HealthyPhase 1MCS-2-US-pkNCT01003171
Pharmacokinetics of MCS in Healthy Volunteers
A Phase 1 study testing MCS-2 soft-gel capsule in people with Healthy, run by Health Ever Bio-Tech Co., Ltd..
Trial summary
This study is to examine the pharmacokinetics, absorption and serum concentrations of MCS and other components after once-daily oral dosing of MCS. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MCS-2 soft-gel capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Dec 2012
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal healthy volunteers
- 18 years of age or older
Who cannot join
- Subjects who can not comply with the study procedures or sign the informed consent form
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Open-Label, Multiple-Dose Study of MCS-2 to Examine the Pharmacokinetics of MCS and Other Components After Once-daily Oral Dosing in Healthy Adult Volunteers
This study is to examine the pharmacokinetics, absorption and serum concentrations of MCS and other components after once-daily oral dosing of MCS.
Read the detailed description
This study is an open-label, multiple-dose study, whose objective is to examine the pharmacokinetics of MCS and other components after once-daily oral dosing for 21 days.
Subjects will undergo a 14-day washout phase and then enter the 21-day treatment phase. During the treatment phase, subjects will receive MCS, once-daily within one hour after the evening meal. After completion of the treatment phase, subjects will enter a post-treatment 42-day washout phase. Throughout each of these phases, blood samples will be collected and assayed for concentrations of MCS and other components. The duration of protocol participation is expected to be 77 days for each eligible subject who completes the study.
- Conditions
- Healthy
- Being tested
- MCS-2 soft-gel capsule
- Keywords
- Pharmacokinetics, PK, MCS, Benign Prostatic Hyperplasia, Multi-Carotenoids, Healthy subjects
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCS-2 soft-gel capsuleDrug
Also called MUS
MCS-2 30 mg/day
| Study group | Role | What they receive |
|---|---|---|
| MCS-2 | Experimental | Not described Receives: Drug: MCS-2 soft-gel capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum MCS and other components levels
Measured: 21 days
Secondary outcomes (1)
Incidence of treatment-emergent adverse events
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startAug 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health Ever Bio-Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003171
- Sponsor's protocol ID
- MCS-2-US-pk
- Acronym
- MCS-2-US-pk
- Status last verified
- Jun 2011
- First submitted
- 26 Oct 2009
- Last updated
- 30 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multiple-Dose Study of MCS-2 to Examine the Pharmacokinetics of MCS and Other Components After Once-daily Oral Dosing in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01003171
- Acronym / sponsor ID
- MCS-2-US-pk / MCS-2-US-pk
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, PK, MCS, Benign Prostatic Hyperplasia, Multi-Carotenoids, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Health Ever Bio-Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 28 Oct 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.
This study is to examine the pharmacokinetics, absorption and serum concentrations of MCS and other components after once-daily oral dosing of MCS.
Detailed description
This study is an open-label, multiple-dose study, whose objective is to examine the pharmacokinetics of MCS and other components after once-daily oral dosing for 21 days.
Subjects will undergo a 14-day washout phase and then enter the 21-day treatment phase. During the treatment phase, subjects will receive MCS, once-daily within one hour after the evening meal. After completion of the treatment phase, subjects will enter a post-treatment 42-day washout phase. Throughout each of these phases, blood samples will be collected and assayed for concentrations of MCS and other components. The duration of protocol participation is expected to be 77 days for each eligible subject who completes the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MCS-2 | Experimental | Drug: MCS-2 soft-gel capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Normal healthy volunteers
- 18 years of age or older
Key exclusion criteria (1 listed)
- Subjects who can not comply with the study procedures or sign the informed consent form
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 |
|---|---|---|
| MCS-2 soft-gel capsuleAlso: MUSMCS-2 30 mg/day | Drug | MCS-2 |
Primary outcome
Serum MCS and other components levels
Time frame: 21 days
1 secondary outcome
Incidence of treatment-emergent adverse events
Time frame: 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2011.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MCS-2 soft-gel capsule in people with Healthy, run by Health Ever Bio-Tech Co., Ltd..
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fu-Feng Kuo (+886-2-25788621, Healthe@ms76.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum MCS and other components levels (time frame: 21 days). 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 30 Jun 2011.