Chronic Hepatitis CPhase 1NCT01766167
Clinical Pharmacology Study of MP-424
A Phase 1 study testing MP-424 in people with Chronic Hepatitis C, run by Tanabe Pharma Corporation at 1 site in South Korea.
Trial summary
To conduct the following evaluations in Korean healthy male adult volunteers receiving a single and multiple doses of MP-424 tablets: Pharmacokinetics of MP-424 after a single and multiple doses. Safety and tolerability of single and multiple doses of MP-424. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- MP-424
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2013to Apr 2013
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Korean healthy male volunteers aged 20 to 55 years
Who cannot join
- Subjects with a BMI of <18.5 or >25.0, or body weight of <50kg at prior examination
- Subjects who have had surgery that is known to affect gastrointestinal absorption of drugs (except for appendectomy and hernia surgery)
- Subjects who have had any evidence of cardiac disease at prior examination or who have a previous history of cardiac disease
- Subjects who are positive for HBs antigen, serologic tests for syphilis, HCV antibody, or HIV antibody at prior examination
- Subjects who have experienced symptoms of alcohol abuse or excessive alcohol ingestion
- Subjects who test positive on urinalysis for drug use (amphetamine, benzodiazepine, barbiturates, cannabinoid, cocaine, opiates, and methadone) at prior examination
Show all 10Show fewer
- Subjects who do not agree to use a physical contraceptive method during the study period
- Subjects who do not agree to use contraceptive methods for 90 days after final administration of the study drug
- Subjects who have consumed grapefruit, Seville orange, star fruit, cranberry, or any processed food containing these fruits within 7 days before the commencement of study drug administration
- Subjects who have consumed health foods containing St John's Wort within 2 weeks before study drug administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Pharmacology Study of MP-424 in Healthy Male Adult Volunteers (Single- and Multiple-Dose Study)
To conduct the following evaluations in Korean healthy male adult volunteers receiving a single and multiple doses of MP-424 tablets:
- Pharmacokinetics of MP-424 after a single and multiple doses.
- Safety and tolerability of single and multiple doses of MP-424.
- Conditions
- Chronic Hepatitis C
- Being tested
- MP-424
- Keywords
- Genotype 2
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MP-424Drug
Low
MP-424Drug
Middle
MP-424Drug
High
MP-424Drug
Multiple
| Study group | Role | What they receive |
|---|---|---|
| MP-424 | Experimental | Not described Receives: Drug: MP-424 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MP-424 area under the plasma concentration-time curve (AUC) from 0 to infinity in Korean healthy volunteers
Measured: up to 1 week
Number of participants with adverse events as a measure of safety and tolerability in Korean healthy volunteers
Measured: up to 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kazuoki Kondo, M.D., Study director, Tanabe Pharma Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766167
- Sponsor's protocol ID
- MP-424-K01
- Status last verified
- Apr 2013
- First submitted
- 6 Jan 2013
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pharmacology Study of MP-424 in Healthy Male Adult Volunteers (Single- and Multiple-Dose Study)
- ClinicalTrials.gov ID
- NCT01766167
- Acronym / sponsor ID
- MP-424-K01
- Conditions
- Chronic Hepatitis C
- Keywords
- Genotype 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 11 Jan 2013 (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.
To conduct the following evaluations in Korean healthy male adult volunteers receiving a single and multiple doses of MP-424 tablets:
- Pharmacokinetics of MP-424 after a single and multiple doses.
- Safety and tolerability of single and multiple doses of MP-424.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MP-424 | Experimental | Drug: MP-424 |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Korean healthy male volunteers aged 20 to 55 years
Key exclusion criteria (10 listed)
- Subjects with a BMI of <18.5 or >25.0, or body weight of <50kg at prior examination
- Subjects who have had surgery that is known to affect gastrointestinal absorption of drugs (except for appendectomy and hernia surgery)
- Subjects who have had any evidence of cardiac disease at prior examination or who have a previous history of cardiac disease
- Subjects who are positive for HBs antigen, serologic tests for syphilis, HCV antibody, or HIV antibody at prior examination
- Subjects who have experienced symptoms of alcohol abuse or excessive alcohol ingestion
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 |
|---|---|---|
| MP-424Low | Drug | MP-424 |
| MP-424Middle | Drug | MP-424 |
| MP-424High | Drug | MP-424 |
| MP-424Multiple | Drug | MP-424 |
Primary outcome
MP-424 area under the plasma concentration-time curve (AUC) from 0 to infinity in Korean healthy volunteers
Time frame: up to 1 week
Number of participants with adverse events as a measure of safety and tolerability in Korean healthy volunteers
Time frame: up to 2 week
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 26 Jan 2017.
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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.
Kazuoki Kondo, M.D. study director
Tanabe Pharma Corporation
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 MP-424 in people with Chronic Hepatitis C, run by Tanabe Pharma Corporation 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 1 inclusion and 10 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 26 Jan 2017. 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?
MP-424 area under the plasma concentration-time curve (AUC) from 0 to infinity in Korean healthy volunteers (time frame: up to 1 week). 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 26 Jan 2017.