ArthritisPhase 1NCT03553316
Drug-Drug Interaction Between PK101-001 and PK101-002
A Phase 1 study testing PK101-002 and PK101 in people with Arthritis, run by PMG Pharm Co., Ltd at 1 site in South Korea.
Trial summary
To evaluate the drug-drug interaction of PK101-001 and PK101-002 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthritis
- What is being tested?
- PK101-002 and PK101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Feb 2019to 24 Apr 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults ≥ 19 years of age (on the day of screening)
- No congenital or chronic diseases and no abnormal signs determined by medical examinations
- Not abnormal or not clinical significant lab values
- 90mmHg ≤ (SBP) ≤ 139mmHg, 60mmHg ≤ (DBP) ≤ 89mmHg
- 18Kg/(m)^2 ≤ (BMI) ≤30Kg/(m)^2
Who cannot join
- Subjects who were administered below medications within 30 days (barbiturates, drugs of induced or suppressive drug metabolizing enzyme, etc)
- Subjects who were administered medications of prohibition within 10 days
- Heavy drinking within 30 days (female: over 14units/week, male:over 21units/week)
- Heavy smoker within 30 days (over 20 cigarettes per day)
- Subjects who previously participated in other clinical trials or bioequivalence Test within 90 days
- Subjects who donated whole blood within 60 days or donated component blood within 14 days or received blood transfusion within 30 days
- Subjects who have hypersensitivity for investigational products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Labeled, Multiple Dose, 2-Sequence, 2-Period Cross-over Phase 1 Study to Evaluate the Drug-Drug Interaction of PK101-001 and PK101-002 in Healthy Volunteers.
To evaluate the drug-drug interaction of PK101-001 and PK101-002 in healthy volunteers.
- Conditions
- Arthritis
- Being tested
- PK101-002, PK101
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PK101-002Drug
Also called A
-(Single) PK101-002
PK101Combination product
Also called B
-(Combination) PK101-001, PK101-002
| Study group | Role | What they receive |
|---|---|---|
| Sequence (1) | Experimental | Number of Subject: 24
Wash out Period: over 7 days (between each period)
Investigators Products(IPs) for Period1: A (Single)= PK101-002
IPs for Period2: B (Combination)= PK101-001, PK101-002 Receives: Drug: PK101-002; Combination Product: PK101 |
| Sequence (2) | Experimental | Number of Subject: 24
Wash out Period: over 7 days (between each period)
IPs for Period1: B (Combination)= PK101-001, PK101-002
IPs for Period2: A (Single)= PK101-002 Receives: Drug: PK101-002; Combination Product: PK101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ
Area under the plasma drug concentration-time curve for PK101-002 at Steady-state (between dose times)
Measured: 0, 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
Cmax,ss
The maximum (or peak) serum concentration for PK101-002 at Steady-state
Measured: 0, 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start28 Feb 2019
- Primary completion22 Mar 2019
- Study completion24 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- PMG Pharm Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seung-Hyun Kang, Principal investigator, H Plus Yangji Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553316
- Sponsor's protocol ID
- PK101_P101
- Status last verified
- Aug 2018
- First submitted
- 27 May 2018
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Labeled, Multiple Dose, 2-Sequence, 2-Period Cross-over Phase 1 Study to Evaluate the Drug-Drug Interaction of PK101-001 and PK101-002 in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT03553316
- Acronym / sponsor ID
- PK101_P101
- Conditions
- Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- PMG Pharm Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 24 Apr 2019 (actual)
- First posted
- 12 Jun 2018 (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.
To evaluate the drug-drug interaction of PK101-001 and PK101-002 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence (1) | Experimental | Drug: PK101-002, Combination Product: PK101Number of Subject: 24 Wash out Period: over 7 days (between each period) Investigators Products(IPs) for Period1: A (Single)= PK101-002 IPs for Period2: B (Combination)= PK101-001, PK101-002 |
| Sequence (2) | Experimental | Drug: PK101-002, Combination Product: PK101Number of Subject: 24 Wash out Period: over 7 days (between each period) IPs for Period1: B (Combination)= PK101-001, PK101-002 IPs for Period2: A (Single)= PK101-002 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy adults ≥ 19 years of age (on the day of screening)
- No congenital or chronic diseases and no abnormal signs determined by medical examinations
- Not abnormal or not clinical significant lab values
- 90mmHg ≤ (SBP) ≤ 139mmHg, 60mmHg ≤ (DBP) ≤ 89mmHg
- 18Kg/(m)^2 ≤ (BMI) ≤30Kg/(m)^2
Key exclusion criteria (7 listed)
- Subjects who were administered below medications within 30 days (barbiturates, drugs of induced or suppressive drug metabolizing enzyme, etc)
- Subjects who were administered medications of prohibition within 10 days
- Heavy drinking within 30 days (female: over 14units/week, male:over 21units/week)
- Heavy smoker within 30 days (over 20 cigarettes per day)
- Subjects who previously participated in other clinical trials or bioequivalence Test within 90 days
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 |
|---|---|---|
| PK101-002Also: A-(Single) PK101-002 | Drug | Sequence (1), Sequence (2) |
| PK101Also: B-(Combination) PK101-001, PK101-002 | Combination product | Sequence (1), Sequence (2) |
Primary outcome
AUCτ
Time frame: 0, 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
Area under the plasma drug concentration-time curve for PK101-002 at Steady-state (between dose times)
Cmax,ss
Time frame: 0, 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
The maximum (or peak) serum concentration for PK101-002 at Steady-state
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 24 May 2019.
- Individual participant dataSharing planned: No
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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.
Seung-Hyun Kang principal investigator
H Plus Yangji Clinical Research Center
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 PK101-002 and PK101 in people with Arthritis, run by PMG Pharm 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 5 inclusion and 7 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 24 May 2019. 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?
AUCτ (time frame: 0, 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour). The study lists 2 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 24 May 2019.