HealthyPhase 1NCT02126917
A Study to Determine the Influence of Co-ingestion of Alcohol on Hydrocodone Bitartrate Extended Release (HC-ER)
A Phase 1 study testing HC-ER + 40% Alcohol, HC-ER + 20% Alcohol and HC-ER + 0% Alcohol in people with Healthy, run by Zogenix, Inc..
Trial summary
To determine the influence of co-ingestion of alcohol on HC-ER. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HC-ER + 40% Alcohol, HC-ER + 20% Alcohol and HC-ER + 0% Alcohol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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
To determine the influence of co-ingestion of alcohol on HC-ER.
Read the 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
- Conditions
- Healthy
- Being tested
- HC-ER + 40% Alcohol, HC-ER + 20% Alcohol, HC-ER + 0% Alcohol
- Keywords
- Phase 1, Alcohol, Hydrocodone Bitartrate, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HC-ER + 40% AlcoholDrug
Also called Zohydro ER
HC-ER 50 mg + 240 mL solution of 40% alcohol/orange juice in fasted state
HC-ER + 20% AlcoholDrug
Also called Zohydro ER
HC-ER 50 mg + 240 mL solution of 20% alcohol/orange juice in fasted state
HC-ER + 0% AlcoholDrug
Also called Zohydro ER
HC-ER 50 mg + 240 mL solution of 0% alcohol/orange juice in fasted state
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: HC-ER + 0% Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the rate and extent of absorption of HC-ER 50 mg capsule following co-ingestion of alcohol under fasted conditions.
Measured: Day 1 through Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startNov 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zogenix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Kissling, MD, Principal investigator, Zogenix, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126917
- Sponsor's protocol ID
- ZX002-0901
- Status last verified
- Apr 2014
- First submitted
- 15 Apr 2014
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02126917
- Acronym / sponsor ID
- ZX002-0901
- Conditions
- Healthy
- Keywords
- Phase 1, Alcohol, Hydrocodone Bitartrate, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zogenix, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HC-ER + 40% Alcohol | Experimental | Drug: HC-ER + 40% AlcoholOpen-label, single-dose, 3-period cross-over. All patients fulfilling inclusion/exclusion received HC-ER 50 mg capsule with 40% Alcohol. |
| HC-ER + 20% Alcohol | Experimental | Drug: HC-ER + 20% AlcoholOpen-label, single-dose, 3-period cross-over. All patients fulfilling inclusion/exclusion received HC-ER 50 mg capsule with 20% Alcohol. |
| HC-ER + 0% Alcohol | Experimental | Drug: HC-ER + 0% AlcoholOpen-label, single-dose, 3-period cross-over. All patients fulfilling inclusion/exclusion received HC-ER 50 mg capsule with 0% Alcohol. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HC-ER + 40% AlcoholAlso: Zohydro ERHC-ER 50 mg + 240 mL solution of 40% alcohol/orange juice in fasted state | Drug | HC-ER + 40% Alcohol |
| HC-ER + 20% AlcoholAlso: Zohydro ERHC-ER 50 mg + 240 mL solution of 20% alcohol/orange juice in fasted state | Drug | HC-ER + 20% Alcohol |
| HC-ER + 0% AlcoholAlso: Zohydro ERHC-ER 50 mg + 240 mL solution of 0% alcohol/orange juice in fasted state | Drug | HC-ER + 0% Alcohol |
Primary outcome
Assess the rate and extent of absorption of HC-ER 50 mg capsule following co-ingestion of alcohol under fasted conditions.
Time frame: Day 1 through Day 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Kissling, MD principal investigator
Zogenix, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HC-ER + 40% Alcohol, HC-ER + 20% Alcohol and HC-ER + 0% Alcohol in people with Healthy, run by Zogenix, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the rate and extent of absorption of HC-ER 50 mg capsule following co-ingestion of alcohol under fasted conditions. (time frame: Day 1 through Day 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.