Clinical trial NCT02126917: A Study to Determine the Influence of Co-ingestion of Alcohol on Hydrocodone Bitartrate Extended Release (HC-ER)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase 1
Alcohol
Hydrocodone Bitartrate
Pharmacokinetics
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2014-04-30
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: Assess the rate and extent of absorption of HC-ER 50 mg capsule following co-ingestion of alcohol under fasted conditions.
timeFrame: Day 1 through Day 18
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Zogenix, Inc.
name: James Kissling, MD
role: PRINCIPAL_INVESTIGATOR
References: