NCT05447286

Safety, Tolerability and Pharmacokinetics of NYX-783 and Oxycodone DDI Study

Clinical Evaluation of NMDA Modulator NYX-783 for OUD: Randomized, Double-blind, Placebo-Controlled Study to Assess Safety, Tolerability, and Pharmacokinetics of NYX-783 in Combination With Oxycodone (Study 1)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 58 Years
• Healthy volunteers: Accepted

Summary

This study proposes to examine the safety, tolerability, and pharmacokinetics (PK) of NYX-783 50 mg and 150 mg versus Placebo (PBO) in combination with acute Oxycodone 15 mg and 30 mg in an inpatient randomized, cross-over study in non-treatment seeking non-dependent, opioid experienced individuals with current recreational use.

Detailed description

Outcomes will be cardiovascular (ECG monitoring, heart rate, blood pressure), respiratory, Clinical Opioid Withdrawal Scale (COWS), treatment emergent adverse events (TEAEs), and PK of NYX-783 levels in combination with Oxycodone. Secondary outcomes will be drug effects, subjective opiate withdrawal scale (SOWS), Drug Effects Questionnaire (DEQ), pupillary diameter, the Opioid Symptom Checklist (OSC), craving, stress and pain, and study drug levels during NYX-783 and Oxycodone combination challenge sessions.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	NYX-783	This study proposes to examine the safety, tolerability, and pharmacokinetics (PK) of NYX-783 at 50 mg and 150 mg doses versus Placebo (PBO) in combination with acute Oxycodone 15 mg and 30 mg in an inpatient randomized, cross-over study over 6 experimental sessions.
DRUG	Placebo	This study proposes to examine the safety, tolerability, and pharmacokinetics (PK) of NYX-783 at 50 mg and 150 mg doses versus Placebo (PBO) in combination with acute Oxycodone 15 mg and 30 mg in an inpatient randomized, cross-over study over 6 experimental sessions.
DRUG	Oxycodone	This study proposes to examine the safety, tolerability, and pharmacokinetics (PK) of NYX-783 at 50 mg and 150 mg doses versus Placebo (PBO) in combination with acute Oxycodone 15 mg and 30 mg in an inpatient randomized, cross-over study over 6 experimental sessions.

Timeline

• Start date: 2023-05-15
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2022-07-07
• Last updated: 2025-03-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study