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

NCT01774045 | Completed Phase 1 Results DMC

• 1 other identifier: Phase I study of PDC-1421
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Major depressive disorder; Depression

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

PDC-1421

EXPERIMENTAL

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 control

PLACEBO COMPARATOR

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

Interventions

PDC-1421 DRUG

PDC-1421

Placebo DRUG

Placebo control

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• BioLite, Inc.: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Cheng-Ta Li
• Organization: Taipei Veterans General Hospital

on5083@msn.com

886-2-2871-2121

Study Officials

• Cheng-Ta Li, MD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

• Tung-Ping Su, M.D

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2013
• First Posted: January 23, 2013
• Study Start: November 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 13, 2020
• Results First Posted: September 22, 2014

Record last verified: 2014-09

Locations

TW (1)