Last updated on November 2019

A Study Using Functional Magnetic Resonance Imaging to Evaluate the Effect of NKTR-181 on Brain Activity in Healthy Non-physically Dependent Recreational Opioid Users.

Brief description of study

The main purpose of this study is to evaluate the effect of NKTR-181 on brain activity in healthy, non-physically dependent recreational opioid users. This study will last about 88 days for each participant.

Detailed Study Description

This study is a single-center study in which approximately 24 subjects will be randomized to one of two treatment groups. Subjects will enter a screening period between Day -28 and Day -2. Upon meeting all criteria for enrollment, on Day -1 subjects will enter the clinical research study unit (CRSU) for a 2-day confinement. On Day 1, subjects will undergo a baseline MRI and will then be randomized to NKTR-181 or oxycodone immediate release (IR). Once randomized, subjects will receive a single dose of study drug (NKTR-181 or oxycodone IR) and matched alternate-treatment placebo. Subjects will undergo a series of four fMRIs (functional magnetic resonance imaging) post dose (at hours 1, 2, 4, and 8). Pre-dose and at post-dose hours 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24, pupillometry will be performed and PK blood samples will be drawn. On Day 2, subjects will be discharged from the CRSU. Following a 14- to 17-day safety follow-up period, subjects will return to the research facility clinic for the End of Study (EOS) visit (Day 16-19).

Clinical Study Identifier: NCT03802227

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Investigator Site - Richmond

Richmond, VA United States
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