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CompletedNCT01774045Updated Aug 13, 2020Results posted

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

A Phase 1 interventional study of PDC-1421 and Placebo in Major Depressive Disorder, sponsored by BioLite, Inc.. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-13.

Sponsored by BioLite, Inc. · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Major Depressive Disorder

Keywords

  • Major depressive disorder
  • Depression
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 30 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

BioLite, Inc. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
30 participants (actual)

Study arms

  • 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

Interventions

  • DrugPDC-1421
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline to 72 hours

  2. 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.

    Time frame: baseline to 72 hours

  3. 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.

    Time frame: baseline to 72 hours

  4. 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.

    Time frame: baseline to 72 hours

  5. 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.

    Time frame: baseline to 72 hours

07

Results

Posted Sep 22, 2014

Participant flow

Participant flow — Overall Study
MilestonePDC-1421Placebo Control
Started237
Completed237
Not completed00

Outcome measures

PrimaryNumber 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.

Time frame:
baseline to 72 hours
Reported as:
Number · participants
Number of Dose Limiting Toxicity of Physical Examination
participantsPDC-1421Placebo Control
Number of Dose Limiting Toxicity of Physical Examination00
PrimaryNumber 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.

Time frame:
baseline to 72 hours
Reported as:
Number · participants
Number of Dose Limiting Toxicity of Electrocardiograph
participantsPDC-1421Placebo Control
Number of Dose Limiting Toxicity of Electrocardiograph00
PrimaryNumber 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.

Time frame:
baseline to 72 hours
Reported as:
Number · participants
Number of Dose Limiting Toxicity of Vital Sign
participantsPDC-1421Placebo Control
Number of Dose Limiting Toxicity of Vital Sign00
PrimaryNumber 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.

Time frame:
baseline to 72 hours
Reported as:
Number · participants
Number of Dose Limiting Toxicity of Laboratory Values
participantsPDC-1421Placebo Control
Number of Dose Limiting Toxicity of Laboratory Values02
PrimaryNumber 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.

Time frame:
baseline to 72 hours
Reported as:
Number · participants
Number of Dose Limiting Toxicity of Columbia-Suicide Severity Rating Scale (C-SSRS)
participantsPDC-1421Placebo Control
Number of Dose Limiting Toxicity of Columbia-Suicide Severity Rating Scale (C-SSRS)00

Adverse events

Collected over 72 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PDC-1421—0/23 (0%)3/23 (13%)
Placebo Control—0/7 (0%)2/7 (28.6%)
Most frequent other events
Most frequent other events
EventPDC-1421Placebo Control
Abdominal fullnessGastrointestinal disorders2/231/7
DrowsinessNervous system disorders0/231/7
SleepinessNervous system disorders1/231/7
ConstipationGastrointestinal disorders1/230/7
Oral ulcerNervous system disorders1/230/7

Baseline characteristics

One subject administrated with 380mg PDC-1421 lost baseline values of hematology and blood chemistry due to hemolysis and the problem never happens again after the nurse corrected her method of drawing blood. We reported this situation to DSMB and they suggested the remaining data to be included in ITT data set and agreed to enroll new subjects.

Age, Continuous
Age, Continuous(years)PDC-1421Placebo ControlTotal
Mean26.7 ± 3.327.2 ± 3.526.8 ± 3.3
Sex: Female, Male
Sex: Female, Male(Participants)PDC-1421Placebo ControlTotal
Female9110
Male14620
Region of Enrollment
Region of Enrollment(participants)PDC-1421Placebo ControlTotal
Taiwan23730
08

Study locations

1 site
  • Taipei Veterans General Hospital
    Taipei, 112, Taiwan
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01774045
Lead sponsor
BioLite, Inc.
Responsible party
Sponsor
First posted
Jan 23, 2013
Start date
Nov 2012
Primary completion
Jul 2013
Completion
Jul 2013
Results posted
Sep 22, 2014
Last update
Aug 13, 2020

Study contacts

Cheng-Ta Li, MD
principal investigator · Taipei Veterans General Hospital, Taiwan
Tung-Ping Su, M.D
principal investigator · Taipei Veterans General Hospital, Taiwan

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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