Phase 1
N=30
A Dose Escalation Phase I Study of PDC-1421 Capsule Targeting in Depression
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01774045 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Number of Dose Limiting Toxicity of Physical Examination — 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PDC-1421 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- BioLite, Inc.
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Dose Limiting Toxicity of Physical Examination |
0; 0 | — |
| PRIMARY Number of Dose Limiting Toxicity of Electrocardiograph |
0; 0 | — |
| PRIMARY Number of Dose Limiting Toxicity of Vital Sign |
0; 0 | — |
| PRIMARY Number of Dose Limiting Toxicity of Laboratory Values |
0; 2 | — |
| PRIMARY Number of Dose Limiting Toxicity of Columbia-Suicide Severity Rating Scale (C-SSRS) |
0; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01774045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.