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

Single-center, Open-Label, 3-Period Crossover, Phase 1 Study to Evaluate the Pharmacokinetics of Hydrocodone Bitartrate Extended-Release (HC-ER) Capsules 50 mg When Co-Administered With Alcohol in Healthy Subjects Under Fasted Conditions

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: HC-ER + 40% Alcohol; Drug: HC-ER + 20% Alcohol; Drug: HC-ER + 0% Alcohol

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: HC-ER + 40% Alcohol; HC-ER 50 mg + 240 mL solution of 40% alcohol/orange juice in fasted state; Other Names: Zohydro ER
Experimental: 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.	Drug: HC-ER + 20% Alcohol; HC-ER 50 mg + 240 mL solution of 20% alcohol/orange juice in fasted state; Other Names: Zohydro ER
Experimental: 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.	Drug: HC-ER + 0% Alcohol; HC-ER 50 mg + 240 mL solution of 0% alcohol/orange juice in fasted state; Other Names: Zohydro ER

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Zogenix, Inc.
• Investigators: Principal Investigator: James Kissling, MD, Zogenix, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: April 15, 2014
• First Submitted That Met QC Criteria: April 28, 2014
• First Posted (Estimate): April 30, 2014

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Phase 1; Alcohol; Hydrocodone Bitartrate
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Ethanol; Hydrocodone
• Other Study ID Numbers: ZX002-0901