Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy

Keywords

Single-photon Emission Computed TomographyHealthy VolunteersTomography

Outcome Measures

Primary Outcomes (1)

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.
Day 8 and 9

Secondary Outcomes (1)

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

Study Arms (3)

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.

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.

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.

Interventions

SEP-228432Drug

40 mg, orally, once daily for 3 days followed by 200 mg orally, once daily for 5 days

SEP-228432 (Cohort 1)

SEP-228432Drug

40 mg orally once daily for 3 days followed by ≤ 300mg, orally once daily for 5 days

SEP-228432 (Cohort 2)SEP-228432 (Cohort 3)

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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.

Sponsors & Collaborators

Sumitomo Pharma America, Inc.
Industrylead

Study Sites (1)

Molecular NeuroImaging

New Haven, Connecticut, 06510, United States

Enrollment

30 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 8, 2012

First Posted

February 13, 2012

Study Start

February 2012

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

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.
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).
+6 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

SEP-228432 (Cohort 1)

SEP-228432 (Cohort 2)

SEP-228432 (Cohort 3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

SEP-228432 (Cohort 1)

SEP-228432 (Cohort 2)

SEP-228432 (Cohort 3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations