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

NCT01046539 | Completed Phase 1

• 1 other identifier: ALK33-008
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance-Related Disorders

Outcome Measures

Primary Outcomes (4)

• Pharmacodynamics (PD) of study drug

  24 hour period

• VAS Scores

  24 Hours period

• Pupuillometry Assessments

  24 Hour Period

• Subjective Symptoms

  15 min pre and post nal, 3 hrs post bup admin

Secondary Outcomes (5)

• To determine pharmacokinetics (PK) and evaluate safety and tolerability of study drug

  24 hour period

• Max plasma concentration

  24 Hour Period

• Time to maximum plasma concentration

  24 Hour Period

• Area under the concentration time curve (AUC)

  24 Hour Period

• Additional PK parameters may be analyzed

  As appropriate

Study Arms (2)

RDC-0313 + Buprenorphine

ACTIVE COMPARATOR

Cohort 1 (1 and 4 mg) + 8 mg Cohort 2 (dependent on Cohort 1 results)

Drug: RDC-0313 + Buprenorphine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

RDC-0313 + Buprenorphine DRUG

1 and 4 mg (1 dose for each) + 8 mg

RDC-0313 + Buprenorphine

Placebo DRUG

0 mg

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead
• Alkermes, Inc.: collaborator

Study Sites (1)

Langley Porter Psychiatric Hospital

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

ALKS-33; Buprenorphine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 8, 2010
• First Posted: January 12, 2010
• Study Start: January 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: July 1, 2010
• Last Updated: January 11, 2017

Record last verified: 2010-07

Locations

US (1)