HealthyPhase 1NCT02554136
Evaluating a Pharmacokinetic Drug Interaction Between HGP0918 and HGP0816
A Phase 1 study testing HGP0918, HGP0816 and HGP0918 + HGP0816 in people with Healthy, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
The investigators investigate the potential pharmacokinetic drug-drug interaction between HGP0918 and HGP0816 in healthy adult subjects who receive HGP0918 alone, HGP0816 alone, and both together in a 3 period repeatedly Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HGP0918, HGP0816 and HGP0918 + HGP0816
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2015to Aug 2015
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
- Healthy male volunteers, aged 19 to 55 years.
- The result of Body Mass Index(BMI) is not less than 18.5 kg/m2 , no more than 27.0 kg/m2
Who cannot join
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- Someone has a declined liver function and Liver enzyme (AST, ALT or total bilirubin) level exceeds more than one and a half times normal upper range
- Somenone has a declined kidney function and his eGFR < 60mL/min/1.73m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-labeled, Randomized Crossover Study to Evaluate the Pharmacokinetic Interaction and Safety After Single Oral Administration of HGP0918 and HGP0816 in Healthy Adult Subjects
The investigators investigate the potential pharmacokinetic drug-drug interaction between HGP0918 and HGP0816 in healthy adult subjects who receive HGP0918 alone, HGP0816 alone, and both together in a 3 period repeatedly
- Conditions
- Healthy
- Being tested
- HGP0918, HGP0816, HGP0918 + HGP0816
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HGP0918Drug
HGP0816Drug
HGP0918 + HGP0816Drug
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | HGP0918 -> HGP0816 -> HGP0918 + HGP0816 Receives: Drug: HGP0918; Drug: HGP0816; Drug: HGP0918 + HGP0816 |
| Sequence 2 | Experimental | HGP0816 -> HGP0918 + HGP0816 -> HGP0918 Receives: Drug: HGP0918; Drug: HGP0816; Drug: HGP0918 + HGP0816 |
| Sequence 3 | Experimental | HGP0918 + HGP0816 -> HGP0918 -> HGP0816 Receives: Drug: HGP0918; Drug: HGP0816; Drug: HGP0918 + HGP0816 |
| Sequence 4 | Experimental | HGP0918 -> HGP0918 + HGP0816 -> HGP0816 Receives: Drug: HGP0918; Drug: HGP0816; Drug: HGP0918 + HGP0816 |
| Sequence 5 | Experimental | HGP0816 -> HGP0918 -> HGP0918 + HGP0816 Receives: Drug: HGP0918; Drug: HGP0816; Drug: HGP0918 + HGP0816 |
| Sequence 6 | Experimental | HGP0918 + HGP0816 -> HGP0816 -> HGP0918 Receives: Drug: HGP0918; Drug: HGP0816; Drug: HGP0918 + HGP0816 |
What is being measured
The primary outcome is the main question the study is designed to answer.
baseline-corrected Cmax of HGP0918
Measured: -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
baseline-corrected AUCt of HGP0918
Measured: -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
Cmax of HGP0816
Measured: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
AUCt of HGP0816
Measured: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
Secondary outcomes (9)
Cmax of HGP0918
Measured: -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
AUCt of HGP0918
Measured: -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
Tmax of HGP0918
Measured: -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
t1/2β of HGP0918
Measured: -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
AUC∞ of HGP0816
Measured: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
Tmax of HGP0816
Measured: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
t1/2β of HGP0816
Measured: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
CL/F of HGP0816
Measured: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
Vdz/F of HGP0816
Measured: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554136
- Sponsor's protocol ID
- HM-ROMA-105
- Status last verified
- Sep 2015
- First submitted
- 17 Sep 2015
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-labeled, Randomized Crossover Study to Evaluate the Pharmacokinetic Interaction and Safety After Single Oral Administration of HGP0918 and HGP0816 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02554136
- Acronym / sponsor ID
- HM-ROMA-105
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 18 Sep 2015 (estimated)
- 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 investigators investigate the potential pharmacokinetic drug-drug interaction between HGP0918 and HGP0816 in healthy adult subjects who receive HGP0918 alone, HGP0816 alone, and both together in a 3 period repeatedly
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: HGP0918, Drug: HGP0816, Drug: HGP0918 + HGP0816HGP0918 -> HGP0816 -> HGP0918 + HGP0816 |
| Sequence 2 | Experimental | Drug: HGP0918, Drug: HGP0816, Drug: HGP0918 + HGP0816HGP0816 -> HGP0918 + HGP0816 -> HGP0918 |
| Sequence 3 | Experimental | Drug: HGP0918, Drug: HGP0816, Drug: HGP0918 + HGP0816HGP0918 + HGP0816 -> HGP0918 -> HGP0816 |
| Sequence 4 | Experimental | Drug: HGP0918, Drug: HGP0816, Drug: HGP0918 + HGP0816HGP0918 -> HGP0918 + HGP0816 -> HGP0816 |
| Sequence 5 | Experimental | Drug: HGP0918, Drug: HGP0816, Drug: HGP0918 + HGP0816HGP0816 -> HGP0918 -> HGP0918 + HGP0816 |
| Sequence 6 | Experimental | Drug: HGP0918, Drug: HGP0816, Drug: HGP0918 + HGP0816HGP0918 + HGP0816 -> HGP0816 -> HGP0918 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
- Healthy male volunteers, aged 19 to 55 years.
- The result of Body Mass Index(BMI) is not less than 18.5 kg/m2 , no more than 27.0 kg/m2
Key exclusion criteria (3 listed)
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- Someone has a declined liver function and Liver enzyme (AST, ALT or total bilirubin) level exceeds more than one and a half times normal upper range
- Somenone has a declined kidney function and his eGFR < 60mL/min/1.73m2
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 |
|---|---|---|
| HGP0918 | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| HGP0816 | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| HGP0918 + HGP0816 | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
baseline-corrected Cmax of HGP0918
Time frame: -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
baseline-corrected AUCt of HGP0918
Time frame: -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
Cmax of HGP0816
Time frame: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
AUCt of HGP0816
Time frame: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
9 secondary outcomes
Cmax of HGP0918
Time frame: -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
AUCt of HGP0918
Time frame: -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
Tmax of HGP0918
Time frame: -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
t1/2β of HGP0918
Time frame: -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)
AUC∞ of HGP0816
Time frame: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
Tmax of HGP0816
Time frame: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
t1/2β of HGP0816
Time frame: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
CL/F of HGP0816
Time frame: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
Vdz/F of HGP0816
Time frame: 0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)
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 18 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 HGP0918, HGP0816 and HGP0918 + HGP0816 in people with Healthy, run by Hanmi Pharmaceutical Company Limited 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 3 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 18 Sep 2015. 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?
baseline-corrected Cmax of HGP0918 (time frame: -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)). The study lists 4 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 18 Sep 2015.