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Study to Investigate the Safety, Tolerability and Pharmacokinetics of QEV-817 Oral Suspension

NCT06585163 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-09-05

No results posted yet for this study

Summary

This study has been designed to assess the safety, tolerability, and pharmacokinetics of a therapeutic dose of hydrocodone bitartrate with and without an oral dose of doxapram hydrochloride in healthy volunteers who are naltrexone-blocked.

Conditions

  • Healthy

Interventions

DRUG

Hydrocodone Bitartrate

Hydrocodone bitartrate oral suspension

DRUG

Doxapram Hydrochloride

Doxapram hydrocholoride oral suspension

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Quivive Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Ryu Komatsu, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT06585163 on ClinicalTrials.gov