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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01046539

Enrollment

Registered

2010-01-12

Start date

2010-01-31

Completion date

2010-07-31

Last updated

2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance-Related Disorders

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.

Interventions

DRUGRDC-0313 + Buprenorphine

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

DRUGPlacebo

0 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	Time frame
To determine pharmacokinetics (PK) and evaluate safety and tolerability of study drug	24 hour period
Additional PK parameters may be analyzed	As appropriate
Max plasma concentration	24 Hour Period
Time to maximum plasma concentration	24 Hour Period
Area under the concentration time curve (AUC)	24 Hour Period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026