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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Quivive Pharma, Inc.
Study ID
NCT06585163
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Hydrocodone Bitartrate — DRUG
    Hydrocodone bitartrate oral suspension
  • Doxapram Hydrochloride — DRUG
    Doxapram hydrocholoride oral suspension

Study Details

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.

Key Dates

Start date
Sep 30, 2024
Status verified
Sep 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
8 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Sequence A - Hydrocodone alone followed by combined (hydrocodone + doxapram)
    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).
  • Experimental: Sequence B - Combined (hydrocodone + doxapram) followed by hydrocodone alone
    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).

Primary Outcome Measure

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Day 1 to Day 5 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Main CampusClevelandOhio44195
Huan Hsu, MD
[email protected]
216-444-2200

Find similar trials in Cleveland, OH

By research site
Cleveland Clinic Main Campus· Cleveland, OH

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