Normal Healthy Volunteers Will be Treated With Lofexidine to Understand the Absolute Bioavailability and Mass Balance Recovery of the ProductPhase 1NCT01310296

Lofexidine ADME & Mass Balance in Volunteers

A Phase 1 study testing Lofexidine hydrochloride in people with Normal Healthy Volunteers Will be Treated With Lofexidine to Understand the Absolute Bioavailability and Mass Balance Recovery of the Product, run by USWM, LLC (dba US WorldMeds) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is 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. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Normal Healthy Volunteers Will be Treated With Lofexidine to Understand the Absolute Bioavailability and Mass Balance Recovery of the Product
What is being tested?: Lofexidine hydrochloride
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Jul 2011to Aug 2011
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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subject must be a male or non-pregnant, non-breastfeeding female.
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).
Female subjects must agree to use one of the following forms of birth control from screening until 14 days after completion of the study:
Vasectomized partner (at least 6 months prior to dosing)
Post-menopausal (at least 2 years prior to dosing)

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Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) at least 6 months prior to dosing
Double barrier (diaphragm with spermicide; condoms with spermicide)
IUD (intra-uterine device)
Abstinence (must agree to use a double barrier method if they become sexually active during the study)
Implanted or intrauterine hormonal contraceptives in use for at least 6 consecutive months prior to study dosing and throughout the study duration
Oral, patch, and injected contraceptives or vaginal hormonal device (i.e. NuvaRing®) in use for at least 3 consecutive months prior to study dosing and throughout the study duration.
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; diastolic BP: 50-90 mmHg, and oral temperature within the normal range of 35.6-37.7° C. 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.
For the study period in which the subject is assigned to receive Treatment A (lofexidine oral solution containing 14C-lofexidine), subject must be:
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.
Willing to remain in the clinical research center for a minimum of 7 consecutive days during pre-dose, dose, and post-dose evaluation periods. Subjects must be willing to stay for an additional 24 to 48 hours if necessary.
Willing to collect all urine and fecal samples for the duration of the study period as required.

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 radiolabeled clinical trial within the last 12 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, except hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication.
Subjects that have discontinued the use of implanted, intrauterine, or injected hormonal contraceptives must not have used any for 6 months prior to study start.
Subjects that have discontinued the use of oral, patch, or vaginal hormonal contraceptives must not have used any for 1 month prior to study start.
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.
Is a female with a positive pregnancy test result.
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 QTcB greater than 450 msec (males) or greater than 470 msec (females), at screening obtained after 5 minutes rest in a supine position using the ECG machine algorithm.
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.

United States1 site

Worldwide Clinical Trials
San Antonio, Texas, 78217

Other trials in United States

About this study

Official title: 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

The purpose of this study is 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.

Conditions: Normal Healthy Volunteers Will be Treated With Lofexidine to Understand the Absolute Bioavailability and Mass Balance Recovery of the Product
Being tested: Lofexidine hydrochloride
Keywords: Phase 1, Normal Healthy Volunteers, Mass Balance, ADME, Absolute Bioavailability

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
Lofexidine hydrochlorideDrug
Single Dose = 200 μg lofexidine in phosphate-buffered saline administered intravenously via infusion pump at a rate of 1 μg/min for 200 min

Study groups in NCT01310296
Study group	Role	What they receive
Radiolabeled Lofexidine Oral Solution	Other	Participants will receive a radiolabeled lofexidine oral solution followed by safety evaluations, and plasma, urine and fecal sampling for up to 216 hours post dose. Receives: Drug: Lofexidine hydrochloride
Lofexidine Intravenous Solution	Experimental	Participants will receive 200 mcg of lofexidine in an intravenous solution infusion over 200 minutes followed by 72 hours of safety evaluation and plasma sampling. Receives: Drug: Lofexidine hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

Mass Balance
To determine the mass balance recovery of orally administered lofexidine hydrochloride
Measured: plasma, urine, and fecal samples up to 216 hours post dose

Secondary outcomes (1)

Absolute Bioavailability & Tolerability
- To determine the absolute bioavailability of a single oral dose of lofexidine compared to a single intravenous dose of lofexidine
- To determine the tolerability of lofexidine oral solution and intravenous lofexidine
Measured: plasma samples over 72 and 144 hrs post-dose for IV and oral doses, respectively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Aug 2011

First posted8 Mar 2011 (estimated)
Study startJul 2011
Primary completionAug 2011
Study completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Normal Healthy Volunteers Will be Treated With Lofexidine to Understand the Absolute Bioavailability and Mass Balance Recovery of the ProductStudies 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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01310296
Sponsor's protocol ID: USWM-LX1-1003/ 02749MZ
Status last verified: Oct 2017
First submitted: 4 Mar 2011
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, 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
ClinicalTrials.gov ID: NCT01310296
Acronym / sponsor ID: USWM-LX1-1003/ 02749MZ
Conditions: Normal Healthy Volunteers Will be Treated With Lofexidine to Understand the Absolute Bioavailability and Mass Balance Recovery of the Product
Keywords: Phase 1, Normal Healthy Volunteers, Mass Balance, ADME, Absolute Bioavailability
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: USWM, LLC (dba US WorldMeds)Industry (pharma, biotech, devices)
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Jul 2011
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 8 Mar 2011 (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 determine the mass balance and absolute bioavailability of a single oral dose of 14C-labeled lofexidine compared to a single intravenous dose of lofexidine.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Radiolabeled Lofexidine Oral Solution	Other	Drug: Lofexidine hydrochlorideParticipants will receive a radiolabeled lofexidine oral solution followed by safety evaluations, and plasma, urine and fecal sampling for up to 216 hours post dose.
Lofexidine Intravenous Solution	Experimental	Drug: Lofexidine hydrochlorideParticipants will receive 200 mcg of lofexidine in an intravenous solution infusion over 200 minutes followed by 72 hours of safety evaluation and plasma sampling.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (19 listed)

Subject must be a male or non-pregnant, non-breastfeeding female.
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).
Female subjects must agree to use one of the following forms of birth control from screening until 14 days after completion of the study:
Vasectomized partner (at least 6 months prior to dosing)

Key exclusion criteria (23 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	Radiolabeled Lofexidine Oral Solution
Lofexidine hydrochlorideSingle Dose = 200 μg lofexidine in phosphate-buffered saline administered intravenously via infusion pump at a rate of 1 μg/min for 200 min	Drug	Lofexidine Intravenous Solution

Primary outcome

Mass Balance
Time frame: plasma, urine, and fecal samples up to 216 hours post dose
To determine the mass balance recovery of orally administered lofexidine hydrochloride

1 secondary outcome

Absolute Bioavailability & Tolerability
Time frame: plasma samples over 72 and 144 hrs post-dose for IV and oral doses, respectively

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.

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?

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 19 inclusion and 23 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?

On the ClinicalTrials.gov record for NCT01310296.

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.