NCT01774747
Terminated
Phase 1
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Oral Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of DSP-1053 in Healthy Subjects and in Subjects With Major Depressive Disorder
Overview
- Phase
- Phase 1
- Intervention
- DSP-1053
- Conditions
- Healthy
- Sponsor
- Sumitomo Pharma America, Inc.
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- To reach minimumally intolerable dose based on stopping criteria
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
Brief Summary
Double-blind, placebo-controlled, multiple ascending oral dose evaluation of the safety, tolerability, and pharmacokinetics of DSP 1053 and its metabolites in healthy subjects and in subjects with major depressive disorder
Detailed Description
This study will be conducted at a single site as a double-blind, placebo-controlled, mulitple ascending oral doses evaluation of the safety, tolerability, and pharmacokinetics of DSP-1053 and its metabolites in healthy subjects with Major depressive disorder after the minimumally intolerated dose is reached in healthy subjects
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy Subjects:
- •Be able to understand and willing to sign the Informed Consent Form, and capable of providing written authorization for use and disclosure of protected health information per requirements of 45 Code of Federal Regulations (CFR) 164.508 (Health Information Portability and Accountability Act \[HIPAA\]).
- •Be healthy male or female subjects between 18 and 50 years of age (inclusive). Have a BMI 18 and 33 kg/m
- •Have no clinically relevant abnormal laboratory values at screening and Day -
- •Have no clinically relevant findings from vital sign measurements at screening and check-in.
- •Have no clinically relevant findings from physical examination at screening and check in.
- •Have a negative urine drug of abuse test (cannabinoids, barbiturates, cocaine, opiates, benzodiazepines, phencyclidine, and methadone) and negative cotinine test at screening and check in.
- •Have a negative alcohol breath test at screening and check in. Have a negative Hepatitis B surface antigen, Hepatitis C antibody, and human immunodeficiency virus (HIV) antibody tests at screening.
- •Have normal hepatic function \[aspartate transaminase (AST), bilirubin, and alanine transaminase (ALT)\] and renal function (creatinine clearance greater than 80 mL/min as assessed by Cockcroft Gault equation using serum creatinine) at screening and Day
- •Be females who are of childbearing potential:
Exclusion Criteria
- •Healthy Subjects
- •Significant history or clinical manifestations of any acute or chronic condition that in the opinion of the PI, would limit the subject's ability to complete and/or participate in the study:
- •metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders; drug hypersensitivity; stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (appendectomy, hernia repair, and/or cholecystectomy will be allowed at the discretion of the PI); abnormal ECG, which, in the PI's opinion, is clinically significant; known or suspected alcohol or substance abuse/ dependence within one year prior to check in; movement disorders including tremor; lifetime or family history of seizures or a febrile seizure. Poor peripheral venous access. Does not tolerate venipuncture. Donation of blood from 28 days prior to screening through study completion, inclusive.
- •Receipt of blood products within 2 months prior to check in. Any acute or chronic condition that, in the opinion of the PI, would limit the subject's ability to complete and/or participate in this clinical study.
- •Female subjects with menstrual dysfunction. Considered by the PI to be at imminent risk of suicide or injury to self, others, or property.
- •Subject answers "yes" to "Suicidal Ideation" Items 4 or 5 on the CSSRS at screening.
- •Subjects who, by history, have smoked or used tobacco products within 60 days from screening until study follow up.
- •Consumption of food or beverages containing alcohol, grapefruit, or caffeine within 72 hours prior to check in and until discharge from the study site, unless deemed acceptable by the PI.
- •Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half lives or 3 months prior to check-in, whichever is longer.
- •Taken any drug(s) known to be clinically relevant cytochrome P450 2D6 (CYP2D6), or cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 28 days prior to the first DSP 1053 dose and during the study conduct through follow up.
Arms & Interventions
DSP-1053
DSP-1053 10, 15, 20, 30, 45, 60, 90 mg once daily for 14 days
Intervention: DSP-1053
DSP-1053
DSP-1053 10, 15, 20, 30, 45, 60, 90 mg once daily for 14 days
Intervention: Placebo
Placebo
Placebo 10, 15, 20, 30, 45, 60, 90 mg once daily for 14 days
Intervention: DSP-1053
Placebo
Placebo 10, 15, 20, 30, 45, 60, 90 mg once daily for 14 days
Intervention: Placebo
Outcomes
Primary Outcomes
To reach minimumally intolerable dose based on stopping criteria
Time Frame: 14 days
* At least 50% of subjects within a cohort at dose level experience multiple moderate drug related adverse events or one severe drug-related adverse event * one drug related serious adverse event within a cohort at dose level * seizure of any severity or seriousness is observed in a subject who received DSP-1053 * Mean plasma DSR_22898 Cmax greater or equal to 32ng/ml for a cohort
Secondary Outcomes
- Characterize the pharmacodynamic relationship based on serotonin transporter occupancy of DSP-1053 following multiple oral doses of DSP-1053 in healthy subjects and major depressive disorder subjects(14 days)
- To characterize exposure of DSP-1053 and its metabolites (AUC, Cmax and Tmax) after multiple ascending dose of DSP-1053(14 days)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese DescentHealthy ParticipantsNCT05546151Bristol-Myers Squibb24
Terminated
Phase 1
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-553 in Healthy Volunteers and in Subjects With Psoriasis and Efficacy of ABBV-553 in Subjects With PsoriasisPsoriasisNCT03145948AbbVie12
Completed
Phase 1
Study Evaluating the Safety of Lecozotan SR in Healthy Young and Elderly SubjectsAlzheimer DiseaseNCT00366483Wyeth is now a wholly owned subsidiary of Pfizer40
Completed
Phase 1
Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses in HealthyHealthy SubjectsOsteoarthritisNCT00380900Wyeth is now a wholly owned subsidiary of Pfizer
Completed
Phase 1
PAC-14028 in Healthy Male VolunteersHealthyNCT01264224Amorepacific Corporation60