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Sequence A - Hydrocodone alone followed by combined (hydrocodone + doxapram) for Healthy Subjects

Phase 1
Waitlist Available
Led By Ryu Komatsu, MD
Research Sponsored by Quivive Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Male or female aged 18-55 years, inclusive, on the day of screening.
* Willing to abstain from alcohol and strenuous physical activity (i.e., strenuous, or unaccustomed weightlifting, running, bicycling, etc.) from 48 hours prior to study treatment administration until discharge from the clinical unit and prior to each outpatient visit.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 2 and day 4
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 2 and day 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 2 and day 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Secondary study objectives
Plasma PK Parameters (AUC0-inf)
Plasma PK Parameters (Cmax)
Plasma PK Parameters (Tmax)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sequence B - Combined (hydrocodone + doxapram) followed by hydrocodone aloneExperimental Treatment2 Interventions
Subjects randomized to Sequence B will first receive a single combined administration of hydrocodone bitartrate and doxapram hydrocholoride on Study Day-2 and then receive hydrocodone alone on study Day-4 (after a 48 hour wash-out).
Group II: Sequence A - Hydrocodone alone followed by combined (hydrocodone + doxapram)Experimental Treatment2 Interventions
Subjects randomized to Sequence A will first receive a single oral administration of hydrocodone bitartrate alone on Study Day-2 and then receive a combination of hydrocodone bitartrate and doxapram hydrocholoride on study Day-4 (after a 48 hour wash-out).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydrocodone Bitartrate
2010
Completed Phase 3
~450

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Quivive Pharma, Inc.Lead Sponsor
National Institute on Drug Abuse (NIDA)NIH
2,536 Previous Clinical Trials
3,247,353 Total Patients Enrolled
Ryu Komatsu, MDPrincipal InvestigatorThe Cleveland Clinic
1 Previous Clinical Trials
80 Total Patients Enrolled
~5 spots leftby Dec 2024
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