HealthyNCT00880841
A Single-Dose Study of an Investigational Capsule Formulation of 2 mg/0.5 mg Buprenorphine/Naloxone
An observational study of Healthy, run by NanoSHIFT LLC at 1 site in United States.
Trial summary
A single-dose pilot study of an investigational capsule formulation of 2 mg/.05 mg Buprenorphine/Naloxone. NIDA Contract No. HHSN271200577414C Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Buprenorphine / Naloxone
- Type of treatment
- Pill or oral medicine
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to May 2009
- Phase
- Observational
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy normals between the ages of 18 and 55 (inclusive)
Who may be able to join
- Subject must be a male or non-pregnant, non-breastfeeding female.
- Subject must be between 18 and 55 years of age (inclusive).
- Subject's Body Mass Index (BMI) must be between 18 and 30 kg/m2 (inclusive), and subject must weigh a minimum of 50 kg (110 lbs).
- Female subjects - not surgically sterile for at least 6 months or at least 2 years postmenopausal - must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. Approved forms of contraception are abstinence, hormonal (oral, implant, transdermal, vaginal, or injection) in use at least 3 consecutive months prior to the first dose of study medication, double barrier (condom with spermicide; diaphragm with spermicide), intrauterine device (IUD), or vasectomized partner (6 months minimum since vasectomy).
- Subject must voluntarily consent to participate in this study and provide their written informed consent prior to start of any study-specific procedures.
- Subject is willing and able to remain in the study unit for the entire duration of the confinement period and return for any outpatient visits.
Who cannot join
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, metabolic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
- Has a clinically significant abnormal finding on the physical exam, medical history, ECG, or clinical laboratory results at screening.
- History or presence of allergic or adverse response to buprenorphine, naloxone, naltrexone, opioids, or any comparable or similar products.
- Has been on a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
- Has donated blood or plasma within 30 days prior to the first dose of study medication.
- Has participated in another clinical trial within 30 days prior to the first dose of study medication.
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- Has used any over-the-counter (OTC) medication, including nutritional supplements, within 7 days prior to the first dose of study medication.
- Has used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication.
- Has been treated with any known enzyme altering drugs, such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication.
- Has smoked or used tobacco products within 60 days prior to the first dose of study medication.
- Has history of substance abuse or dependence (including alcohol, opioids, or intravenous drug abuse)
- Is a female with a positive pregnancy test result.
- Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
- Has a positive urine alcohol test at screening or a positive ethanol breath test at check-in for the study period or has consumed alcohol within 48 hours prior to screening or check-in for the study period.
- Has had a positive test for, or has been treated for hepatitis B, hepatitis C, or HIV.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, 1-Period, 1-Treatment Pilot Study of an Investigational Capsule Formulation of 2 mg/.05 mg Buprenorphine/Naloxone Under Fasting Conditions
A single-dose pilot study of an investigational capsule formulation of 2 mg/.05 mg Buprenorphine/Naloxone.
NIDA Contract No. HHSN271200577414C
- Conditions
- Healthy
- Being tested
- Buprenorphine / Naloxone
- Keywords
- healthy normals, phase 1, phase 1a study for healthy normals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine / NaloxoneDrug
Also called NanoBUP
oral formulation of buprenorphine / naloxone
| Study group | Role | What they receive |
|---|---|---|
| no treatment | phase 1a study for healthy normals Receives: Drug: Buprenorphine / Naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetic profile of an investigational formulation of buprenorphine HCl/naloxone HCl 2mg/0.5mg oral capsules
Measured: pk blood draws over a 72 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2009
- Study completionMay 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- NanoSHIFT LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Leibowitz, MD, Principal investigator, CEDRA Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880841
- Sponsor's protocol ID
- 20-A93-AU
- Status last verified
- Jun 2017
- First submitted
- 13 Apr 2009
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, 1-Period, 1-Treatment Pilot Study of an Investigational Capsule Formulation of 2 mg/.05 mg Buprenorphine/Naloxone Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT00880841
- Acronym / sponsor ID
- 20-A93-AU
- Conditions
- Healthy
- Keywords
- healthy normals, phase 1, phase 1a study for healthy normals
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- NanoSHIFT LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 14 Apr 2009 (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.
A single-dose pilot study of an investigational capsule formulation of 2 mg/.05 mg Buprenorphine/Naloxone.
NIDA Contract No. HHSN271200577414C
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no treatment | – | Drug: Buprenorphine / Naloxonephase 1a study for healthy normals |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy normals between the ages of 18 and 55 (inclusive)
Key inclusion criteria (6 listed)
- Subject must be a male or non-pregnant, non-breastfeeding female.
- Subject must be between 18 and 55 years of age (inclusive).
- Subject's Body Mass Index (BMI) must be between 18 and 30 kg/m2 (inclusive), and subject must weigh a minimum of 50 kg (110 lbs).
- Female subjects - not surgically sterile for at least 6 months or at least 2 years postmenopausal - must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. Approved forms of contraception are abstinence, hormonal (oral, implant, transdermal, vaginal, or injection) in use at least 3 consecutive months prior to the first dose of study medication, double barrier (condom with spermicide; diaphragm with spermicide), intrauterine device (IUD), or vasectomized partner (6 months minimum since vasectomy).
- Subject must voluntarily consent to participate in this study and provide their written informed consent prior to start of any study-specific procedures.
Key exclusion criteria (15 listed)
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, metabolic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
- Has a clinically significant abnormal finding on the physical exam, medical history, ECG, or clinical laboratory results at screening.
- History or presence of allergic or adverse response to buprenorphine, naloxone, naltrexone, opioids, or any comparable or similar products.
- Has been on a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
- Has donated blood or plasma within 30 days prior to the first dose of study medication.
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 |
|---|---|---|
| Buprenorphine / NaloxoneAlso: NanoBUPoral formulation of buprenorphine / naloxone | Drug | no treatment |
Primary outcome
pharmacokinetic profile of an investigational formulation of buprenorphine HCl/naloxone HCl 2mg/0.5mg oral capsules
Time frame: pk blood draws over a 72 hour period
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 23 Jun 2017.
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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.
Mark Leibowitz, MD principal investigator
CEDRA Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by NanoSHIFT LLC at 1 site in United States.
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 6 inclusion and 15 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 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
pharmacokinetic profile of an investigational formulation of buprenorphine HCl/naloxone HCl 2mg/0.5mg oral capsules (time frame: pk blood draws over a 72 hour period). 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 23 Jun 2017.