Clinical trial NCT01774045: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder
Depression
Lead sponsor: BioLite, Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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)

Eligibility 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.

Primary outcomes:
measure: Number of Dose Limiting Toxicity of Physical Examination
timeFrame: baseline to 72 hours
measure: Number of Dose Limiting Toxicity of Electrocardiograph
timeFrame: baseline to 72 hours
measure: Number of Dose Limiting Toxicity of Vital Sign
timeFrame: baseline to 72 hours
measure: Number of Dose Limiting Toxicity of Laboratory Values
timeFrame: baseline to 72 hours
measure: Number of Dose Limiting Toxicity of Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: baseline to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Cheng-Ta Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Taipei Veterans General Hospital, Taiwan
name: Tung-Ping Su, M.D
role: PRINCIPAL_INVESTIGATOR
References: