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Opioid Antagonist

Arm 3 for Normal, Healthy Volunteers

Phase 1
Waitlist Available
Research Sponsored by Bausch Health Americas, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights

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 dose.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Peak Plasma Concentration (Cmax) of oral doses of MNTX
Secondary outcome measures
Area Under the Plasma Concentration versus Time Curve (AUC) of oral doses of MNTX
Half-life of oral doses of MNTX
Peak Time of Maximum Concentration (Tmax) of oral doses of MNTX

Side effects data

From 2013 Phase 4 trial • 156 Patients • NCT00672139
26%
Disease progression
23%
Abdominal pain
19%
Diarrhea
18%
Asthenia
18%
Oedema peripheral
16%
Confusional state
14%
Fall
12%
Contusion
12%
Dyspnoea
11%
Urinary tract infection
9%
Nausea
9%
Agitation
7%
Vomiting
7%
Decreased appetite
7%
Dizziness
7%
Rales
7%
Lethargy
7%
Anxiety
7%
Dehydration
5%
Anemia
5%
Dysphagia
5%
Flatulence
5%
Back pain
5%
Cough
5%
Fatigue
5%
Restlessness
5%
Laceration
2%
Myocardial infarction
2%
Sepsis
2%
Femoral neck fracture
2%
Hip fracture
2%
Cerebrovascular accident
2%
Chest pain
2%
Pyrexia
2%
Thrombocytopenia
2%
Cardiac failure congestive
2%
Constipation
2%
General physical health deterioration
2%
Pain
2%
Pneumonia aspiration
2%
Renal failure
2%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Methylnaltrexone Bromide 8 mg
Methylnaltrexone Bromide 12 mg

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 3Experimental Treatment1 Intervention
Oral methylnaltrexone
Group II: Arm 2Experimental Treatment1 Intervention
Oral methylnaltrexone
Group III: Arm 1Experimental Treatment1 Intervention
Oral methylnaltrexone
Group IV: Arm 4Placebo Group1 Intervention
Oral placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylnaltrexone
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Bausch Health Americas, Inc.Lead Sponsor
262 Previous Clinical Trials
81,991 Total Patients Enrolled
Tage Ramakrishna, MDStudy DirectorProgenics Pharmaceuticals, Inc.
18 Previous Clinical Trials
1,293 Total Patients Enrolled
~2 spots leftby Sep 2025
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