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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Study to Evaluate the Pharmacodynamics of RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy Adults

Conditions
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Substance-Related Disorders

Intervention / Treatment
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* Drug: RDC-0313 + Buprenorphine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RDC-0313 + Buprenorphine<br>Cohort 1 (1 and 4 mg) + 8 mg Cohort 2 (dependent on Cohort 1 results) | Drug: RDC-0313 + Buprenorphine<br>* 1 and 4 mg (1 dose for each) + 8 mg<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 0 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |