NCT02126917

Brief Summary

To determine the influence of co-ingestion of alcohol on HC-ER.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
Last Updated

November 10, 2022

Status Verified

April 1, 2014

Enrollment Period

1 month

First QC Date

April 15, 2014

Last Update Submit

November 8, 2022

Conditions

Healthy

Keywords

Phase 1AlcoholHydrocodone BitartratePharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Assess the rate and extent of absorption of HC-ER 50 mg capsule following co-ingestion of alcohol under fasted conditions.

    Day 1 through Day 18

Study Arms (3)

HC-ER + 40% Alcohol

EXPERIMENTAL

Open-label, single-dose, 3-period cross-over. All patients fulfilling inclusion/exclusion received HC-ER 50 mg capsule with 40% Alcohol.

Drug: HC-ER + 40% Alcohol

HC-ER + 20% Alcohol

EXPERIMENTAL

Open-label, single-dose, 3-period cross-over. All patients fulfilling inclusion/exclusion received HC-ER 50 mg capsule with 20% Alcohol.

Drug: HC-ER + 20% Alcohol

HC-ER + 0% Alcohol

EXPERIMENTAL

Open-label, single-dose, 3-period cross-over. All patients fulfilling inclusion/exclusion received HC-ER 50 mg capsule with 0% Alcohol.

Drug: HC-ER + 0% Alcohol

Interventions

HC-ER + 40% AlcoholDRUG

HC-ER 50 mg + 240 mL solution of 40% alcohol/orange juice in fasted state

Also known as: Zohydro ER
HC-ER + 40% Alcohol
HC-ER + 20% AlcoholDRUG

HC-ER 50 mg + 240 mL solution of 20% alcohol/orange juice in fasted state

Also known as: Zohydro ER
HC-ER + 20% Alcohol
HC-ER + 0% AlcoholDRUG

HC-ER 50 mg + 240 mL solution of 0% alcohol/orange juice in fasted state

Also known as: Zohydro ER
HC-ER + 0% Alcohol

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females, ages 21 to 45.
  • Female, must be of non-childbearing potential.
  • Non-smokers for at least 3 months or light smokers (less than 10 pack-years).
  • History of moderate consumption of between 7-21 units of alcohol per week.
  • Weighed at least 65 kg with a BMI ≥19 and ≤35 kg/m2.
  • Were medically healthy with no clinically significant abnormalities.
  • Voluntarily consented to participate in the study.
  • Were prepared to be compliant with the study procedures.

You may not qualify if:

  • Women who were pregnant or breastfeeding.
  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
  • History or presence of alcoholism or drug abuse.
  • Hypersensitivity or idiosyncratic reaction to morphine, hydrocodone (Vicodin) or other opioids; naltrexone, naloxone, or other opioid antagonist.
  • History of no alcohol intake (alcohol-naive) or less than moderate alcohol intake.
  • History of alcohol intake exceeding the equivalence of 21 units/week or exceeding the average of 3 drinks per day.
  • Surgery of the gastrointestinal tract which would interfere with absorption of the study drug.
  • Taken hepatic enzyme inducing drugs (e.g., Nizoral, Tagamet) within the previous 3 months.
  • Taken prescription medications within the previous 14 days or over the counter (OTC) medications within the previous 7 days prior to Day 1 Period 1.
  • Sitting blood pressure was less than 110/45 mmHg at screening.
  • On a special diet (except for vegetarians who agree to abide by study diet) during the 28 days prior to the first dose and throughout the study.
  • Significant blood donation or loss within 56 days prior to first dose of HC-ER.
  • Plasma donation within 7 days prior to first dose of HC-ER.
  • Hemoglobin value less than 12.0 g/dL.
  • Participated in another clinical trial within 28 days prior to first dose of HC-ER.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

EthanolHydrocodone

Intervention Hierarchy (Ancestors)

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

Study Officials

  • James Kissling, MD

    Zogenix, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 15, 2014

First Posted

April 30, 2014

Study Start

November 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

November 10, 2022

Record last verified: 2014-04