Major Depressive DisorderPhase 1NCT01774045

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

A Phase 1 study testing PDC-1421 in people with Major Depressive Disorder, run by BioLite, Inc. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 more about this study

Who is it for?: Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Major Depressive Disorder
What is being tested?: PDC-1421
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteTaiwan
Study dates: Nov 2012to Jul 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Taipei Veterans General Hospital
Taipei, 112

Other trials in Taiwan

About this study

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

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)

Conditions: Major Depressive Disorder
Being tested: PDC-1421, Placebo
Keywords: Major depressive disorder, Depression
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PDC-1421Drug
PlaceboDrug

Study groups in NCT01774045
Study group	Role	What they receive
PDC-1421	Experimental	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. Receives: Drug: PDC-1421
Placebo control	Placebo comparator	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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: baseline to 72 hours
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.
Measured: baseline to 72 hours
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.
Measured: baseline to 72 hours
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.
Measured: baseline to 72 hours
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.
Measured: baseline to 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Jul 2013

First posted23 Jan 2013 (estimated)
Study startNov 2012
Primary completionJul 2013
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01774045
Sponsor's protocol ID: Phase I study of PDC-1421
Status last verified: Sep 2014
First submitted: 20 Jan 2013
Last updated: 13 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose Escalation Phase I Study of PDC-1421 Capsule to Evaluate the Safety in Healthy Volunteers
ClinicalTrials.gov ID: NCT01774045
Acronym / sponsor ID: Phase I study of PDC-1421
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder, Depression
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: BioLite, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 23 Jan 2013 (estimated)
Results: Posted 22 Sep 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
PDC-1421	Experimental	Drug: PDC-1421Dosage 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.
Placebo control	Placebo comparator	Drug: PlaceboDosage 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.

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PDC-1421	Drug	PDC-1421
Placebo	Drug	Placebo control

Primary outcome

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 and HbA1c.
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.

Results and safety

Results posted to the registry on 22 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PDC-1421	23	23
Placebo Control	7	7

Primary outcome: Number of Dose Limiting Toxicity of Physical Examination

Time frame: baseline to 72 hours. Number. Unit: participants

Measure	PDC-1421 n = 23	Placebo Control n = 7
Value	0	0

Primary outcome: Number of Dose Limiting Toxicity of Electrocardiograph

Time frame: baseline to 72 hours. Number. Unit: participants

Measure	PDC-1421 n = 23	Placebo Control n = 7
Value	0	0

Primary outcome: Number of Dose Limiting Toxicity of Vital Sign

Time frame: baseline to 72 hours. Number. Unit: participants

Measure	PDC-1421 n = 23	Placebo Control n = 7
Value	0	0

Primary outcome: Number of Dose Limiting Toxicity of Laboratory Values

Time frame: baseline to 72 hours. Number. Unit: participants

Measure	PDC-1421 n = 23	Placebo Control n = 7
Value	0	2

Adverse events

Time frame: 72 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PDC-1421	0 of 23 (0%)	3 of 23 (13%)	Not reported
Placebo Control	0 of 7 (0%)	2 of 7 (28.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Major Depressive Disorder

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cheng-Ta Li, MD principal investigator

Taipei Veterans General Hospital, Taiwan

Tung-Ping Su, M.D principal investigator

Taipei Veterans General Hospital, Taiwan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PDC-1421 in people with Major Depressive Disorder, run by BioLite, Inc. at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Dose Limiting Toxicity of Physical Examination (time frame: baseline to 72 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01774045.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.