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

Major Depressive Disorder Clinical Trial

Official title:

A Dose Escalation Phase I Study of PDC-1421 Capsule to Evaluate the Safety in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774045
• Other study ID #: Phase I study of PDC-1421
• Status: Completed
• Phase: Phase 1
• Start date: November 2012
• Est. completion date: July 2013

Study information

• Verified date: September 2014
• Source: BioLite, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• PDC-1421

• Placebo

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
BioLite, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	baseline to 72 hours
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.	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.	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.	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.	baseline to 72 hours