ALK33-001: A Study of RDC-0313 Administered to Healthy Adults
ALK33-001: A Phase 1 Study of the Pharmacokinetics of RDC-0313 Administered to Healthy Adults
1 other identifier
interventional
16
1 country
1
Brief Summary
The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of RDC-0313 following oral administration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2008
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedFirst Posted
Study publicly available on registry
December 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedAugust 22, 2011
August 1, 2011
2 months
December 1, 2008
August 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum plasma concentrations (Cmax) of RDC-0313
12 weeks
Secondary Outcomes (1)
Clinically significant abnormal laboratory findings
12 weeks
Study Arms (6)
RDC-0313, 5mg
EXPERIMENTAL5 mg of RDC-0313; single dose
RDC-0313, 15 mg
EXPERIMENTAL15 mg RDC-0313; single dose
RDC-0313, 25mg
EXPERIMENTAL25 mg RDC-0313; single dose
RDC-0313, 50 mg
EXPERIMENTAL50 mg RDC-0313; single dose
RDC-0313, 75 mg
EXPERIMENTAL75 mg RDC-0313; single dose
Placebo
PLACEBO COMPARATORvolume-match placebo; single dose
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alkermes, Inc.lead
Study Sites (1)
Quintiles Phase One Services
Overland Park, Kansas, 66211, United States
Related Publications (1)
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.
PMID: 25456560DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip T. Leese, MD
Quintiles Phase One Services
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2008
First Posted
December 2, 2008
Study Start
December 1, 2008
Primary Completion
February 1, 2009
Study Completion
June 1, 2009
Last Updated
August 22, 2011
Record last verified: 2011-08