HealthyPhase 1NCT02117141
To Assess the Rate and Extent of Absorption of Hydrocodone From 20 mg Hydrocodone Bitartrate Extended-Release Capsules
A Phase 1 study testing HC-ER 20 mg capsule (fasted) and HC-ER 20 mg capsule (fed) in people with Healthy, run by Zogenix, Inc..
Trial summary
Assess the rate and extent of absorption of hydrocodone from a 20 mg HC-ER capsule in both fed and fasted states Evaluate the safety and tolerability of the test compound administered orally Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HC-ER 20 mg capsule (fasted) and HC-ER 20 mg capsule (fed)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jun 2002to Jun 2002
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Volunteers.
- Aged greater than 18 and less than 45 years.
- Were medically healthy with no clinically significant abnormality on the basis of medical history, physical examination and laboratory evaluations
- Volunteer consented to participate in the study.
- Female volunteers were included if they were surgically sterile, or using an acceptable method of birth control defined as either oral, injectable, implantable, or barrier methods of contraception (ie, diaphragm with spermicidal cream, intrauterine device (IUD) with spermicidal cream or condom with spermicidal cream).
Who cannot join
- Participants were in a clinical trial within the previous 90 days or participants in a narcotic analgesic study within the previous 12 months.
- Deviation in excess of 10% from the ideal body weight for height according to the Metropolitan Life Insurance Tables (1983 edition).
- History of drug or alcohol abuse at any time in the past
- History of hypersensitivity to the study drug or similar compounds or to acetaminophen.
- Therapeutic use (for any reason) of narcotic analgesics within the previous year.
- Subjects who used tricyclic antidepressants or monoamine oxidase inhibitors at any time in the past.
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- Subjects with a history of, or clinical signs suggestive of, chronic obstructive airways disease.
- Receipt of any prescription medication (except birth control) within 2 weeks prior to entry into the study or receipt of non-prescription or over-the-counter medication within one week of study commencement. (Vitamin supplements were acceptable).
- Blood donation within the 90 days previous to study entry.
- Female volunteers with a positive serum pregnancy test, or at risk of becoming pregnant during the study.
- Volunteers with a history of smoking (must not have smoked within the last 6 months).
- Volunteers with any clinical/biochemical impairment of liver function, or receipt of known hepatic enzyme inducing or inhibiting agents within 30 days prior to entry into the study.
- History or presence of significant hepatic, renal, endocrine, cardiac, nervous, gastrointestinal, pulmonary or metabolic disorders.
- Any condition or history that the investigator considered might increase the risk to the volunteer or interfere with the evaluation of data.
About this study
Official title: A Pilot Study in Healthy Volunteers to Assess the Rate and Extent of Absorption of Hydrocodone From 20 mg Hydrocodone Bitartrate Extended-Release (HC-ER) Capsules, in Both Fed and Fasted States
- Assess the rate and extent of absorption of hydrocodone from a 20 mg HC-ER capsule in both fed and fasted states
- Evaluate the safety and tolerability of the test compound administered orally
Read the detailed description
Safety parameters assessed included medical history, physical examination, vital signs, 12-lead ECGs, clinical laboratory testing and adverse event assessment.
- Conditions
- Healthy
- Being tested
- HC-ER 20 mg capsule (fasted), HC-ER 20 mg capsule (fed)
- Keywords
- Food Effect, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HC-ER 20 mg capsule (fasted)Drug
Also called Zohydro ER
Single oral dose HC-ER 20 mg capsule after overnight fast (fasted)
HC-ER 20 mg capsule (fed)Drug
Also called Zohydro ER
Single oral dose HC-ER 20 mg capsule after high fat meal (fed)
| Study group | Role | What they receive |
|---|---|---|
| HC-ER 20 mg capsule (fasted) | Experimental | Single oral dose of a HC-ER 20 mg capsule (fasted) Receives: Drug: HC-ER 20 mg capsule (fasted) |
| HC-ER 20 mg capsule (fed) | Experimental | Single oral dose of HC-ER 20mg capsule (fed) Receives: Drug: HC-ER 20 mg capsule (fed) |
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 hydrocodone from a 20 mg HC-ER capsule in both fed and fast states
Measured: Day 1-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startJun 2002
- Primary completionJun 2002
- Study completionJun 2002
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zogenix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- A. Johnston Stewart, MB, MRCGP, Principal investigator, Zogenix, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117141
- Sponsor's protocol ID
- ELN-0302002
- 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
- A Pilot Study in Healthy Volunteers to Assess the Rate and Extent of Absorption of Hydrocodone From 20 mg Hydrocodone Bitartrate Extended-Release (HC-ER) Capsules, in Both Fed and Fasted States
- ClinicalTrials.gov ID
- NCT02117141
- Acronym / sponsor ID
- ELN-0302002
- Conditions
- Healthy
- Keywords
- Food Effect, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Zogenix, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2002
- Primary completion
- Jun 2002 (actual)
- Study completion
- Jun 2002 (actual)
- First posted
- 17 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.
- Assess the rate and extent of absorption of hydrocodone from a 20 mg HC-ER capsule in both fed and fasted states
- Evaluate the safety and tolerability of the test compound administered orally
Detailed description
Safety parameters assessed included medical history, physical examination, vital signs, 12-lead ECGs, clinical laboratory testing and adverse event assessment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HC-ER 20 mg capsule (fasted) | Experimental | Drug: HC-ER 20 mg capsule (fasted)Single oral dose of a HC-ER 20 mg capsule (fasted) |
| HC-ER 20 mg capsule (fed) | Experimental | Drug: HC-ER 20 mg capsule (fed)Single oral dose of HC-ER 20mg capsule (fed) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Volunteers.
- Aged greater than 18 and less than 45 years.
- Were medically healthy with no clinically significant abnormality on the basis of medical history, physical examination and laboratory evaluations
- Volunteer consented to participate in the study.
- Female volunteers were included if they were surgically sterile, or using an acceptable method of birth control defined as either oral, injectable, implantable, or barrier methods of contraception (ie, diaphragm with spermicidal cream, intrauterine device (IUD) with spermicidal cream or condom with spermicidal cream).
Key exclusion criteria (14 listed)
- Participants were in a clinical trial within the previous 90 days or participants in a narcotic analgesic study within the previous 12 months.
- Deviation in excess of 10% from the ideal body weight for height according to the Metropolitan Life Insurance Tables (1983 edition).
- History of drug or alcohol abuse at any time in the past
- History of hypersensitivity to the study drug or similar compounds or to acetaminophen.
- Therapeutic use (for any reason) of narcotic analgesics within the previous year.
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 20 mg capsule (fasted)Also: Zohydro ERSingle oral dose HC-ER 20 mg capsule after overnight fast (fasted) | Drug | HC-ER 20 mg capsule (fasted) |
| HC-ER 20 mg capsule (fed)Also: Zohydro ERSingle oral dose HC-ER 20 mg capsule after high fat meal (fed) | Drug | HC-ER 20 mg capsule (fed) |
Primary outcome
Assess the rate and extent of absorption of hydrocodone from a 20 mg HC-ER capsule in both fed and fast states
Time frame: Day 1-2
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.
A. Johnston Stewart, MB, MRCGP principal investigator
Zogenix, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HC-ER 20 mg capsule (fasted) and HC-ER 20 mg capsule (fed) 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 5 inclusion and 14 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 hydrocodone from a 20 mg HC-ER capsule in both fed and fast states (time frame: Day 1-2). 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.