Pharmacokinetics of MCS in Healthy Volunteers
MCS-2-US-pk
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
1 other identifier
interventional
12
0 countries
N/A
Brief Summary
This study is to examine the pharmacokinetics, absorption and serum concentrations of MCS and other components after once-daily oral dosing of MCS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Aug 2011
Longer than P75 for phase_1 healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2009
CompletedFirst Posted
Study publicly available on registry
October 28, 2009
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJune 30, 2011
June 1, 2011
1.3 years
October 26, 2009
June 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum MCS and other components levels
21 days
Secondary Outcomes (1)
Incidence of treatment-emergent adverse events
21 days
Study Arms (1)
MCS-2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Normal healthy volunteers
- years of age or older
You may not qualify if:
- Subjects who can not comply with the study procedures or sign the informed consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 26, 2009
First Posted
October 28, 2009
Study Start
August 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
June 30, 2011
Record last verified: 2011-06