HealthyPhase 1MADNCT01774747
A 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
A Phase 1 study testing DSP-1053 in people with Healthy, run by Sumitomo Pharma America, Inc. at 1 site in United States.
Trial 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 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?
- DSP-1053
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Apr 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 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/m2. Have no clinically relevant abnormal laboratory values at screening and Day -1.
- 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.
Show all 26Show fewer
- 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 1.
- Be females who are of childbearing potential:
- have a negative serum hCG pregnancy test at screening and Day -1; willing to not breastfeed from Day -5 until 90 days after discharge from the study site;
- Be females who are:
- unable to have children (eg, post menopausal, tubal ligation, hysterectomy) OR willing to remain abstinent (not engage in sexual intercourse) from check in until 90 days after discharge from the study site.
- OR willing to use an effective method of double-barrier birth control (eg, partner using condom and female using diaphragm, contraceptive sponge, spermicide, or intrauterine device) from check-in until 90 days after discharge from the study site.
- Be males who:
- are sterile or willing to remain sexually abstinent or use an effective method of birth control (eg, condom) from check-in until 90 days after discharge from the study site.
- AND agree not to donate sperm during the study and for 90 days after discharge from the study site.
- Refrain from strenuous physical activity from 48 hours prior to check-in until discharge from the study site.
- Agree to remain housed at the study site for the clinical confinement of study and return for any visits required for additional safety or PK assessments.
- Agree to consume study meals per protocol.
- Subjects with MDD:
- In addition to inclusion criteria mentioned above for healthy subjects, the following inclusion criteria will be applied to subjects with MDD:
- Have the diagnosis of MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition; Text Revision (DSM IV TR) criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) diagnostic interview. This diagnosis will be confirmed by a psychiatrist or psychologist. The diagnosis should be supplemented (when possible) by confirmation of chart records or by a discussion with a treating healthcare professional or reliable informant. Diagnosis made by a psychologist must be reviewed by a psychiatrist.
- The subjects' current major depressive episode must be ≥ 4 weeks and < 2 years in duration.
- Are able to wash-out from prior antidepressant therapies by Day -1, are able to forego psychotherapy from Day -1 through Day 10, inclusive, and are deemed clinically stable by PI's assessment.
- May have a comorbid anxiety disorder such as generalized anxiety disorder (GAD) or social phobia but not obsessive compulsive disorder (OCD) as long as the comorbid anxiety disorder is not the major source of impairment.
- Have a stable living arrangement for at least 3 months prior to check in and agree to return to a similar living arrangement after discharge. This criterion is not meant to exclude subjects who have temporarily left a stable living environment. Such subjects remain eligible to participate in this study. Chronically homeless subjects should not be enrolled. The Medical Monitor should be consulted for individual cases as needed.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
- Taken any antihistamines within 14 days prior to check-in and during the study. Family history of prolonged QT interval (QTc) prolongation. Subjects, who by history, are at any risk for bleeding or have abnormal prothrombin values or currently use of anticoagulant treatment (such as warfarin) Clinically important folic acid or B12 abnormalities detected within 3 months before screening.
- Use of any prescription medications/products within 14 days prior to check in unless deemed acceptable by the PI.
- Subjects with MDD
- Except for Exclusion Criterion 18 mentioned above for healthy subjects all exclusion criteria will be applied and in addition the following exclusion criteria will be applied to subjects with MDD:
- History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder.
- Any current Axis I disorder other than major depressive disorder which is the focus of treatment.
- Substance or alcohol abuse in the last 3 months or substance or alcohol dependence in the last 12 months.
- Concomitant psychotropic medication, including herbals. Significant risk of violent behavior or a significant risk of suicidal behavior based on history or in the PI's judgment.
Trial locations and contacts
1 site in 1 country.
United States1 site
California Clinical Trials Medical Group
Glendale, California, 91206
About this study
Official title: 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
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
Read the 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
- Conditions
- Healthy
- Being tested
- DSP-1053, Placebo
- Keywords
- Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSP-1053Drug
DSP-1053 10, 15, 20, 30, 45, 60, 90 mg once daily for 14 days
PlaceboDrug
Placebo 10, 15, 20, 30, 45, 60, 90 mg once daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| DSP-1053 | Experimental | DSP-1053 10, 15, 20, 30, 45, 60, 90 mg once daily for 14 days Receives: Drug: DSP-1053; Drug: Placebo |
| Placebo | Placebo comparator | Placebo 10, 15, 20, 30, 45, 60, 90 mg once daily for 14 days Receives: Drug: DSP-1053; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To reach minimumally intolerable dose based on stopping criteria
- 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
Measured: 14 days
Secondary outcomes (2)
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
Measurement of inhibition of active [H]-5HT transport in cells expressing the human serotonin transporter.
Measured: 14 days
To characterize exposure of DSP-1053 and its metabolites (AUC, Cmax and Tmax) after multiple ascending dose of DSP-1053
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: This program was terminated for financial reasons
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, DSP-1053, Study director, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774747
- Sponsor's protocol ID
- D7750090
- Acronym
- MAD
- Status last verified
- Jun 2014
- First submitted
- 8 Jan 2013
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01774747
- Acronym / sponsor ID
- MAD / D7750090
- Conditions
- Healthy
- Keywords
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This program was terminated for financial reasons
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 24 Jan 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DSP-1053 | Experimental | Drug: DSP-1053, Drug: PlaceboDSP-1053 10, 15, 20, 30, 45, 60, 90 mg once daily for 14 days |
| Placebo | Placebo comparator | Drug: DSP-1053, Drug: PlaceboPlacebo 10, 15, 20, 30, 45, 60, 90 mg once daily for 14 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (26 listed)
- 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/m2. Have no clinically relevant abnormal laboratory values at screening and Day -1.
- 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.
Key exclusion criteria (18 listed)
- 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.
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 |
|---|---|---|
| DSP-1053DSP-1053 10, 15, 20, 30, 45, 60, 90 mg once daily for 14 days | Drug | DSP-1053, Placebo |
| PlaceboPlacebo 10, 15, 20, 30, 45, 60, 90 mg once daily for 14 days | Drug | DSP-1053, Placebo |
Primary outcome
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
2 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
Time frame: 14 days
To characterize exposure of DSP-1053 and its metabolites (AUC, Cmax and Tmax) after multiple ascending dose of DSP-1053
Time frame: 14 days
Results and safety
The study was stopped early (reason given: This program was terminated for financial reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Medical Director, DSP-1053 study director
Sumitomo Pharma America, Inc.
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 DSP-1053 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 26 inclusion and 18 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: stopped early, as of the sponsor's last update on 18 Jun 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: This program was terminated for financial reasons). Results are not available in the source record.
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?
To reach minimumally intolerable dose based on stopping criteria (time frame: 14 days). 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 18 Jun 2014.