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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by BioLite, Inc.
Sponsor:
Information provided by (Responsible Party):
BioLite, Inc.
ClinicalTrials.gov Identifier:
NCT01774045
First received: January 20, 2013
Last updated: January 24, 2013
Last verified: January 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:
  • Physical examination, Vital sign, ECG, Hematology, Blood chemistry, AEs/SAEs monitoring, C-SSRS [ Time Frame: observe for 72hr after taking drugs ] [ Designated as safety issue: Yes ]
    Safety endpoint is based on the measurement of physical examination, vital signs,laboratory data, Electrocardiograph(ECG), Columbia-Suicide Severity Rating Scale (C-SSRS) evaluation and number of adverse events(AEs) and serious adverse events (SAEs) during the study period.


Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: April 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

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774045

Locations
Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Contact: Hsien-Ming Wu    886-3-578-6976 ext 11    sonnywu@bioliteinc.com   
Contact: Yu-Han Lee    886-2-8751-8701 ext 22    lauryn1022@bioliteinc.com   
Principal Investigator: Cheng-Ta Li, MD         
Principal Investigator: Tung-Ping Su, M.D         
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

No publications provided

Responsible Party: BioLite, Inc.
ClinicalTrials.gov Identifier: NCT01774045     History of Changes
Other Study ID Numbers: Phase I study of PDC-1421
Study First Received: January 20, 2013
Last Updated: January 24, 2013
Health Authority: United States: Food and Drug Administration
Taiwan : Food and Drug Administration
Taiwan: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014