NCT01774045

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

Completed Phase 1 Results posted Last updated 11 August 2020

What this trial tests

Phase 1 trial testing PDC-1421 in Major Depressive Disorder in 30 participants. Completed in 1 July 2013.

Timeline

1 November 2012

Primary endpoint
1 July 2013

1 July 2013

Quick facts

Lead sponsor	BioLite, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Enrollment	30
Start date	1 November 2012
Primary completion	1 July 2013
Estimated completion	1 July 2013
Sites	1 location across Taiwan

Drugs / interventions tested

• PDC-1421
• Placebo

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

BioLite, Inc. — full company profile →

Who can join

Adults 20 to 65, any sex, with Major Depressive Disorder. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.
• 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.
• 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.
• 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 a
• 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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.