A Study to Determine the Influence of Co-ingestion of Alcohol on Hydrocodone Bitartrate Extended Release (HC-ER)

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HC-ER + 20% Alcohol; Drug: HC-ER + 40% Alcohol; Drug: HC-ER + 0% Alcohol

• Registration Number: NCT02126917
• Lead Sponsor: Zogenix, Inc.

Brief Summary

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

Detailed Description

Determine the influence of co-ingestion of alcohol on the safety, pharmacokinetics, and relative bioavailability of HC-ER 50 mg under fasted conditions

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2014-04
• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-30
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.
• Positive urine test for drugs of abuse.
• Positive test for, or had been treated for hepatitis B, hepatitis C or HIV.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HC-ER + 20% Alcohol	HC-ER + 20% Alcohol	Open-label, single-dose, 3-period cross-over. All patients fulfilling inclusion/exclusion received HC-ER 50 mg capsule with 20% Alcohol.
HC-ER + 40% Alcohol	HC-ER + 40% Alcohol	Open-label, single-dose, 3-period cross-over. All patients fulfilling inclusion/exclusion received HC-ER 50 mg capsule with 40% Alcohol.
HC-ER + 0% Alcohol	HC-ER + 0% Alcohol	Open-label, single-dose, 3-period cross-over. All patients fulfilling inclusion/exclusion received HC-ER 50 mg capsule with 0% Alcohol.

Primary Outcome Measures

Name	Time	Method
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