-state concentrations of SEP-228432 and SEP-228431 in healthy subjects.

1 secondary outcome

Incidence of treatment-emergent adverse events (TEAEs).
Time frame: Up to Day 16

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 9 Dec 2013.

Related trials for Healthy

Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples

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 SEP-228432 in people with Healthy, run by Sumitomo Pharma America, 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 8 inclusion and 21 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 9 Dec 2013. 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?

SERT and DAT occupancy (% occupancy) achieved at steady-state concentrations of SEP-228432 and SEP-228431 in healthy subjects. (time frame: Day 8 and 9). 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 NCT01531972.

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 9 Dec 2013.