Healthy VolunteersPhase 1NCT01363323
Effect of Methylnaltrexone (MNTX) on Electrocardiogram (ECG) Parameters and Cardiac Repolarization
A Phase 1 study testing Methylnaltrexone (MNTX) and Moxifloxacin in people with Healthy Volunteers, run by Bausch Health Americas, Inc. at 1 site in United States.
Trial summary
This study will employ a single-center, randomized, double-blind parallel-group design for MNTX and placebo, with a positive control (moxifloxacin) dosed single-blind to confirm methodology, in normal healthy male and female volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Methylnaltrexone (MNTX) and Moxifloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 546 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Feb 2005
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy and free of acute active illnesses
- Males and females between the ages of 18 and 45 years, inclusive
- Body mass index between 18-30, inclusive, and weight between 50-110 kgs
- ECG within normal limits (including PR <220, QRS <110, and QTc <450 ms.)
Who cannot join
- Previous MNTX exposure
- Currently pregnant or nursing
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, or other medically significant disorders
- Consumption of alcoholic beverages within 7 days prior to study confinement
- Any evidence of congenital or familial long-QT syndrome
- History of drug abuse of positive findings on urine drug screen
- Known allergy or hypersensitivity to MNTX or its excipients, moxifloxacin, opioids, or related drugs or a history or relevant adverse drug reactions of any origin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Progenics Pharmaceuticals
Tarrytown, New York, 10591
About this study
Official title: A Randomized, Double-Blind, Placebo/Positive Controlled, Evaluation of the Effects of MNTX on ECG Parameters and Cardiac Repolarization in Normal Volunteers
This study will employ a single-center, randomized, double-blind parallel-group design for MNTX and placebo, with a positive control (moxifloxacin) dosed single-blind to confirm methodology, in normal healthy male and female volunteers. Multiple ECGs will be obtained after single clinical and supratherapeutic doses of MNTX to assess ECG effects compared to placebo.
- Conditions
- Healthy Volunteers
- Being tested
- Methylnaltrexone (MNTX), Placebo, Moxifloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylnaltrexone (MNTX)Drug
Dose 1
Methylnaltrexone (MNTX)Drug
Dose 2
Methylnaltrexone (MNTX)Drug
Dose 3
PlaceboDrug
MoxifloxacinDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Methylnaltrexone (MNTX) |
| Arm 2 | Experimental | Not described Receives: Drug: Methylnaltrexone (MNTX) |
| Arm 3 | Experimental | Not described Receives: Drug: Methylnaltrexone (MNTX) |
| Arm 4 | Placebo comparator | Not described Receives: Drug: Placebo |
| Arm 5 | Active comparator | Not described Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of MNTX on QTcI duration
The primary objective of the study is to compare the effects of clinical and supratherapeutic doses of MNTX with the effects of placebo on QTcI duration in healthy volunteers.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startNov 2004
- Primary completionJan 2005
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 546 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
- NCT01363323
- Sponsor's protocol ID
- MNTX 1106
- Status last verified
- Nov 2019
- First submitted
- 27 May 2011
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo/Positive Controlled, Evaluation of the Effects of MNTX on ECG Parameters and Cardiac Repolarization in Normal Volunteers
- ClinicalTrials.gov ID
- NCT01363323
- Acronym / sponsor ID
- MNTX 1106
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 546 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 1 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 will employ a single-center, randomized, double-blind parallel-group design for MNTX and placebo, with a positive control (moxifloxacin) dosed single-blind to confirm methodology, in normal healthy male and female volunteers. Multiple ECGs will be obtained after single clinical and supratherapeutic doses of MNTX to assess ECG effects compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Methylnaltrexone (MNTX) |
| Arm 2 | Experimental | Drug: Methylnaltrexone (MNTX) |
| Arm 3 | Experimental | Drug: Methylnaltrexone (MNTX) |
| Arm 4 | Placebo comparator | Drug: Placebo |
| Arm 5 | Active comparator | Drug: Moxifloxacin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy and free of acute active illnesses
- Males and females between the ages of 18 and 45 years, inclusive
- Body mass index between 18-30, inclusive, and weight between 50-110 kgs
- ECG within normal limits (including PR <220, QRS <110, and QTc <450 ms.)
Key exclusion criteria (7 listed)
- Previous MNTX exposure
- Currently pregnant or nursing
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, or other medically significant disorders
- Consumption of alcoholic beverages within 7 days prior to study confinement
- Any evidence of congenital or familial long-QT syndrome
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 |
|---|---|---|
| Methylnaltrexone (MNTX)Dose 1 | Drug | Arm 1 |
| Methylnaltrexone (MNTX)Dose 2 | Drug | Arm 2 |
| Methylnaltrexone (MNTX)Dose 3 | Drug | Arm 3 |
| Placebo | Drug | Arm 4 |
| Moxifloxacin | Drug | Arm 5 |
Primary outcome
Effects of MNTX on QTcI duration
Time frame: 3 days
The primary objective of the study is to compare the effects of clinical and supratherapeutic doses of MNTX with the effects of placebo on QTcI duration in healthy volunteers.
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 29 Nov 2019.
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Screening Protocol
Pain
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 Methylnaltrexone (MNTX) and Moxifloxacin in people with Healthy Volunteers, 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 7 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 29 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?
Effects of MNTX on QTcI duration (time frame: 3 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 29 Nov 2019.