HealthyPhase 1PGP inhibitorNCT00954304
Duration of P-glycoprotein Inhibition After Oral Administration of HM30181AK Tablet
A Phase 1 study testing HM30181AK 1mg, HM30181AK 5mg and HM30181AK 15mg in people with Healthy, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
The purposes of this study are to investigate the duration of P-glycoprotein inhibition after oral administration of HM30181AK tablet in healthy male subject and proper dose of HM30181AK tablet. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HM30181AK 1mg, HM30181AK 5mg and HM30181AK 15mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2009to Sep 2009
- 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers aged 20 to 50 years at screening
- Subjects whose weights are heavier than or equal to 50 kg and ±20% of ideal body weight
- Ideal body weight = (height cm - 100) x 0.9
- Subjects who provided written, voluntary informed consent to participate in this clinical trial and to comply the directions including contraception after being fully informed of and understand this trial
Who cannot join
- Subjects who have the clinically significant diseases or history in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor and cardiovascular system.
- History of the gastrointestinal diseases which may affect the absorption of oral drugs (e.g., Crohn's disease) or gastrointestinal operations (excluding simple typhlotomy and hernia repair).
- The following results in laboratory test
- AST, ALT > 1.25 x upper limits of normal
- Systolic blood pressure below 100 mmHg or above 150 mmHg or diastolic blood pressure below 65 mmHg or above 95 mmHg in vital signs
- History of drug allergy or other allergies which are clinically significant
Show all 14Show fewer
- History of drug abuse or positive reaction for drug abuse in urine screening test
- Subjects who took prescription drugs or herbal medicines within 2 weeks prior to the first day of drug administration or OTC or vitamin preparations within 1 week prior to the first day of drug administration If the subjects meet other criteria, they could participate in the trial in the judgement of investigator.)
- Subjects who have participated in other clinical trial within 2 months prior to the first day of drug administration
- Whole blood donation within 2 months prior to the first day of drug administration or apheresis donation within 2 weeks prior to the first day of drug administration
- Subject who are continuously drinking alcohol (over 21 units/week) or who cannot quit drinking during clinical trial period
- Subject who are smoking over 10 cigar/day
- Subjects who eat food containing caffeine or grapefruit or drink alcohol in prohibited period
- Subjects who are inappropriate in the judgement of the investigator due to the reasons including clinical laboratory test results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial to Investigate the Duration of P-glycoprotein Inhibition After Oral Administration of HM30181AK Tablet in Healthy Male Subjects : An Open, Parallel Dose Group Design
The purposes of this study are to investigate the duration of P-glycoprotein inhibition after oral administration of HM30181AK tablet in healthy male subject and proper dose of HM30181AK tablet.
- Conditions
- Healthy
- Being tested
- HM30181AK 1mg, HM30181AK 5mg, HM30181AK 15mg, HM30181AK 60mg, Loperamide 2mg
- Keywords
- Pgp inhibitor, P-glycoprotein inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM30181AK 1mgDrug
HM30181AK 1mg tablet
HM30181AK 5mgDrug
HM30181AK 5mg tablet
HM30181AK 15mgDrug
HM30181AK 15mg tablet
HM30181AK 60mgDrug
HM30181AK 60mg tablet
Loperamide 2mgDrug
Loperamide 2mg capsule
| Study group | Role | What they receive |
|---|---|---|
| 1mg group | Experimental | Administration of HM30181AK 1mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15 Receives: Drug: HM30181AK 1mg; Drug: Loperamide 2mg |
| 5mg group | Experimental | Administration of HM30181AK 5mg on day 4 and Loperamide 16mg(Loperamide 2mg x 8cap) on day 1,4,8,11,15 Receives: Drug: HM30181AK 5mg; Drug: Loperamide 2mg |
| 10mg group | Experimental | Administration of HM30181AK 10mg(HM30181AK 5mg x 2tab)on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15 Receives: Drug: HM30181AK 5mg; Drug: Loperamide 2mg |
| 15mg group | Experimental | Administration of HM30181AK 15mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15 Receives: Drug: HM30181AK 15mg; Drug: Loperamide 2mg |
| 60mg group | Experimental | Administration of HM30181AK 60mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15 Receives: Drug: HM30181AK 60mg; Drug: Loperamide 2mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the duration of P-glycoprotein inhibition of HM30181AK by the Loperamide AUC measurement.
Measured: Day 1~Day 18
Secondary outcomes (1)
Evaluate the PK parameters (Cmax, AUClast, AUCinf, Tmax, T1/2, CL/F etc) of HM30181AK by measuring the blood concentration of HM30181AK
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2009
- Study completionSep 2009
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kyung-Sang Yu, MD., Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954304
- Sponsor's protocol ID
- HM-OXL-104
- Acronym
- PGP inhibitor
- Status last verified
- Sep 2010
- First submitted
- 6 Aug 2009
- Last updated
- 13 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Investigate the Duration of P-glycoprotein Inhibition After Oral Administration of HM30181AK Tablet in Healthy Male Subjects : An Open, Parallel Dose Group Design
- ClinicalTrials.gov ID
- NCT00954304
- Acronym / sponsor ID
- PGP inhibitor / HM-OXL-104
- Conditions
- Healthy
- Keywords
- Pgp inhibitor, P-glycoprotein inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 7 Aug 2009 (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 purposes of this study are to investigate the duration of P-glycoprotein inhibition after oral administration of HM30181AK tablet in healthy male subject and proper dose of HM30181AK tablet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1mg group | Experimental | Drug: HM30181AK 1mg, Drug: Loperamide 2mgAdministration of HM30181AK 1mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15 |
| 5mg group | Experimental | Drug: HM30181AK 5mg, Drug: Loperamide 2mgAdministration of HM30181AK 5mg on day 4 and Loperamide 16mg(Loperamide 2mg x 8cap) on day 1,4,8,11,15 |
| 10mg group | Experimental | Drug: HM30181AK 5mg, Drug: Loperamide 2mgAdministration of HM30181AK 10mg(HM30181AK 5mg x 2tab)on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15 |
| 15mg group | Experimental | Drug: HM30181AK 15mg, Drug: Loperamide 2mgAdministration of HM30181AK 15mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15 |
| 60mg group | Experimental | Drug: HM30181AK 60mg, Drug: Loperamide 2mgAdministration of HM30181AK 60mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male volunteers aged 20 to 50 years at screening
- Subjects whose weights are heavier than or equal to 50 kg and ±20% of ideal body weight
- Subjects who provided written, voluntary informed consent to participate in this clinical trial and to comply the directions including contraception after being fully informed of and understand this trial
Key exclusion criteria (14 listed)
- Subjects who have the clinically significant diseases or history in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor and cardiovascular system.
- History of the gastrointestinal diseases which may affect the absorption of oral drugs (e.g., Crohn's disease) or gastrointestinal operations (excluding simple typhlotomy and hernia repair).
- The following results in laboratory test
- Systolic blood pressure below 100 mmHg or above 150 mmHg or diastolic blood pressure below 65 mmHg or above 95 mmHg in vital signs
- History of drug allergy or other allergies which are clinically significant
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 |
|---|---|---|
| HM30181AK 1mgHM30181AK 1mg tablet | Drug | 1mg group |
| HM30181AK 5mgHM30181AK 5mg tablet | Drug | 10mg group, 5mg group |
| HM30181AK 15mgHM30181AK 15mg tablet | Drug | 15mg group |
| HM30181AK 60mgHM30181AK 60mg tablet | Drug | 60mg group |
| Loperamide 2mgLoperamide 2mg capsule | Drug | 10mg group, 15mg group, 1mg group, 5mg group, 60mg group |
Primary outcome
Evaluate the duration of P-glycoprotein inhibition of HM30181AK by the Loperamide AUC measurement.
Time frame: Day 1~Day 18
1 secondary outcome
Evaluate the PK parameters (Cmax, AUClast, AUCinf, Tmax, T1/2, CL/F etc) of HM30181AK by measuring the blood concentration of HM30181AK
Time frame: Day 4
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 13 Sep 2010.
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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.
Kyung-Sang Yu, MD., Ph.D 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 HM30181AK 1mg, HM30181AK 5mg and HM30181AK 15mg 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 4 inclusion and 14 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 Sep 2010. 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?
Evaluate the duration of P-glycoprotein inhibition of HM30181AK by the Loperamide AUC measurement. (time frame: Day 1~Day 18). 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 13 Sep 2010.