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

Sponsor

Zogenix, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02126917

Collaborator

(none)

Enrollment

Arms

Duration (Days)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: HC-ER + 40% Alcohol Drug: HC-ER + 20% Alcohol Drug: HC-ER + 0% Alcohol	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.