Normal Healthy VolunteersPhase 1NCT01629446
Lofexidine Mass Balance in Volunteers
A Phase 1 study testing Lofexidine hydrochloride in people with Normal Healthy Volunteers, run by USWM, LLC (dba US WorldMeds) at 1 site in United States.
Trial summary
The purpose of this study is to see how lofexidine (investigational study formulation drug) is absorbed, broken down, and removed from the body. To do this, a special form of the study drug will be used that has a radioactive carbon atom attached. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Normal Healthy Volunteers
- What is being tested?
- Lofexidine hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jun 2012
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject must be a male
- Subject must be between 18 and 50 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).
- 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 each confinement period.
- Subject's vital signs must be within the following ranges to be included: Vital signs measured sitting after 3 minutes rest; heart rate: 50-90 bpm; systolic BP: 100-140 mmHg; and diastolic BP: 50-90 mmHg. Out-of-range vital signs may be repeated once. Predose vital signs will be assessed by the Principal Investigator or designee (e.g., a medically qualified sub-investigator) prior to study drug administration. The Principal Investigator or designee will verify the eligibility of each subject with out-of-range vital signs and document approval prior to dosing.
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- Subject is willing to eat entire meals and snacks provided during confinement at the research facility; and understand that the diet will include foods with high fiber content and possibly prune juice.
- Subject is willing to remain in the clinical research center for a minimum of 7 consecutive days during pre-dose, dose, and post-dose evaluation periods.
- Subject is willing to collect all urine and fecal samples for the duration of the study period as required.
- Subject is willing to use a waterless commode located in a designated dry room for urine and feces collection for the duration of the study period as required.
- Subject is willing to abstain from showering for the first 72 to 96 hours following dose administration. After the restriction from showering is lifted, subject must be willing to provide a urine sample prior to showering for the remainder of the confinement period.
Who cannot join
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, 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 of any syncopal episode or seizures.
- Presence of acute disease state (eg, nausea, vomiting, fever, diarrhea) within 7 days prior to scheduled dose administration.
- History or presence of allergic or adverse response to lofexidine or related drugs.
- Has been on a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
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- Has donated blood or plasma within 30 days prior to the first dose of study medication.
- Has participated in a standard radiolabeled clinical trial within the last 12 months prior to the first dose of study medication or a micro tracer clinical trial within the last 3 months prior to the first dose of study medication.
- Has participated in another clinical trial (randomized subjects only) within 30 days prior to the first dose of study medication.
- 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 within 14 days prior to the first dose of study medication.
- Has been treated with any known drugs that are moderate or strong inhibitors/inducers of CYP enzymes such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication and that in the Investigator's judgment may impact subject safety or the validity of the study results.
- Has smoked or used tobacco products within 60 days prior to the first dose of study medication.
- Has any prior history of substance abuse or treatment (including alcohol) within the past 2 years.
- Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates).
- Has had a positive test for, or has been treated for hepatitis B, hepatitis C, or Human Immunodeficiency Virus (HIV).
- Has orthostatic hypotension at screening defined as a drop in systolic blood pressure ≥ 20 mmHg or a fall in diastolic blood pressure ≥ 10 mmHg following a 2 minute stand. Out-of-range vital signs may be repeated once. Predose vital signs will be assessed by the Principal Investigator or designee (e.g., a medically qualified sub-investigator) prior to study drug administration. The Principal Investigator or designee will verify the eligibility of each subject with out-of-range vital signs and document approval prior to dosing.
- Subjects with a QTcF greater than 450 msec at screening obtained after 5 minutes rest in a supine position using the ECG machine algorithm. The ECGs may be repeated as appropriate in order to confirm values and rule out extraneous results.
- Has irregular bowel habits. ("Irregular" being defined for the purpose of this study as NOT having a bowel movement at least every 2 days.)
- Has been exposed to radiation, including dental or medical imaging such as x ray or tomography, in the 6 months prior to dose administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Open-Label, Single-Period, Single-Treatment Study to Determine the Mass Balance of a Single Oral Dose of 14C Labeled Lofexidine
The purpose of this study is to see how lofexidine (investigational study formulation drug) is absorbed, broken down, and removed from the body. To do this, a special form of the study drug will be used that has a radioactive carbon atom attached. Blood, urine, and feces samples will be collected at different times to measure the amount of the study drug and radioactivity they contain. The amount of radioactivity you will be exposed to is less than the amount of radiation from a regular X-ray.
Read the detailed description
The purpose of this study is to determine the mass balance of a single oral dose of 14C labeled lofexidine. Study US WorldMeds Reference Number USWM-LX1-1003, conducted in July and August of 2011, was a single-center, open-label, two-period, two-treatment, randomized sequence study to determine the mass balance and absolute bioavailability of a single oral dose of 14C-labeled lofexidine compared to a single intravenous dose of lofexidine. During the conduct of the study, deficiencies occurred in the collection and processing of urine samples from subjects administered the oral dose of 14C-labeled lofexidine. In study USWM-LX1-1003-1, six male subjects will be dosed with 14C labeled lofexidine oral solution in order to provide accurate data for the mass balance portion of the study. Male subjects who successfully participated in and completed study USWM-LX1-1003 will be enrolled first. Additional male subjects will be enrolled as needed to provide a cohort of 6 subjects. Additional provisions to ensure adequate urine collections have now been implemented at the site and will be utilized in USWM-LX1-1003-1. All blood draws for pharmacokinetic analysis and radioanalysis, and all urine and fecal collection intervals, will occur at the same time points in USWM-LX1-1003-1 as they did in USWM-LX1-1003.
To study the absorption, distribution, metabolism, and elimination (ADME), trace amounts of 14C compounds are quantified using accelerator mass spectrometry (AMS). As a form of an isotope ratio atom counter that achieves the lowest detection limits of any type of mass spectrometry, AMS provides quantitative sensitivity towards 14C labeled compounds to low attomole (10-18) levels. This high degree of sensitivity enables the detection of compounds in very small specimens and/or tissues after administration of doses that can be both chemically and radiochemically small (microdose levels).
At the radioactive dose to be given (approximately 280 nCi; 10.36 kBq) the total radiation exposure to the participant is within the level of background radiation exposure that occurs naturally and orders of magnitude (1000 fold reduction on average) below the levels typical for human metabolism studies using 14C tracers.
- Conditions
- Normal Healthy Volunteers
- Being tested
- Lofexidine hydrochloride
- Keywords
- Phase 1, Normal healthy volunteers, Mass Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lofexidine hydrochlorideDrug
Single Dose = Solution containing 400 μg lofexidine HCl and a tracer amount of 14C lofexidine
| Study group | Role | What they receive |
|---|---|---|
| Lofexidine HCl with 14C tracer | Experimental | Not described Receives: Drug: Lofexidine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass Balance
To study the absorption, distribution, metabolism, and elimination (ADME), trace amounts of 14C compounds are quantified using accelerator mass spectrometry (AMS). As a form of an isotope ratio atom counter that achieves the lowest detection limits of any type of mass spectrometry, AMS provides quantitative sensitivity towards 14C labeled compounds to low attomole (10-18) levels. This high degree of sensitivity enables the detection of compounds in very small specimens and/or tissues after administration of doses that can be both chemically and radiochemically small (microdose levels).
Measured: plasma, urine, and fecal samples up to 216 hours post dose
Secondary outcomes (1)
tolerability of lofexidine oral solution
To determine the tolerability of lofexidine oral solution, plasma samples will be collected over 144s period post dose. Plasma samples will be collected for possibly pharmacokinetic analysis; radioanalysis samples will be analyzed for combined lofexidine and metabolites using a validated analytical method.
Measured: plasma samples over 144 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Healthy VolunteersStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- USWM, LLC (dba US WorldMeds)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- James A Longstreth, PhD, Principal investigator, US WorldMedsCharles W Gorodetzky, MD, PhD, Principal investigator, US WorldMedsMark Leibowitz, MD, Principal investigator, Worldwide Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629446
- Sponsor's protocol ID
- USWM-LX1-1003-1
- Other IDs
- 1R01DA030916-01
- Status last verified
- Oct 2017
- First submitted
- 14 Jun 2012
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Single-Period, Single-Treatment Study to Determine the Mass Balance of a Single Oral Dose of 14C Labeled Lofexidine
- ClinicalTrials.gov ID
- NCT01629446
- Acronym / sponsor ID
- USWM-LX1-1003-1
- Conditions
- Normal Healthy Volunteers
- Keywords
- Phase 1, Normal healthy volunteers, Mass Balance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- USWM, LLC (dba US WorldMeds)Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 27 Jun 2012 (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 this study is to see how lofexidine (investigational study formulation drug) is absorbed, broken down, and removed from the body. To do this, a special form of the study drug will be used that has a radioactive carbon atom attached. Blood, urine, and feces samples will be collected at different times to measure the amount of the study drug and radioactivity they contain. The amount of radioactivity you will be exposed to is less than the amount of radiation from a regular X-ray.
Detailed description
The purpose of this study is to determine the mass balance of a single oral dose of 14C labeled lofexidine. Study US WorldMeds Reference Number USWM-LX1-1003, conducted in July and August of 2011, was a single-center, open-label, two-period, two-treatment, randomized sequence study to determine the mass balance and absolute bioavailability of a single oral dose of 14C-labeled lofexidine compared to a single intravenous dose of lofexidine. During the conduct of the study, deficiencies occurred in the collection and processing of urine samples from subjects administered the oral dose of 14C-labeled lofexidine. In study USWM-LX1-1003-1, six male subjects will be dosed with 14C labeled lofexidine oral solution in order to provide accurate data for the mass balance portion of the study. Male subjects who successfully participated in and completed study USWM-LX1-1003 will be enrolled first. Additional male subjects will be enrolled as needed to provide a cohort of 6 subjects. Additional provisions to ensure adequate urine collections have now been implemented at the site and will be utilized in USWM-LX1-1003-1. All blood draws for pharmacokinetic analysis and radioanalysis, and all urine and fecal collection intervals, will occur at the same time points in USWM-LX1-1003-1 as they did in USWM-LX1-1003.
To study the absorption, distribution, metabolism, and elimination (ADME), trace amounts of 14C compounds are quantified using accelerator mass spectrometry (AMS). As a form of an isotope ratio atom counter that achieves the lowest detection limits of any type of mass spectrometry, AMS provides quantitative sensitivity towards 14C labeled compounds to low attomole (10-18) levels. This high degree of sensitivity enables the detection of compounds in very small specimens and/or tissues after administration of doses that can be both chemically and radiochemically small (microdose levels).
At the radioactive dose to be given (approximately 280 nCi; 10.36 kBq) the total radiation exposure to the participant is within the level of background radiation exposure that occurs naturally and orders of magnitude (1000 fold reduction on average) below the levels typical for human metabolism studies using 14C tracers.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lofexidine HCl with 14C tracer | Experimental | Drug: Lofexidine hydrochloride |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Subject must be a male
- Subject must be between 18 and 50 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).
- 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 each confinement period.
Key exclusion criteria (20 listed)
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, 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 of any syncopal episode or seizures.
- Presence of acute disease state (eg, nausea, vomiting, fever, diarrhea) within 7 days prior to scheduled dose administration.
- History or presence of allergic or adverse response to lofexidine or related drugs.
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 |
|---|---|---|
| Lofexidine hydrochlorideSingle Dose = Solution containing 400 μg lofexidine HCl and a tracer amount of 14C lofexidine | Drug | Lofexidine HCl with 14C tracer |
Primary outcome
Mass Balance
Time frame: plasma, urine, and fecal samples up to 216 hours post dose
To study the absorption, distribution, metabolism, and elimination (ADME), trace amounts of 14C compounds are quantified using accelerator mass spectrometry (AMS). As a form of an isotope ratio atom counter that achieves the lowest detection limits of any type of mass spectrometry, AMS provides quantitative sensitivity towards 14C labeled compounds to low attomole (10-18) levels. This high degree of sensitivity enables the detection of compounds in very small specimens and/or tissues after administration of doses that can be both chemically and radiochemically small (microdose levels).
1 secondary outcome
tolerability of lofexidine oral solution
Time frame: plasma samples over 144 hours post dose
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 26 Oct 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.
James A Longstreth, PhD principal investigator
US WorldMeds
Charles W Gorodetzky, MD, PhD principal investigator
US WorldMeds
Mark Leibowitz, MD principal investigator
Worldwide Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lofexidine hydrochloride in people with Normal Healthy Volunteers, run by USWM, LLC (dba US WorldMeds) 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 11 inclusion and 20 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 26 Oct 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.
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?
Mass Balance (time frame: plasma, urine, and fecal samples up to 216 hours post dose). 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 26 Oct 2017.