Healthy Adult SubjectsPhase 1NCT01366378
Effect of Cimetidine on the Single-Dose PK of IV- Administered MNTX
A Phase 1 study testing methylnaltrexone in people with Healthy Adult Subjects, run by Bausch Health Americas, Inc. at 1 site in United States.
Trial summary
This open-label study assesses the single-dose pharmacokinetics of intravenously-administered MNTX in healthy adult male and female subjects in the absence of, and in the presence of, orally-administered cimetidine. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- methylnaltrexone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Feb 2007
- 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 males and females between the ages of 18 and 45
- Subjects who are non-smokers
- Subjects with body weights with range of 154-220 lbs.
Who cannot join
- Females who are pregnant or lactating
- Subjects with a history of any clinically significant disease or condition affecting a major organ system
- Subjects with ECG abnormalities
- Subjects who have tested positive for hepatitis B, hepatitis C or HIV
- Subjects who have had a diagnosis of alcohol or substance dependence with the past 12 months
- Subjects with positive urine results for drugs of abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Progenics Pharmaceuticals, Inc.
Tarrytown, New York, 10591
About this study
Official title: A Phase 1, Open-Label, Study of the Effect of Cimetidine, a Known Inhibitor of Active Renal Secretion, on the Single-Dose Pharmacokinetics of Intravenously-Administered Methylnaltrexone in Healthy Adults
This open-label study assesses the single-dose pharmacokinetics of intravenously-administered MNTX in healthy adult male and female subjects in the absence of, and in the presence of, orally-administered cimetidine.
- Conditions
- Healthy Adult Subjects
- Being tested
- methylnaltrexone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylnaltrexoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | methylnaltrexone (MNTX) Receives: Drug: methylnaltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax) of MNTX prior to and following multi-dose cimetidine regimen
To assess the potential effects of cimetidine on the pharmacokinetics of MNTX
Measured: 7 days
Secondary outcomes (5)
Area under the plasma concentration (AUC) of MNTX prior to and following a multi-dose cimetidine regimen
To assess the potential effects of cimetidine on the pharmacokinetics of MNTX
Measured: 7 days
Half-life of MNTX prior to and following a multi-dose cimetidine regimen
To assess the potential effects of cimetidine on the pharmacokinetics of MNTX
Measured: 7 days
Clearance (both total and renal)of MNTX prior to and following a multi-dose cimetidine regimen
To assess the potential effects of cimetidine on the pharmacokinetics of MNTX
Measured: 7 days
Volume of distribution of MNTX prior to and following a multi-dose cimetidine regimen
To assess the potential effects of cimetidine on the pharmacokinetics of MNTX
Measured: 7 days
Number of subject with adverse events as measured before, during, and after administration of cimetidine
To assess the potential effects of cimetidine on safety, and tolerability of MNTX
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startJan 2007
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult 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
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT01366378
- Sponsor's protocol ID
- MNTX 1304
- 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 1, Open-Label, Study of the Effect of Cimetidine, a Known Inhibitor of Active Renal Secretion, on the Single-Dose Pharmacokinetics of Intravenously-Administered Methylnaltrexone in Healthy Adults
- ClinicalTrials.gov ID
- NCT01366378
- Acronym / sponsor ID
- MNTX 1304
- Conditions
- Healthy Adult Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 6 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 open-label study assesses the single-dose pharmacokinetics of intravenously-administered MNTX in healthy adult male and female subjects in the absence of, and in the presence of, orally-administered cimetidine.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: methylnaltrexonemethylnaltrexone (MNTX) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males and females between the ages of 18 and 45
- Subjects who are non-smokers
- Subjects with body weights with range of 154-220 lbs.
Key exclusion criteria (6 listed)
- Females who are pregnant or lactating
- Subjects with a history of any clinically significant disease or condition affecting a major organ system
- Subjects with ECG abnormalities
- Subjects who have tested positive for hepatitis B, hepatitis C or HIV
- Subjects who have had a diagnosis of alcohol or substance dependence with the past 12 months
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 | Drug | Arm 1 |
Primary outcome
Peak plasma concentration (Cmax) of MNTX prior to and following multi-dose cimetidine regimen
Time frame: 7 days
To assess the potential effects of cimetidine on the pharmacokinetics of MNTX
5 secondary outcomes
Area under the plasma concentration (AUC) of MNTX prior to and following a multi-dose cimetidine regimen
Time frame: 7 days
Half-life of MNTX prior to and following a multi-dose cimetidine regimen
Time frame: 7 days
Clearance (both total and renal)of MNTX prior to and following a multi-dose cimetidine regimen
Time frame: 7 days
Volume of distribution of MNTX prior to and following a multi-dose cimetidine regimen
Time frame: 7 days
Number of subject with adverse events as measured before, during, and after administration of cimetidine
Time frame: 7 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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Healthy Subjects
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 in people with Healthy Adult 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 6 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 (Cmax) of MNTX prior to and following multi-dose cimetidine regimen (time frame: 7 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.