Alcohol DependencePhase 1NCT00800319
ALK33-001: A Study of RDC-0313 Administered to Healthy Adults
A Phase 1 study testing RDC-0313 in people with Alcohol Dependence, run by Alkermes, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of RDC-0313 following oral administration. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- RDC-0313
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jun 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Quintiles Phase One Services
Overland Park, Kansas, 66211
About this study
Official title: ALK33-001: A Phase 1 Study of the Pharmacokinetics of RDC-0313 Administered to Healthy Adults
The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of RDC-0313 following oral administration.
Read the 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.
- Conditions
- Alcohol Dependence
- Being tested
- RDC-0313, Placebo
- Keywords
- Alcohol dependence, Opioid antagonist, RDC-0313
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDC-0313Drug
Oral solution given in 5, 15, 25, 50, and 75 mg single doses
PlaceboDrug
Volume matched placebo; oral solution; single dose
| Study group | Role | What they receive |
|---|---|---|
| RDC-0313, 5mg | Experimental | 5 mg of RDC-0313; single dose Receives: Drug: RDC-0313 |
| RDC-0313, 15 mg | Experimental | 15 mg RDC-0313; single dose Receives: Drug: RDC-0313 |
| RDC-0313, 25mg | Experimental | 25 mg RDC-0313; single dose Receives: Drug: RDC-0313 |
| RDC-0313, 50 mg | Experimental | 50 mg RDC-0313; single dose Receives: Drug: RDC-0313 |
| RDC-0313, 75 mg | Experimental | 75 mg RDC-0313; single dose Receives: Drug: RDC-0313 |
| Placebo | Placebo comparator | volume-match placebo; single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentrations (Cmax) of RDC-0313
Measured: 12 weeks
Secondary outcomes (1)
Clinically significant abnormal laboratory findings
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionFeb 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip T. Leese, MD, Principal investigator, Quintiles Phase One Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800319
- Sponsor's protocol ID
- ALK33-001
- Status last verified
- Aug 2011
- First submitted
- 1 Dec 2008
- Last updated
- 22 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25456560
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALK33-001: A Phase 1 Study of the Pharmacokinetics of RDC-0313 Administered to Healthy Adults
- ClinicalTrials.gov ID
- NCT00800319
- Acronym / sponsor ID
- ALK33-001
- Conditions
- Alcohol Dependence
- Keywords
- Alcohol dependence, Opioid antagonist, RDC-0313
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 2 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| RDC-0313, 5mg | Experimental | Drug: RDC-03135 mg of RDC-0313; single dose |
| RDC-0313, 15 mg | Experimental | Drug: RDC-031315 mg RDC-0313; single dose |
| RDC-0313, 25mg | Experimental | Drug: RDC-031325 mg RDC-0313; single dose |
| RDC-0313, 50 mg | Experimental | Drug: RDC-031350 mg RDC-0313; single dose |
| RDC-0313, 75 mg | Experimental | Drug: RDC-031375 mg RDC-0313; single dose |
| Placebo | Placebo comparator | Drug: Placebovolume-match placebo; single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RDC-0313Oral solution given in 5, 15, 25, 50, and 75 mg single doses | Drug | RDC-0313, 15 mg, RDC-0313, 25mg, RDC-0313, 50 mg, RDC-0313, 5mg, RDC-0313, 75 mg |
| PlaceboVolume matched placebo; oral solution; single dose | Drug | Placebo |
Primary outcome
Maximum plasma concentrations (Cmax) of RDC-0313
Time frame: 12 weeks
1 secondary outcome
Clinically significant abnormal laboratory findings
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2011.
- Derived from this study: PubMed 25456560Turncliff 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip T. Leese, MD principal investigator
Quintiles Phase One Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RDC-0313 in people with Alcohol Dependence, run by Alkermes, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentrations (Cmax) of RDC-0313 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00800319, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2011.