Trial Outcomes & Findings for A Dose Escalation Phase I Study of PDC-1421 Capsule Targeting in Depression (NCT NCT01774045)

NCT ID: NCT01774045

Last Updated: 2020-08-13

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 30 participants
• Primary outcome timeframe: baseline to 72 hours
• Results posted on: 2020-08-13

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	23	7
Overall Study COMPLETED	23	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	PDC-1421 n=23 Participants 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	Placebo Control n=7 Participants 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	Total n=30 Participants Total of all reporting groups
Age, Continuous	26.7 years STANDARD_DEVIATION 3.3 • n=5 Participants	27.2 years STANDARD_DEVIATION 3.5 • n=7 Participants	26.8 years STANDARD_DEVIATION 3.3 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment Taiwan	23 participants n=5 Participants	7 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	PDC-1421 n=23 Participants 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 observation from baseline to the following 72 hours	Placebo Control n=7 Participants 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 observation from baseline to the following 72 hours.
Number of Dose Limiting Toxicity of Physical Examination	0 participants	0 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	PDC-1421 n=23 Participants 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 observation from baseline to the following 72 hours	Placebo Control n=7 Participants 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 observation from baseline to the following 72 hours.
Number of Dose Limiting Toxicity of Electrocardiograph	0 participants	0 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	PDC-1421 n=23 Participants 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 observation from baseline to the following 72 hours	Placebo Control n=7 Participants 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 observation from baseline to the following 72 hours.
Number of Dose Limiting Toxicity of Vital Sign	0 participants	0 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	PDC-1421 n=23 Participants 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 observation from baseline to the following 72 hours	Placebo Control n=7 Participants 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 observation from baseline to the following 72 hours.
Number of Dose Limiting Toxicity of Laboratory Values	0 participants	2 participants

PRIMARY outcome

Timeframe: baseline to 72 hours

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

Outcome measures

Measure	PDC-1421 n=23 Participants 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 observation from baseline to the following 72 hours	Placebo Control n=7 Participants 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 observation from baseline to the following 72 hours.
Number of Dose Limiting Toxicity of Columbia-Suicide Severity Rating Scale (C-SSRS)	0 participants	0 participants

Adverse Events

PDC-1421

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo Control

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	PDC-1421 n=23 participants at risk 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 observation from baseline to the following 72 hours	Placebo Control n=7 participants at risk 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 observation from baseline to the following 72 hours
Gastrointestinal disorders Abdominal fullness	8.7% 2/23 • Number of events 2 • 72 hours	14.3% 1/7 • Number of events 1 • 72 hours
Gastrointestinal disorders Constipation	4.3% 1/23 • Number of events 1 • 72 hours	0.00% 0/7 • 72 hours
Nervous system disorders Drowsiness	0.00% 0/23 • 72 hours	14.3% 1/7 • Number of events 1 • 72 hours
Nervous system disorders Sleepiness	4.3% 1/23 • Number of events 1 • 72 hours	14.3% 1/7 • Number of events 1 • 72 hours
Nervous system disorders Oral ulcer	4.3% 1/23 • Number of events 1 • 72 hours	0.00% 0/7 • 72 hours

Additional Information

Dr. Cheng-Ta Li

Taipei Veterans General Hospital

Phone: 886-2-2871-2121

Email: on5083@msn.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place