Healthy Adult SubjectsPhase 1NCT01366326
Evaluate the Pharmacokinetics (PK) of Methylnaltrexone (MNTX) in Healthy Adult Subjects
A Phase 1 study testing Methylnaltrexone bromide in people with Healthy Adult Subjects, run by Bausch Health Americas, Inc. at 1 site in United States.
Trial summary
MNTX 1109 is a single center, open label study, composed of normal healthy adult subjects to evaluate the PK of MNTX and its metabolites administered once daily as a subcutaneous (SC) injection for a period of seven days. Blood samples will be obtained at screening and for drug concentration data. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- Methylnaltrexone bromide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Aug 2010
- 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
- Body weight ≥40 kg (88 lb)
- In good health with no clinically significant abnormal findings on the physical examination, medical history or the screening 12-lead ECG
- Non-smoker
- Has no known allergies to study drug or other related chemically-related compounds (i.e. naltrexone, naloxone).
Who cannot join
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease
- History of clinically significant allergies
- Positive urine screen for drugs
- History of positive blood screen for human immunodeficiency virus (HIV), hepatitis B virus (Hep B), or hepatitis C virus (HCV)
- Prior exposure, allergy or known hypersensitivity to methylnaltrexone
- Diagnosis of alcohol or substance dependence within the past 12 months.
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 Multiple-Dose, Open-Label Study to Evaluate the Pharmacokinetics of MNTX in Healthy Adult Subjects
MNTX 1109 is a single center, open label study, composed of normal healthy adult subjects to evaluate the PK of MNTX and its metabolites administered once daily as a subcutaneous (SC) injection for a period of seven days. Blood samples will be obtained at screening and for drug concentration data.
- Conditions
- Healthy Adult Subjects
- Being tested
- Methylnaltrexone bromide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylnaltrexone bromideDrug
Subcutaneous MNTX
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Methylnaltrexone bromide Receives: Drug: Methylnaltrexone bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax) of MNTX and its Metabolites
To evaluate the PK profile of MNTX and its metabolites when administered as a SC injection once daily for seven days in healthy adult subjects.
Measured: 7 days
Secondary outcomes (2)
Peak Time of Maximum Concentration (Tmax) of MNTX and its Metabolites
To evaluate the PK profile of MNTX and its metabolites when administered as a SC injection once daily for seven days in healthy adult subjects.
Measured: 7 Days
Area Under the Plasma Concentration versus Time Curve (AUC) of MNTX and its Metabolites.
To evaluate the PK profile of MNTX and its metabolites when administered as a SC injection once daily for seven days in healthy adult subjects.
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 startJul 2010
- Primary completionAug 2010
- Study completionAug 2010
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tage Ramakrishna, MD, Study director, Progenics Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366326
- Sponsor's protocol ID
- MNTX 1109
- 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 Multiple-Dose, Open-Label Study to Evaluate the Pharmacokinetics of MNTX in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01366326
- Acronym / sponsor ID
- MNTX 1109
- Conditions
- Healthy Adult Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (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.
MNTX 1109 is a single center, open label study, composed of normal healthy adult subjects to evaluate the PK of MNTX and its metabolites administered once daily as a subcutaneous (SC) injection for a period of seven days. Blood samples will be obtained at screening and for drug concentration data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Methylnaltrexone bromideMethylnaltrexone bromide |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body weight ≥40 kg (88 lb)
- In good health with no clinically significant abnormal findings on the physical examination, medical history or the screening 12-lead ECG
- Non-smoker
- Has no known allergies to study drug or other related chemically-related compounds (i.e. naltrexone, naloxone).
Key exclusion criteria (6 listed)
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease
- History of clinically significant allergies
- Positive urine screen for drugs
- History of positive blood screen for human immunodeficiency virus (HIV), hepatitis B virus (Hep B), or hepatitis C virus (HCV)
- Prior exposure, allergy or known hypersensitivity to methylnaltrexone
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 bromideSubcutaneous MNTX | Drug | Arm 1 |
Primary outcome
Peak Plasma Concentration (Cmax) of MNTX and its Metabolites
Time frame: 7 days
To evaluate the PK profile of MNTX and its metabolites when administered as a SC injection once daily for seven days in healthy adult subjects.
2 secondary outcomes
Peak Time of Maximum Concentration (Tmax) of MNTX and its Metabolites
Time frame: 7 Days
Area Under the Plasma Concentration versus Time Curve (AUC) of MNTX and its Metabolites.
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 29 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 bromide 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 4 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 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. 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 and its Metabolites (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 29 Nov 2019.