Back to resultsA Dose Escalation Phase I Study of PDC-1421 Capsule Targeting in Depression
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
PDC-1421
Placebo
Sponsored by
About this trial
This is an interventional other trial for Major Depressive Disorder focused on measuring Major depressive disorder, Depression
Eligibility Criteria
Inclusion Criteria:
- Aged 20-65 years.
- Subjects must be able to understand and willing to sign informed consent.
- Female subjects of child-bearing potential must test negative to pregnancy and use appropriate birth control method from the beginning of study to the 15 days later after ending of study.
- Laboratory data: red blood cell count(RBC),white blood cell count(WBC), platelets, hematocrit, hemoglobin, prothrombin time(PT), partial thromboplastin time (aPTT),aspartate transaminase(AST),alanine aminotransferase(ALT), Lactate dehydrogenase(LDH), total bilirubin, blood urea nitrogen(BUN),serum creatinine, free thyroxine (FT4), thyroid-stimulating hormone (TSH) level,sodium, potassium, calcium, glucose, are all within the normal range.
- No significantly abnormal findings on physical examination, ECG and vital sign.
Exclusion Criteria:
- With any clinically significant neurological, gastrointestinal, renal, hepatic,cardiovascular, respiratory, metabolic, endocrine, hematological or other major disorders as determined by the Investigator.
- A positive drug screen.
- Any mental disorder diagnosed by board-certificated psychiatrist through detailed diagnostic interview.
- Any history of suicidal behavior in the past 6 months when evaluated by the C-SSRS.
- The intensity of suicidal ideation in the past 6 months is no less than 4 defined by the C-SSRS.
- Have received any prescribed medicine, investigational drug or any non prescribed medicine (including herbal remedies) with 14 days prior to enroll this study.
Sites / Locations
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PDC-1421
Placebo control
Arm Description
Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.
Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.
Outcomes
Primary Outcome Measures
Number of Dose Limiting Toxicity of Physical Examination
Physical examination, including skin, head, neck, eyes, ears, nose, throat, heart, lungs, abdomen (liver and spleen), neurological examination, lymph node and extremities, is measured at each visit from screening to follow-up.
Number of Dose Limiting Toxicity of Electrocardiograph
Electrocardiograph (ECG) is measured at each visit. At visit 2, subjects were measured at 1,2, 4, 8, 12 and 24 hours after drug administration.
Number of Dose Limiting Toxicity of Vital Sign
Vital sign, including heart rate, blood pressure and body temperature, are measured at each visit and at 1,2,3,4,8,12 and 24 hours after drug administration.
Number of Dose Limiting Toxicity of Laboratory Values
Laboratory tests are composed of hematology and blood chemistry and measured at each visit. Hematology are composed of RBC, WBC, platelets, hematocrit, hemoglobin, prothrombin time (PT) and partial thromboplastin time (aPTT). Blood chemistry are composed of AST, ALT, LDH, total bilirubin, BUN, serum creatinine, free thyroxine (FT4), TSH, sodium, calcium, potassium, glucose, LDL, HDL, cholesterol and HbA1c.
Number of Dose Limiting Toxicity of Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS is composed of suicidal ideation, intensity of ideation and suicidal behavior and measured at each visit.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01774045
Brief Title
A Dose Escalation Phase I Study of PDC-1421 Capsule Targeting in Depression
Official Title
A Dose Escalation Phase I Study of PDC-1421 Capsule to Evaluate the Safety in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioLite, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety of PDC-1421 Capsule in healthy subject, find the effective adequate dose for the next stage of the study, and accumulate information of possible mechanism of its anti-depressive effect.
Detailed Description
Outcome measures: Physical examination, Vital sign, Electrocardiograph (ECG), Hematology, Blood chemistry, AEs/SAEs monitoring and Columbia-Suicide Severity Rating Scale (C-SSRS)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major depressive disorder, Depression
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PDC-1421
Arm Type
Experimental
Arm Description
Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.
Arm Title
Placebo control
Arm Type
Placebo Comparator
Arm Description
Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.
Intervention Type
Drug
Intervention Name(s)
PDC-1421
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Dose Limiting Toxicity of Physical Examination
Description
Physical examination, including skin, head, neck, eyes, ears, nose, throat, heart, lungs, abdomen (liver and spleen), neurological examination, lymph node and extremities, is measured at each visit from screening to follow-up.
Time Frame
baseline to 72 hours
Title
Number of Dose Limiting Toxicity of Electrocardiograph
Description
Electrocardiograph (ECG) is measured at each visit. At visit 2, subjects were measured at 1,2, 4, 8, 12 and 24 hours after drug administration.
Time Frame
baseline to 72 hours
Title
Number of Dose Limiting Toxicity of Vital Sign
Description
Vital sign, including heart rate, blood pressure and body temperature, are measured at each visit and at 1,2,3,4,8,12 and 24 hours after drug administration.
Time Frame
baseline to 72 hours
Title
Number of Dose Limiting Toxicity of Laboratory Values
Description
Laboratory tests are composed of hematology and blood chemistry and measured at each visit. Hematology are composed of RBC, WBC, platelets, hematocrit, hemoglobin, prothrombin time (PT) and partial thromboplastin time (aPTT). Blood chemistry are composed of AST, ALT, LDH, total bilirubin, BUN, serum creatinine, free thyroxine (FT4), TSH, sodium, calcium, potassium, glucose, LDL, HDL, cholesterol and HbA1c.
Time Frame
baseline to 72 hours
Title
Number of Dose Limiting Toxicity of Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
C-SSRS is composed of suicidal ideation, intensity of ideation and suicidal behavior and measured at each visit.
Time Frame
baseline to 72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged 20-65 years.
Subjects must be able to understand and willing to sign informed consent.
Female subjects of child-bearing potential must test negative to pregnancy and use appropriate birth control method from the beginning of study to the 15 days later after ending of study.
Laboratory data: red blood cell count(RBC),white blood cell count(WBC), platelets, hematocrit, hemoglobin, prothrombin time(PT), partial thromboplastin time (aPTT),aspartate transaminase(AST),alanine aminotransferase(ALT), Lactate dehydrogenase(LDH), total bilirubin, blood urea nitrogen(BUN),serum creatinine, free thyroxine (FT4), thyroid-stimulating hormone (TSH) level,sodium, potassium, calcium, glucose, are all within the normal range.
No significantly abnormal findings on physical examination, ECG and vital sign.
Exclusion Criteria:
With any clinically significant neurological, gastrointestinal, renal, hepatic,cardiovascular, respiratory, metabolic, endocrine, hematological or other major disorders as determined by the Investigator.
A positive drug screen.
Any mental disorder diagnosed by board-certificated psychiatrist through detailed diagnostic interview.
Any history of suicidal behavior in the past 6 months when evaluated by the C-SSRS.
The intensity of suicidal ideation in the past 6 months is no less than 4 defined by the C-SSRS.
Have received any prescribed medicine, investigational drug or any non prescribed medicine (including herbal remedies) with 14 days prior to enroll this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng-Ta Li, MD
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tung-Ping Su, M.D
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Dose Escalation Phase I Study of PDC-1421 Capsule Targeting in Depression
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