Phase 1 Study to Evaluate RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01046539
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : January 11, 2017
Alkermes, Inc.
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
This is a single site, double-blind, randomized, placebo-controlled, crossover study to assess the pharmacodynamics (PD) of RDC-0313 coadministered with buprenorphine in 12 healthy, opioid-experienced, non-treatment-seeking subjects.

Condition or disease Intervention/treatment Phase
Substance-Related Disorders Drug: RDC-0313 + Buprenorphine Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Evaluate the Pharmacodynamics of RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy Adults
Study Start Date : January 2010
Actual Primary Completion Date : March 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: RDC-0313 + Buprenorphine
Cohort 1 (1 and 4 mg) + 8 mg Cohort 2 (dependent on Cohort 1 results)
Drug: RDC-0313 + Buprenorphine
1 and 4 mg (1 dose for each) + 8 mg
Placebo Comparator: Placebo Drug: Placebo
0 mg

Primary Outcome Measures :
  1. Pharmacodynamics (PD) of study drug [ Time Frame: 24 hour period ]
  2. VAS Scores [ Time Frame: 24 Hours period ]
  3. Pupuillometry Assessments [ Time Frame: 24 Hour Period ]
  4. Subjective Symptoms [ Time Frame: 15 min pre and post nal, 3 hrs post bup admin ]

Secondary Outcome Measures :
  1. To determine pharmacokinetics (PK) and evaluate safety and tolerability of study drug [ Time Frame: 24 hour period ]
  2. Max plasma concentration [ Time Frame: 24 Hour Period ]
  3. Time to maximum plasma concentration [ Time Frame: 24 Hour Period ]
  4. Area under the concentration time curve (AUC) [ Time Frame: 24 Hour Period ]
  5. Additional PK parameters may be analyzed [ Time Frame: As appropriate ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject must be capable of understanding and complying with the protocol and has signed the informed consent
  • Must be 18-55 years of age
  • Must have a body mass index of 18.0-30.0 kg/m2 at screening
  • Female subjects must agree to use an acceptable method of contraception from date of consent and until two weeks after the last dose
  • Subjects must be willing not to use alcohol-, tobacco, caffeine-, or xanthine-containing products while resident at inpatient facility
  • Subjects must be an experienced opioid user who meets the following criteria: 1) has used opioids for non-therapeutic purposes (ie, for psychoactive effects) on at least 10 occasions in the past five years; 2) has used opioids at least 2 times in the two years prior to screening; and 3) is not physically dependent on opioids, as assessed by medical history and naloxone challenge performed at screening

Exclusion Criteria:

  • Must not have any current or piror significant hepatic, renal, endocrine, cardiac, nervous, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorders.
  • Must not have current or past opioid, alcohol, or other durg dependence (excluding nicotine and caffeine) or showing signs of withdrawal following the naloxone (Narcan) challenge.
  • Please contact site for additional information about other exclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01046539

United States, California
Langley Porter Psychiatric Hospital
San Francisco, California, United States, 94143
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Alkermes, Inc.

Responsible Party: Reese Jones, M.D. / Principal Investigator, Langley Porter Psychiatric Hospital Identifier: NCT01046539     History of Changes
Other Study ID Numbers: ALK33-008
First Posted: January 12, 2010    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: July 2010

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists