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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
12
1 and 4 mg (1 dose for each) + 8 mg
0 mg
Langley Porter Psychiatric Hospital
San Francisco, California, United States
Pharmacodynamics (PD) of study drug
Time frame: 24 hour period
VAS Scores
Time frame: 24 Hours period
Pupuillometry Assessments
Time frame: 24 Hour Period
Subjective Symptoms
Time frame: 15 min pre and post nal, 3 hrs post bup admin
To determine pharmacokinetics (PK) and evaluate safety and tolerability of study drug
Time frame: 24 hour period
Max plasma concentration
Time frame: 24 Hour Period
Time to maximum plasma concentration
Time frame: 24 Hour Period
Area under the concentration time curve (AUC)
Time frame: 24 Hour Period
Additional PK parameters may be analyzed
Time frame: As appropriate
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