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A Dose Escalation Phase I Study of PDC-1421 Capsule Targeting in Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01774045
First Posted: January 23, 2013
Last Update Posted: September 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
BioLite, Inc.
  Purpose
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.

Condition Intervention Phase
Major Depressive Disorder Drug: PDC-1421 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
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

Further study details as provided by BioLite, Inc.:

Primary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: November 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: PDC-1421
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.
Drug: Placebo

Detailed Description:
Outcome measures: Physical examination, Vital sign, Electrocardiograph (ECG), Hematology, Blood chemistry, AEs/SAEs monitoring and Columbia-Suicide Severity Rating Scale (C-SSRS)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Aged 20-65 years.
  2. Subjects must be able to understand and willing to sign informed consent.
  3. 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.
  4. 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.
  5. No significantly abnormal findings on physical examination, ECG and vital sign.

Exclusion Criteria:

  1. With any clinically significant neurological, gastrointestinal, renal, hepatic,cardiovascular, respiratory, metabolic, endocrine, hematological or other major disorders as determined by the Investigator.
  2. A positive drug screen.
  3. Any mental disorder diagnosed by board-certificated psychiatrist through detailed diagnostic interview.
  4. Any history of suicidal behavior in the past 6 months when evaluated by the C-SSRS.
  5. The intensity of suicidal ideation in the past 6 months is no less than 4 defined by the C-SSRS.
  6. Have received any prescribed medicine, investigational drug or any non prescribed medicine (including herbal remedies) with 14 days prior to enroll this study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774045


Locations
Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Sponsors and Collaborators
BioLite, Inc.
Investigators
Principal Investigator: Cheng-Ta Li, MD Taipei Veterans General Hospital, Taiwan
Principal Investigator: Tung-Ping Su, M.D Taipei Veterans General Hospital, Taiwan
  More Information

Responsible Party: BioLite, Inc.
ClinicalTrials.gov Identifier: NCT01774045     History of Changes
Other Study ID Numbers: Phase I study of PDC-1421
First Submitted: January 20, 2013
First Posted: January 23, 2013
Results First Submitted: February 21, 2014
Results First Posted: September 22, 2014
Last Update Posted: September 22, 2014
Last Verified: September 2014

Keywords provided by BioLite, Inc.:
Major depressive disorder
Depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms