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NCT Number: NCT01774045

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

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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

PDC-1421

Drug

Placebo

Drug

Primary outcomes

  1. Number of Dose Limiting Toxicity of Physical Examination

    Time frame: baseline to 72 hours

    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.

  2. Number of Dose Limiting Toxicity of Electrocardiograph

    Time frame: baseline to 72 hours

    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.

  3. Number of Dose Limiting Toxicity of Vital Sign

    Time frame: baseline to 72 hours

    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.

  4. Number of Dose Limiting Toxicity of Laboratory Values

    Time frame: baseline to 72 hours

    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.

  5. Number of Dose Limiting Toxicity of Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: baseline to 72 hours

    C-SSRS is composed of suicidal ideation, intensity of ideation and suicidal behavior and measured at each visit.

Sponsors and collaborators

Lead sponsor

BioLite, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 23, 2013
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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