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The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of RDC-0313 following oral administration.
This is a single-center, randomized, double-blind, ascending dose, placebo controlled study. Dosing sequences will consist of 5 administrations of an oral solution of either ascending doses of RDC-0313 or volume-match placebo. Dosing of cohorts will be staggered to allow a blinded safety review to occur prior to dosing the next cohort. Subjects will be admitted to the facility the morning before each dose, and will be required to fast overnight prior to study drug administration. They will be discharged from the facility after the 36-hour postdose assessments are completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RDC-0313, 5mg | Experimental | 5 mg of RDC-0313; single dose |
|
| RDC-0313, 15 mg | Experimental | 15 mg RDC-0313; single dose |
|
| RDC-0313, 25mg | Experimental | 25 mg RDC-0313; single dose |
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| RDC-0313, 50 mg | Experimental | 50 mg RDC-0313; single dose |
|
| RDC-0313, 75 mg | Experimental | 75 mg RDC-0313; single dose |
|
| Placebo | Placebo Comparator | volume-match placebo; single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RDC-0313 | Drug | Oral solution given in 5, 15, 25, 50, and 75 mg single doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentrations (Cmax) of RDC-0313 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically significant abnormal laboratory findings | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip T. Leese, MD | Quintiles Phase One Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quintiles Phase One Services | Overland Park | Kansas | 66211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25456560 | Derived | Turncliff R, DiPetrillo L, Silverman B, Ehrich E. Single- and multiple-dose pharmacokinetics of samidorphan, a novel opioid antagonist, in healthy volunteers. Clin Ther. 2015 Feb 1;37(2):338-48. doi: 10.1016/j.clinthera.2014.10.001. Epub 2014 Oct 29. |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C583425 | ALKS-33 |
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| Placebo | Drug | Volume matched placebo; oral solution; single dose |
|