Healthy SubjectsPhase 1NCT01367496
Pharmacokinetics and Bioavailability of Single Subcutaneous Doses of Methylnaltrexone Versus Intravenous Dose
A Phase 1 study testing SC Methylnaltrexone (MNTX) and IV Methylnaltrexone (MNTX) in people with Healthy Subjects, run by Bausch Health Americas, Inc. at 1 site in United States.
Trial summary
This is an open-label, Phase I study. Study treatments will entail a four-way crossover among three single, ascending, subcutaneous doses and one intravenous dose of MNTX in six healthy normal male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- SC Methylnaltrexone (MNTX) and IV Methylnaltrexone (MNTX)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Aug 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject weight between 60 and 80 kg
- Subject a non-smoker
- Subject in good physical health, based on history, physical exam, appropriate laboratory and diagnostics tests at screening with no evidence of clinically significant chronic medical condition.
Who cannot join
- Subject with known hypersensitivity to methylnaltrexone, naltrexon or other opioids
- Subject consuming any prescription medication within the past two weeks, over-the-counter (OTC) products within seven days, any experimental medication within 30 days prior to study screening, or of any drug with a half-life longer then three days within 10 half-lives (>30 days) of screening
- Subject consuming barbiturates or other inducers or inhibitors of CYP450 within 3 months of screening
- Subject with history or evidence of cardiovascular, gastrointestinal, hepatic, neurological, pulmonary, and renal or other significant chronic illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Progenics Pharmaceuticals, Inc.
Tarrytown, New York, 10591
About this study
Official title: An Open-Label, Phase I Study of the Pharmacokinetics and Bioavailability of Single, Ascending Subcutaneous Doses of Methylnaltrexone Versus Intravenous Dose in Normal, Healthy Male Volunteers
This is an open-label, Phase I study. Study treatments will entail a four-way crossover among three single, ascending, subcutaneous doses and one intravenous dose of MNTX in six healthy normal male volunteers. Blood samples will be obtained to determine plasma pharmacokinetics, dose proportionality for subcutaneous doses, and absolute bioavailability versus an intravenous dose.
- Conditions
- Healthy Subjects
- Being tested
- SC Methylnaltrexone (MNTX), IV Methylnaltrexone (MNTX)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC Methylnaltrexone (MNTX)Drug
Dose 1
SC Methylnaltrexone (MNTX)Drug
Dose 2
SC Methylnaltrexone (MNTX)Drug
Dose 3
IV Methylnaltrexone (MNTX)Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: SC Methylnaltrexone (MNTX) |
| Arm 2 | Experimental | Not described Receives: Drug: SC Methylnaltrexone (MNTX) |
| Arm 3 | Experimental | Not described Receives: Drug: SC Methylnaltrexone (MNTX) |
| Arm 4 | Experimental | Not described Receives: Drug: IV Methylnaltrexone (MNTX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration of MNTX
The objective of this study is to determine the plasma pharmacokinetic of single, ascending, subcutaneous doses and a single intravenous dose of methylnaltrexone (MNTX) in normal healthy male subjects.
Measured: 32 days
Secondary outcomes (7)
Time to Maximum Plasma Concentration (Tmax) of MNTX
The objective of this study is to determine the plasma pharmacokinetic of single, ascending, subcutaneous doses and a single intravenous dose of methylnaltrexone (MNTX) in normal healthy male subjects.
Measured: 32 days
Clearance of MNTX
The objective of this study is to determine the plasma pharmacokinetic of single, ascending, subcutaneous doses and a single intravenous dose of methylnaltrexone (MNTX) in normal healthy male subjects.
Measured: 32 days
Half-live of MNTX
The objective of this study is to determine the plasma pharmacokinetic of single, ascending, subcutaneous doses and a single intravenous dose of methylnaltrexone (MNTX) in normal healthy male subjects.
Measured: 32 days
Volume of Distribution of MNTX
The objective of this study is to determine the plasma pharmacokinetic of single, ascending, subcutaneous doses and a single intravenous dose of methylnaltrexone (MNTX) in normal healthy male subjects.
Measured: 32 days
Area Under the Plasma Concentration versus Time Curve (AUC) of MNTX
The objective of this study is to determine the plasma pharmacokinetic of single, ascending, subcutaneous doses and a single intravenous dose of methylnaltrexone (MNTX) in normal healthy male subjects.
Measured: 32 days
Urinary Clearance of MNTX
The objective of this study is to determine the plasma pharmacokinetic of single, ascending, subcutaneous doses and a single intravenous dose of methylnaltrexone (MNTX) in normal healthy male subjects.
Measured: 32 days
Percentage of MNTX Excreted in Urine
The objective of this study is to determine the plasma pharmacokinetic of single, ascending, subcutaneous doses and a single intravenous dose of methylnaltrexone (MNTX) in normal healthy male subjects.
Measured: 32 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startJun 2002
- Primary completionAug 2002
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tage Ramakrishna, MD, Study director, Progenics Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367496
- Sponsor's protocol ID
- MNTX 103
- Status last verified
- Nov 2019
- First submitted
- 27 May 2011
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase I Study of the Pharmacokinetics and Bioavailability of Single, Ascending Subcutaneous Doses of Methylnaltrexone Versus Intravenous Dose in Normal, Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01367496
- Acronym / sponsor ID
- MNTX 103
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2002
- Primary completion
- Aug 2002 (actual)
- Study completion
- Aug 2002 (actual)
- First posted
- 7 Jun 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.
This is an open-label, Phase I study. Study treatments will entail a four-way crossover among three single, ascending, subcutaneous doses and one intravenous dose of MNTX in six healthy normal male volunteers. Blood samples will be obtained to determine plasma pharmacokinetics, dose proportionality for subcutaneous doses, and absolute bioavailability versus an intravenous dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: SC Methylnaltrexone (MNTX) |
| Arm 2 | Experimental | Drug: SC Methylnaltrexone (MNTX) |
| Arm 3 | Experimental | Drug: SC Methylnaltrexone (MNTX) |
| Arm 4 | Experimental | Drug: IV Methylnaltrexone (MNTX) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject weight between 60 and 80 kg
- Subject a non-smoker
- Subject in good physical health, based on history, physical exam, appropriate laboratory and diagnostics tests at screening with no evidence of clinically significant chronic medical condition.
Key exclusion criteria (4 listed)
- Subject with known hypersensitivity to methylnaltrexone, naltrexon or other opioids
- Subject consuming any prescription medication within the past two weeks, over-the-counter (OTC) products within seven days, any experimental medication within 30 days prior to study screening, or of any drug with a half-life longer then three days within 10 half-lives (>30 days) of screening
- Subject consuming barbiturates or other inducers or inhibitors of CYP450 within 3 months of screening
- Subject with history or evidence of cardiovascular, gastrointestinal, hepatic, neurological, pulmonary, and renal or other significant chronic illness.
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 |
|---|---|---|
| SC Methylnaltrexone (MNTX)Dose 1 | Drug | Arm 1 |
| SC Methylnaltrexone (MNTX)Dose 2 | Drug | Arm 2 |
| SC Methylnaltrexone (MNTX)Dose 3 | Drug | Arm 3 |
| IV Methylnaltrexone (MNTX) | Drug | Arm 4 |
Primary outcome
Peak Plasma Concentration of MNTX
Time frame: 32 days
The objective of this study is to determine the plasma pharmacokinetic of single, ascending, subcutaneous doses and a single intravenous dose of methylnaltrexone (MNTX) in normal healthy male subjects.
7 secondary outcomes
Time to Maximum Plasma Concentration (Tmax) of MNTX
Time frame: 32 days
Clearance of MNTX
Time frame: 32 days
Half-live of MNTX
Time frame: 32 days
Volume of Distribution of MNTX
Time frame: 32 days
Area Under the Plasma Concentration versus Time Curve (AUC) of MNTX
Time frame: 32 days
Urinary Clearance of MNTX
Time frame: 32 days
Percentage of MNTX Excreted in Urine
Time frame: 32 days
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 27 Nov 2019.
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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.
Tage Ramakrishna, MD study director
Progenics Pharmaceuticals, Inc.
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 SC Methylnaltrexone (MNTX) and IV Methylnaltrexone (MNTX) in people with Healthy Subjects, run by Bausch Health Americas, Inc. 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 3 inclusion and 4 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 27 Nov 2019. 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?
Peak Plasma Concentration of MNTX (time frame: 32 days). 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 27 Nov 2019.