Healthy VolunteerPhase 1NCT04418388
Pharmacokinetics and Safety of PBK-1801 After Single Oral Administration in Healthy Korean Women
A Phase 1 study testing PBK-1801 in people with Healthy Volunteer, run by Pharmbio Korea Co., Ltd. at 1 site in South Korea.
Trial summary
The primary objective of this study is to assess the pharmacokinetic characteristics after a single dose of oral PBK-1801 in healthy Korean women for preparing the bridging data for Koreans. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- PBK-1801
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Oct 2019to 23 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 Any age
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) between 19 and 30 kg/m²
- Subjects are to be in good general health according to medical history, physical examination, electrocardiograph (ECG) recording and clinical laboratory assessments showing no signs clinically significant pathology (A subject with a clinically insignificant abnormality may be included by the discretion of the investigator)
- Subjects are to have given their written informed consent to participate in the study and to abide by study restrictions
Who cannot join
- History or evidence of clinically significant cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, psychiatric or other major disease
- Subjects who have any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract other than uncomplicated appendectomy, inflammatory bowel disease).
- History or current alcohol abuse or drug addiction
- Subjects who for any reason, are deemed by the Investigator to be inappropriate for this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Open-label Clinical Trial to Evaluate Pharmacokinetic Characteristics and Safety of PBK-1801 After Single Oral Administration in Healthy Korean Women Volunteers
The primary objective of this study is to assess the pharmacokinetic characteristics after a single dose of oral PBK-1801 in healthy Korean women for preparing the bridging data for Koreans.
- Conditions
- Healthy Volunteer
- Being tested
- PBK-1801
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBK-1801Drug
Administered orally
PBK-1801Drug
Administered orally
PBK-1801Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: PBK-1801 |
| B | Experimental | Not described Receives: Drug: PBK-1801 |
| C | Experimental | Not described Receives: Drug: PBK-1801 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: 5 days
AUClast
Measured: 5 days
AUCinf
Measured: 5 days
Tmax
Measured: 5 days
T1/2
Measured: 5 days
CL/F
Measured: 5 days
Vd/F
Measured: 5 days
Secondary outcomes (1)
Number of Participants with Adverse Events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start24 Oct 2019
- Primary completion3 Dec 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmbio Korea Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SeungHwan Lee, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418388
- Sponsor's protocol ID
- PBK_1801_101
- Status last verified
- Jun 2020
- First submitted
- 26 May 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open-label Clinical Trial to Evaluate Pharmacokinetic Characteristics and Safety of PBK-1801 After Single Oral Administration in Healthy Korean Women Volunteers
- ClinicalTrials.gov ID
- NCT04418388
- Acronym / sponsor ID
- PBK_1801_101
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pharmbio Korea Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the pharmacokinetic characteristics after a single dose of oral PBK-1801 in healthy Korean women for preparing the bridging data for Koreans.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: PBK-1801 |
| B | Experimental | Drug: PBK-1801 |
| C | Experimental | Drug: PBK-1801 |
Who may qualify
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Body Mass Index (BMI) between 19 and 30 kg/m²
- Subjects are to be in good general health according to medical history, physical examination, electrocardiograph (ECG) recording and clinical laboratory assessments showing no signs clinically significant pathology (A subject with a clinically insignificant abnormality may be included by the discretion of the investigator)
- Subjects are to have given their written informed consent to participate in the study and to abide by study restrictions
Key exclusion criteria (4 listed)
- History or evidence of clinically significant cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, psychiatric or other major disease
- Subjects who have any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract other than uncomplicated appendectomy, inflammatory bowel disease).
- History or current alcohol abuse or drug addiction
- Subjects who for any reason, are deemed by the Investigator to be inappropriate for this study
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 |
|---|---|---|
| PBK-1801Administered orally | Drug | A |
| PBK-1801Administered orally | Drug | B |
| PBK-1801Administered orally | Drug | C |
Primary outcome
Cmax
Time frame: 5 days
AUClast
Time frame: 5 days
AUCinf
Time frame: 5 days
Tmax
Time frame: 5 days
T1/2
Time frame: 5 days
CL/F
Time frame: 5 days
Vd/F
Time frame: 5 days
1 secondary outcome
Number of Participants with Adverse Events
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
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Screening Protocol
Pain
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.
SeungHwan Lee principal investigator
Seoul National University Hospital
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 PBK-1801 in people with Healthy Volunteer, run by Pharmbio Korea Co., Ltd. at 1 site in South Korea.
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 3 inclusion and 4 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 5 Jun 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 South Korea. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cmax (time frame: 5 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2020.