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

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.