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

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Placebo; Drug: PDC-1421

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: January 20, 2013
• First Submitted That Met QC Criteria: January 22, 2013
• First Posted (Estimate): January 23, 2013

Study Record Updates

• Last Update Posted (Actual): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Depression; Major depressive disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: Phase I study of PDC-1421