The purpose of this study is to assess the safety and tolerability of RDC-1036 (ALKS 37) in adults with opioid-induced constipation (OIC) following repeat dose administration
Approximately 60 subjects will be enrolled in 1 of 2 cohorts. Following a review of Cohort 1 safety and tolerability data, subjects will then be enrolled into Cohort 2, to explore additional doses. Dose escalation will occur in both cohorts. There will be 18 visits over a 6-week period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Capsules for oral administration
Capsules for oral administration
Alkermes Investigational Site
Sheffield, Alabama, United States
Alkermes Investigational Site
Anaheim, California, United States
Alkermes Investigational Site
Pasadena, California, United States
Change in frequency of spontaneous bowel movement (SBM) from pre-treatment period to treatment period
Time frame: 4 Weeks
Number of subjects reporting treatment-emergent adverse events (TEAEs)
A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).
Time frame: 6 Weeks
Change in rescue laxative use from pre-treatment to treatment period
Time frame: 4 Weeks
Study drug dose prior to first SBM after randomization
Time frame: 4 weeks
Scores to study-related questionnaires
Time frame: 6 weeks
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Alkermes Investigational Site
Walnut Creek, California, United States
Alkermes Investigational Site
DeLand, Florida, United States
Alkermes Investigative Site
New Smyrna Beach, Florida, United States
Alkermes Investigational Site
Boise, Idaho, United States
Alkermes Investigational Site
New Orleans, Louisiana, United States
Alkermes Investigational Site
Winston-Salem, North Carolina, United States
Alkermes Investigational Site
Dayton, Ohio, United States
...and 1 more locations