Biological AvailabilityPhase 1NCT00714584
Pharmacokinetics of Naltrexone Following Intravenous and Oral Routes of Administration in Healthy Volunteers
A Phase 1 study testing Naltrexone HCl. in people with Biological Availability, run by Alza Corporation, DE, USA.
Trial summary
The purpose of the study is to compare the pharmacokinetics of naltrexone following i.v. and oral administration in healthy volunteers, and to assess the bioavailability of naltrexone following oral administration. Moreover, safety is assessed. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Biological Availability
- What is being tested?
- Naltrexone HCl.
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- May 2003to Jun 2003
- 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, non smoker, men and nonpregnant nonlactating women
- Weighing a minimum of 60 kg and were within 15% of ideal weight for height as described in the Metropolitan Life Insurance Height and Weight Standards
- Who did not have a history or show presence of drug or alcohol dependence or abuse
Who cannot join
- Known allergy or hypersensitivity to naltrexone
- Usage of prescription medication including opioids (except for birth control medications, sex-hormone replacement, vitamins) within 14 days prior to Day 1, over-the-counter medication (except for vitamin supplements or acetaminophen [less than 2 g/day]) or herbal medication within 3 days prior to Day 1, alcohol, grapefruit juice, or caffeine within 48 hours before dosing
- Consumption of more than 450 mg of caffeine per day (eg, approximately 5 cups of tea, 3 cups of regular coffee, or 8 cans of cola)
About this study
Official title: Pharmacokinetics of Naltrexone Hydrochloride (HCl) Following Intravenous (i.v.) and Oral Routes of Administration in Healthy Subjects
The purpose of the study is to compare the pharmacokinetics of naltrexone following i.v. and oral administration in healthy volunteers, and to assess the bioavailability of naltrexone following oral administration. Moreover, safety is assessed.
Read the detailed description
Naltrexone blocks the effects of opioid (morphine-like) drugs by competitive binding at the opioid receptors in the brain. Naltrexone does not possess morphine-like properties and exhibits minimal pharmacologic activity. Naltrexone is marketed as an oral tablet. A wide range of oral bioavailability values have been reported for naltrexone. The wide range in oral bioavailability of naltrexone appears to be due to differences in assay specificity and the method of estimation of bioavailability (use of total drug, free drug, or urinary excretion data rather than plasma level). This was a single-center, randomized (study drug assigned by chance), open-label, 2-treatment, 2-period crossover study in healthy volunteers. Healthy volunteers were randomly assigned to 1 of 2 treatment sequences (AB or BA) with a washout period of 6 to 14 days between treatments. The washout period commenced the day of dosing, after drug administration. Blood samples for determination of blood naltrexone levels were collected at scheduled time points from the arm opposite to the 1 selected for naltrexone i.v. administration. Pulse, blood pressure, breathing rate, body temperature were measured at the times listed in the study schema. Healthy volunteers remained at the research facility for blood sample collection periods and were monitored for adverse events throughout the treatment periods.
Treatment A: 1 mg naltrexone HCl administered i.v. over 15 minutes (naltrexone i.v.). Treatment B: 50 mg naltrexone HCl administered orally (naltrexone oral).
- Conditions
- Biological Availability
- Being tested
- Naltrexone HCl.
- Keywords
- Infusions, Intravenous, Safety, Pharmacokinetics, Naltrexone, Administration, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone HCl.Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the pharmacokinetics of naltrexone following i.v. and oral routes of administration in healthy volunteers, and to assess the absolute bioavailability of naltrexone following oral administration.
Secondary outcomes (1)
Assessment of safety. Vital signs, Physical examination, clinical laboratory tests, and electrocardiogram were performed at screening and study termination. Additionally, vital signs were recorded on Days 1 and 2 of both treatment periods.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startMay 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biological AvailabilityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alza Corporation, DE, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alza Corporation Clinical Trial, Study director, Alza Corporation, DE, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714584
- Sponsor's protocol ID
- CR003256
- Status last verified
- Apr 2010
- First submitted
- 10 Jul 2008
- Last updated
- 19 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Naltrexone Hydrochloride (HCl) Following Intravenous (i.v.) and Oral Routes of Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00714584
- Acronym / sponsor ID
- CR003256
- Conditions
- Biological Availability
- Keywords
- Infusions, Intravenous, Safety, Pharmacokinetics, Naltrexone, Administration, Oral
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Alza Corporation, DE, USAIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Study completion
- Jun 2003 (actual)
- First posted
- 14 Jul 2008 (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.
The purpose of the study is to compare the pharmacokinetics of naltrexone following i.v. and oral administration in healthy volunteers, and to assess the bioavailability of naltrexone following oral administration. Moreover, safety is assessed.
Detailed description
Naltrexone blocks the effects of opioid (morphine-like) drugs by competitive binding at the opioid receptors in the brain. Naltrexone does not possess morphine-like properties and exhibits minimal pharmacologic activity. Naltrexone is marketed as an oral tablet. A wide range of oral bioavailability values have been reported for naltrexone. The wide range in oral bioavailability of naltrexone appears to be due to differences in assay specificity and the method of estimation of bioavailability (use of total drug, free drug, or urinary excretion data rather than plasma level). This was a single-center, randomized (study drug assigned by chance), open-label, 2-treatment, 2-period crossover study in healthy volunteers. Healthy volunteers were randomly assigned to 1 of 2 treatment sequences (AB or BA) with a washout period of 6 to 14 days between treatments. The washout period commenced the day of dosing, after drug administration. Blood samples for determination of blood naltrexone levels were collected at scheduled time points from the arm opposite to the 1 selected for naltrexone i.v. administration. Pulse, blood pressure, breathing rate, body temperature were measured at the times listed in the study schema. Healthy volunteers remained at the research facility for blood sample collection periods and were monitored for adverse events throughout the treatment periods.
Treatment A: 1 mg naltrexone HCl administered i.v. over 15 minutes (naltrexone i.v.). Treatment B: 50 mg naltrexone HCl administered orally (naltrexone oral).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy, non smoker, men and nonpregnant nonlactating women
- Weighing a minimum of 60 kg and were within 15% of ideal weight for height as described in the Metropolitan Life Insurance Height and Weight Standards
- Who did not have a history or show presence of drug or alcohol dependence or abuse
Key exclusion criteria (3 listed)
- Known allergy or hypersensitivity to naltrexone
- Usage of prescription medication including opioids (except for birth control medications, sex-hormone replacement, vitamins) within 14 days prior to Day 1, over-the-counter medication (except for vitamin supplements or acetaminophen [less than 2 g/day]) or herbal medication within 3 days prior to Day 1, alcohol, grapefruit juice, or caffeine within 48 hours before dosing
- Consumption of more than 450 mg of caffeine per day (eg, approximately 5 cups of tea, 3 cups of regular coffee, or 8 cans of cola)
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 |
|---|---|---|
| Naltrexone HCl. | Drug | – |
Primary outcome
Evaluate the pharmacokinetics of naltrexone following i.v. and oral routes of administration in healthy volunteers, and to assess the absolute bioavailability of naltrexone following oral administration.
1 secondary outcome
Assessment of safety. Vital signs, Physical examination, clinical laboratory tests, and electrocardiogram were performed at screening and study termination. Additionally, vital signs were recorded on Days 1 and 2 of both treatment periods.
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 19 May 2011.
- Pharmacokinetics of naltrexone following intravenous and oral routes of administration in healthy subjectsLink provided by the sponsor.
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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.
Alza Corporation Clinical Trial study director
Alza Corporation, DE, USA
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naltrexone HCl. in people with Biological Availability, run by Alza Corporation, DE, USA.
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 3 inclusion and 3 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 19 May 2011. 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?
Evaluate the pharmacokinetics of naltrexone following i.v. and oral routes of administration in healthy volunteers, and to assess the absolute bioavailability of naltrexone following oral administration.. 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 19 May 2011.