Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy PK Drug-drug Interaction Study

Keywords

pharmacokineticshydrocodonedoxapramoralsafetytolerability

Outcome Measures

Primary Outcomes (1)

Number of Participants With Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs
Number of participants with clinically meaningful changes from baseline in physical examination, vital signs, 12-lead ECG assessment and/or pulse oximetry
Day 1 to Day 5

Secondary Outcomes (3)

Plasma PK Parameters (Cmax)
Day 2 and Day 4
Plasma PK Parameter (AUC0-24h)
Day 2 and Day 4
Plasma PK Parameter (Tmax)
Day 2 and Day 4

Study Arms (2)

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

EXPERIMENTAL

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).

Drug: Hydrocodone BitartrateDrug: Hydrocodone Bitartrate + Doxapram Hydrochloride

Sequence B - Combined (hydrocodone + doxapram) followed by hydrocodone alone

EXPERIMENTAL

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).

Drug: Hydrocodone BitartrateDrug: Hydrocodone Bitartrate + Doxapram Hydrochloride

Interventions

Hydrocodone BitartrateDrug

Hydrocodone bitartrate oral suspension

Also known as: NDC 51634-0014

Sequence A - Hydrocodone alone followed by combined (hydrocodone + doxapram)Sequence B - Combined (hydrocodone + doxapram) followed by hydrocodone alone

Hydrocodone Bitartrate + Doxapram HydrochlorideDrug

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Hydrocodone Bitartrate + Doxapram Hydrochloride
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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.

Sponsors & Collaborators

Quivive Pharma, Inc.
Industrylead
National Institute on Drug Abuse (NIDA)
NIHcollaborator

Study Sites (1)

Frontage Clinical Services, Inc.

Secaucus, New Jersey, 07094, United States

MeSH Terms

Interventions

HydrocodoneDoxapram

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title: Peter J Rix, Chief Scientific Officer
Organization: Quivive Pharma, Inc.

Study Officials

Frank Lee, MD
Frontage Clinical Services, Inc.
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: LTE60
Restrictive Agreement: Yes

Enrollment

8 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: BASIC SCIENCE
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 1, 2024

First Posted

September 5, 2024

Study Start

August 18, 2025

Actual (reported)

You may not qualify if:

Female subject who is pregnant or lactating.
Have any vital sign abnormalities as described in the protocol.
Recreational opioid user who has used opioids for non-therapeutic purposes (i.e., for psychoactive effects) or who is physically dependent on any illicit or prescription opioid, and/or currently participating in a treatment program for individuals with opioid dependence.
Known allergy or history of significant adverse reaction to hydrocodone or its metabolites, other opioids, or related compounds, doxapram hydrochloride, naltrexone, naloxone, or to any of the excipients in QEV-817.
History of or currently has hypoventilation syndrome or sleep apnea and is on non-invasive ventilation (e.g., CPAP).
Clinically meaningful infection/injury/illness within one month prior to screening.
Active malignancy (excluding squamous or basal cell carcinoma of the skin) within 5 years of screening.
Subjects with hepatic impairment as defined by screening alanine transaminase (ALT), aspartate transaminase (AST) or total bilirubin \>3× upper limit of normal (ULN).
Subjects with renal impairment as defined by screening estimated creatinine clearance/eGFR (estimated glomerular filtration rate) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation is \<60 mL/min/1.73 m2.
Donation of blood (\>450 mL) or significant blood loss within 56 days.
Current (or recent history of) psychiatric illness or mental impairment.
Clinically meaningful current (or history of) unstable chronic disease; medical abnormality; or significant cardiovascular (including significant cardiovascular impairment, uncompensated heart failure, severe coronary artery disease, severe hypertension), endocrine, gastrointestinal, neurological disorder (including cognitive disorders); or metabolic disease.
Currently active (or history of) epilepsy, seizure disorder, serious head injury, cerebral vascular accident, or cerebral edema.
Current treatment with monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, sympathomimetic drugs, neuromuscular blocking agents, narcotics, antihistamines, antipsychotics, antianxiety agents, or other central nervous system (CNS) depressants.
Use of any prescription or over the counter (OTC) medications including food supplements and herbal medications (e.g., St. John's wort), with the exception of contraceptive medications or a daily multivitamin, within fourteen (14) days prior to study treatment administration. Use of CYP3A4 inhibitors or inducers is prohibited within 28 days prior to the first treatment and throughout the treatment and follow-up periods.
+2 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

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

Sequence B - Combined (hydrocodone + doxapram) followed by hydrocodone alone

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

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

Sequence B - Combined (hydrocodone + doxapram) followed by hydrocodone alone

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations