Normal Healthy VolunteersPhase 1NCT01366339
Tolerance and Pharmacokinetics Study of MNTX Tablets
A Phase 1 study testing Oral methylnaltrexone in people with Normal Healthy Volunteers, run by Bausch Health Americas, Inc. at 1 site in United States.
Trial summary
This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of each active treatment group is further randomized to a second, replicate dose of MNTX, and the placebo group receives an additional placebo… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Healthy Volunteers
- What is being tested?
- Oral methylnaltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Dec 2003
- 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
- Weight between 55 and 85 kg
- In good health with no evidence of a clinically significant chronic medical condition
- Non-Smokers.
Who cannot join
- History of asthma, allergic skin rash, significant allergy or other immunologic disorder
- Known or suspected hypersensitivity to opioids or opioid antagonists
- History or suspicion of alcohol or drug 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 Replicate Design, Double-Blind, Randomized, Placebo-Controlled Tolerance and Pharmacokinetics Study of N-Methylnaltrexone Tablets in Normal, Healthy Volunteers
This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of each active treatment group is further randomized to a second, replicate dose of MNTX, and the placebo group receives an additional placebo dose.
- Conditions
- Normal Healthy Volunteers
- Being tested
- Oral methylnaltrexone, Oral placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral methylnaltrexoneDrug
Oral placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Oral methylnaltrexone Receives: Drug: Oral methylnaltrexone |
| Arm 2 | Experimental | Oral methylnaltrexone Receives: Drug: Oral methylnaltrexone |
| Arm 3 | Experimental | Oral methylnaltrexone Receives: Drug: Oral methylnaltrexone |
| Arm 4 | Placebo comparator | Oral placebo Receives: Drug: Oral placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax) of oral doses of MNTX
To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers
Measured: 7 days
Secondary outcomes (3)
Peak Time of Maximum Concentration (Tmax) of oral doses of MNTX
To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers
Measured: 7 days
Area Under the Plasma Concentration versus Time Curve (AUC) of oral doses of MNTX
To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers
Measured: 7 days
Half-life of oral doses of MNTX
To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers
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 startOct 2003
- Primary completionDec 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 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
- NCT01366339
- Sponsor's protocol ID
- MNTX 1201
- 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 Replicate Design, Double-Blind, Randomized, Placebo-Controlled Tolerance and Pharmacokinetics Study of N-Methylnaltrexone Tablets in Normal, Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01366339
- Acronym / sponsor ID
- MNTX 1201
- Conditions
- Normal Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (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 is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of each active treatment group is further randomized to a second, replicate dose of MNTX, and the placebo group receives an additional placebo dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Oral methylnaltrexoneOral methylnaltrexone |
| Arm 2 | Experimental | Drug: Oral methylnaltrexoneOral methylnaltrexone |
| Arm 3 | Experimental | Drug: Oral methylnaltrexoneOral methylnaltrexone |
| Arm 4 | Placebo comparator | Drug: Oral placeboOral placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Weight between 55 and 85 kg
- In good health with no evidence of a clinically significant chronic medical condition
- Non-Smokers.
Key exclusion criteria (3 listed)
- History of asthma, allergic skin rash, significant allergy or other immunologic disorder
- Known or suspected hypersensitivity to opioids or opioid antagonists
- History or suspicion of alcohol or drug abuse.
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 |
|---|---|---|
| Oral methylnaltrexone | Drug | Arm 1, Arm 2, Arm 3 |
| Oral placebo | Drug | Arm 4 |
Primary outcome
Peak Plasma Concentration (Cmax) of oral doses of MNTX
Time frame: 7 days
To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers
3 secondary outcomes
Peak Time of Maximum Concentration (Tmax) of oral doses of MNTX
Time frame: 7 days
Area Under the Plasma Concentration versus Time Curve (AUC) of oral doses of MNTX
Time frame: 7 days
Half-life of oral doses of MNTX
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.
Related trials for Normal Healthy Volunteers
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
A Longitudinal Investigation of the Endocrine and Neurobiologic Events Accompanying Puberty
fMRI
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
RecruitingObservational study
Characterization of Diseases With Salivary Gland Involvement
Healthy Volunteer, Sjogren's Syndrome
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 Oral methylnaltrexone in people with Normal 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 3 inclusion and 3 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?
Peak Plasma Concentration (Cmax) of oral doses of MNTX (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.