A Dose Escalation Phase I Study of PDC-1421 Capsule Targeting in Depression
|ClinicalTrials.gov Identifier: NCT01774045|
Recruitment Status : Completed
First Posted : January 23, 2013
Results First Posted : September 22, 2014
Last Update Posted : September 22, 2014
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: PDC-1421 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Dose Escalation Phase I Study of PDC-1421 Capsule to Evaluate the Safety in Healthy Volunteers|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
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 Comparator: 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.
- Number of Dose Limiting Toxicity of Physical Examination [ Time Frame: baseline to 72 hours ]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 [ Time Frame: baseline to 72 hours ]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 [ Time Frame: baseline to 72 hours ]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 [ Time Frame: baseline to 72 hours ]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) [ Time Frame: baseline to 72 hours ]C-SSRS is composed of suicidal ideation, intensity of ideation and suicidal behavior and measured at each visit.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774045
|Taipei Veterans General Hospital|
|Taipei, Taiwan, 112|
|Principal Investigator:||Cheng-Ta Li, MD||Taipei Veterans General Hospital, Taiwan|
|Principal Investigator:||Tung-Ping Su, M.D||Taipei Veterans General Hospital, Taiwan|