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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01774045

Enrollment

Registered

2013-01-23

Start date

2012-11-30

Completion date

2013-07-31

Last updated

2020-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Major depressive disorder, Depression

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.

Detailed description

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

Interventions

DRUGPDC-1421

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

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

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Dose Limiting Toxicity of Physical Examination	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	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	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	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.
Number of Dose Limiting Toxicity of Columbia-Suicide Severity Rating Scale (C-SSRS)	baseline to 72 hours	C-SSRS is composed of suicidal ideation, intensity of ideation and suicidal behavior and measured at each visit.

Countries

Taiwan

Participant flow

Participants by arm

Arm	Count
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. PDC-1421	23
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. Placebo	7
Total	30

Baseline characteristics

Characteristic	PDC-1421	Placebo Control	Total
Age, Continuous	26.7 years STANDARD_DEVIATION 3.3	27.2 years STANDARD_DEVIATION 3.5	26.8 years STANDARD_DEVIATION 3.3
Region of Enrollment Taiwan	23 participants	7 participants	30 participants
Sex: Female, Male Female	9 Participants	1 Participants	10 Participants
Sex: Female, Male Male	14 Participants	6 Participants	20 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	3 / 23	2 / 7
serious Total, serious adverse events	0 / 23	0 / 7

Outcome results

Primary

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.