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

NCT05447286 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-03-25

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Rajita Sinha, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
58 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-15
Primary Completion
2024-12-30
Completion
2024-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05447286 on ClinicalTrials.gov