Back to resultsALK33-001: A Study of RDC-0313 Administered to Healthy Adults
Primary Purpose
Alcohol Dependence
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RDC-0313
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol dependence, Opioid antagonist, RDC-0313
Eligibility Criteria
Inclusion Criteria:
- 18 - 65 years of age
- Body mass index of 19-30 kg/m2 at screening
- If subject is female and of childbearing potential, she must agree to use an acceptable method of contraception
- If subject is male, he must agree to reduce the risk of a female partner becoming pregnant
Exclusion Criteria:
- Pregnancy and/or currently breastfeeding
- Clinically significant medical condition or observed abnormalities
- Clinically significant illness within 30 days of the first study drug administration
- History of opioid dependence
- Positive urine toxicological screen for marijuana, cocaine, amphetamines, opioids, barbiturates, and benzodiazepines
- Positive resolut for any serology test performed at screening
- Use of alcohol-, caffeine-, or xanthine-containing products
- Tobacco use within 90 days before the first study drug administration
- Participation in a clinical trial within 30 days before screening
- Requirement of a special diet other than vegetarian, or significant food allergy or intolerance
Sites / Locations
- Quintiles Phase One Services
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
RDC-0313, 5mg
RDC-0313, 15 mg
RDC-0313, 25mg
RDC-0313, 50 mg
RDC-0313, 75 mg
Placebo
Arm Description
5 mg of RDC-0313; single dose
15 mg RDC-0313; single dose
25 mg RDC-0313; single dose
50 mg RDC-0313; single dose
75 mg RDC-0313; single dose
volume-match placebo; single dose
Outcomes
Primary Outcome Measures
Maximum plasma concentrations (Cmax) of RDC-0313
Secondary Outcome Measures
Clinically significant abnormal laboratory findings
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00800319
Brief Title
ALK33-001: A Study of RDC-0313 Administered to Healthy Adults
Official Title
ALK33-001: A Phase 1 Study of the Pharmacokinetics of RDC-0313 Administered to Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alkermes, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of RDC-0313 following oral administration.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Alcohol dependence, Opioid antagonist, RDC-0313
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RDC-0313, 5mg
Arm Type
Experimental
Arm Description
5 mg of RDC-0313; single dose
Arm Title
RDC-0313, 15 mg
Arm Type
Experimental
Arm Description
15 mg RDC-0313; single dose
Arm Title
RDC-0313, 25mg
Arm Type
Experimental
Arm Description
25 mg RDC-0313; single dose
Arm Title
RDC-0313, 50 mg
Arm Type
Experimental
Arm Description
50 mg RDC-0313; single dose
Arm Title
RDC-0313, 75 mg
Arm Type
Experimental
Arm Description
75 mg RDC-0313; single dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
volume-match placebo; single dose
Intervention Type
Drug
Intervention Name(s)
RDC-0313
Intervention Description
Oral solution given in 5, 15, 25, 50, and 75 mg single doses
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Volume matched placebo; oral solution; single dose
Primary Outcome Measure Information:
Title
Maximum plasma concentrations (Cmax) of RDC-0313
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Clinically significant abnormal laboratory findings
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 - 65 years of age
Body mass index of 19-30 kg/m2 at screening
If subject is female and of childbearing potential, she must agree to use an acceptable method of contraception
If subject is male, he must agree to reduce the risk of a female partner becoming pregnant
Exclusion Criteria:
Pregnancy and/or currently breastfeeding
Clinically significant medical condition or observed abnormalities
Clinically significant illness within 30 days of the first study drug administration
History of opioid dependence
Positive urine toxicological screen for marijuana, cocaine, amphetamines, opioids, barbiturates, and benzodiazepines
Positive resolut for any serology test performed at screening
Use of alcohol-, caffeine-, or xanthine-containing products
Tobacco use within 90 days before the first study drug administration
Participation in a clinical trial within 30 days before screening
Requirement of a special diet other than vegetarian, or significant food allergy or intolerance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip T. Leese, MD
Organizational Affiliation
Quintiles Phase One Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quintiles Phase One Services
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25456560
Citation
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.
Results Reference
derived
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ALK33-001: A Study of RDC-0313 Administered to Healthy Adults
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