Healthy AdultsPhase 1NCT01367535
Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan
A Phase 1 study testing SC Methylnaltrexone (MNTX), IV Methylnaltrexone (MNTX) and Oral Paroxetine in people with Healthy Adults, run by Bausch Health Americas, Inc. at 1 site in United States.
Trial summary
This study is a single-center, randomized, open-label, active and placebo-controlled, parallel-group, conducted in healthy male volunteers who have been shown to be extensive metabolizers of dextromethorphan. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- SC Methylnaltrexone (MNTX), IV Methylnaltrexone (MNTX) and Oral Paroxetine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Aug 2006
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males between the ages of 18 and 55
- Non-Smokers
- Body weight range form 154-220 lbs
- No history of clinically significant metabolic disorders.
Who cannot join
- Any history of low CYP450 2D6 activity
- History of alcohol abuse or recreational drugs
- History of any clinically significant disease or condition affecting a major organ system
- Donation or loss of blood, 60 days proceeding to screening visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Progenics Pharmaceuticals
Tarrytown, New York, 10591
About this study
Official title: A Phase I, Randomized, Open-Label, Active- and Placebo-Controlled Parallel Group Study of the Effect of Subcutaneous and Intravenous Methylnaltrexone on CYP450 2D6 Activity in Healthy Extensive Metabolizers of Dextromethorphan
This study is a single-center, randomized, open-label, active and placebo-controlled, parallel-group, conducted in healthy male volunteers who have been shown to be extensive metabolizers of dextromethorphan.
- Conditions
- Healthy Adults
- Being tested
- SC Methylnaltrexone (MNTX), IV Methylnaltrexone (MNTX), Oral Paroxetine, SC Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC Methylnaltrexone (MNTX)Drug
IV Methylnaltrexone (MNTX)Drug
Oral ParoxetineDrug
SC PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: SC Methylnaltrexone (MNTX) |
| Arm 2 | Experimental | Not described Receives: Drug: IV Methylnaltrexone (MNTX) |
| Arm 3 | Active comparator | Not described Receives: Drug: Oral Paroxetine |
| Arm 4 | Placebo comparator | Not described Receives: Drug: SC Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentration of MNTX
The objective of this study is to assess the effect of SC or IV doses of MNTX on CYP450 2D6 activity.
Measured: 4 months
Secondary outcomes (1)
Plasma Concentration of Paroxetine
The objective of this study is to assess the effect of SC or IV doses of MNTX on CYP450 2D6 activity.
Measured: 4 months
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 startMar 2006
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 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
- NCT01367535
- Sponsor's protocol ID
- MNTX 1108
- 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
- A Phase I, Randomized, Open-Label, Active- and Placebo-Controlled Parallel Group Study of the Effect of Subcutaneous and Intravenous Methylnaltrexone on CYP450 2D6 Activity in Healthy Extensive Metabolizers of Dextromethorphan
- ClinicalTrials.gov ID
- NCT01367535
- Acronym / sponsor ID
- MNTX 1108
- Conditions
- Healthy Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (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 study is a single-center, randomized, open-label, active and placebo-controlled, parallel-group, conducted in healthy male volunteers who have been shown to be extensive metabolizers of dextromethorphan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: SC Methylnaltrexone (MNTX) |
| Arm 2 | Experimental | Drug: IV Methylnaltrexone (MNTX) |
| Arm 3 | Active comparator | Drug: Oral Paroxetine |
| Arm 4 | Placebo comparator | Drug: SC Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males between the ages of 18 and 55
- Non-Smokers
- Body weight range form 154-220 lbs
- No history of clinically significant metabolic disorders.
Key exclusion criteria (4 listed)
- Any history of low CYP450 2D6 activity
- History of alcohol abuse or recreational drugs
- History of any clinically significant disease or condition affecting a major organ system
- Donation or loss of blood, 60 days proceeding to screening visit.
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) | Drug | Arm 1 |
| IV Methylnaltrexone (MNTX) | Drug | Arm 2 |
| Oral Paroxetine | Drug | Arm 3 |
| SC Placebo | Drug | Arm 4 |
Primary outcome
Plasma Concentration of MNTX
Time frame: 4 months
The objective of this study is to assess the effect of SC or IV doses of MNTX on CYP450 2D6 activity.
1 secondary outcome
Plasma Concentration of Paroxetine
Time frame: 4 months
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), IV Methylnaltrexone (MNTX) and Oral Paroxetine in people with Healthy Adults, 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 4 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. Some participants in this study may receive a placebo. 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?
Plasma Concentration of MNTX (time frame: 4 months). 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.