Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Outcome measures: Physical examination, Vital sign, Electrocardiograph (ECG), Hematology, Blood chemistry, AEs/SAEs monitoring and Columbia-Suicide Severity Rating Scale (C-SSRS)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDC-1421 | Experimental | 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. |
|
| Placebo control | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDC-1421 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline to 72 hours |
| 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. | baseline to 72 hours |
| 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. | baseline to 72 hours |
| 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. | baseline to 72 hours |
| 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. | baseline to 72 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cheng-Ta Li, MD | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Tung-Ping Su, M.D | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PDC-1421 | 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. PDC-1421 |
| FG001 | Placebo Control | 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. Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
One subject administrated with 380mg PDC-1421 lost baseline values of hematology and blood chemistry due to hemolysis and the problem never happens again after the nurse corrected her method of drawing blood. We reported this situation to DSMB and they suggested the remaining data to be included in ITT data set and agreed to enroll new subjects.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PDC-1421 | 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. PDC-1421 |
| BG001 | Placebo Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | baseline to 72 hours |
|
72 hours
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PDC-1421 | 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 observation from baseline to the following 72 hours |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal fullness | Gastrointestinal disorders | Non-systematic Assessment | This adverse event is mild and 25-50% related to the study drug by principal investigator's judgement. The subjects were recovered during the trial and without treatment intervention. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cheng-Ta Li | Taipei Veterans General Hospital | 886-2-2871-2121 | 7027 | on5083@msn.com |
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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. Placebo |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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. | Posted | Number | participants | baseline to 72 hours |
|
|
|
| Primary | 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. | Posted | Number | participants | baseline to 72 hours |
|
|
|
| Primary | 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. | Posted | Number | participants | baseline to 72 hours |
|
|
|
| Primary | 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. | Posted | Number | participants | baseline to 72 hours |
|
|
|
| 0 |
| 23 |
| 3 |
| 23 |
| EG001 | Placebo Control | 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 observation from baseline to the following 72 hours | 0 | 7 | 2 | 7 |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment | This adverse event is mild and 50% related to the study drug by principal investigator's judgement. The subject was recovered during the trial and without treatment intervention. |
|
| Drowsiness | Nervous system disorders | Non-systematic Assessment | The adverse event is mild and 25-30% related to the study drug by principal investigator's judgement. The subject was recovered during the trial and without treatment intervention. |
|
| Sleepiness | Nervous system disorders | Non-systematic Assessment | The adverse event is mild and 50% related to the study drug by principal investigator's judgement. The subjects were recovered during the trial and without treatment intervention. |
|
| Oral ulcer | Nervous system disorders | Non-systematic Assessment | The adverse event is mild and 25-30% related to the study drug by principal investigator's judgement. The subject was recovered after one week of the end of trial and without treatment intervention. |
|
Not provided
Not provided
| D001519 |
| Behavior |