Clinical trials: Methylnaltrexone
Healthy Adult Subjects
Effect of Cimetidine on the Single-Dose PK of IV- Administered MNTX
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.
- Trial name
- NCT01366378
- Testing
- methylnaltrexone
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Opioid-Induced Constipation
Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness
This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness…
- Trial name
- NCT00672139
- Testing
- Methylnaltrexone bromide
- Where
- 46 sites in United States, Australia and 8 more
- Volunteers
- 156 people
- Sponsor
- Bausch Health Americas, Inc.
Opioid-induced Constipation
Compassionate Use Study of Methylnaltrexone
This is an open label compassionate use study of subcutaneously administered methylnaltrexone (MNTX) in participants with advance medical illness and opioid-induced constipation.
- Trial name
- NCT01368562
- Testing
- Methylnaltrexone
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Bausch Health Americas, Inc.
Bowel Dysfunction
Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction
This is a double-blind, randomized, parallel group, dose ranging study of subcutaneous methylnaltrexone to be conducted in patients with advanced medical illness and poorly controlled opioid induced constipation.
- Trial name
- NCT01367574
- Testing
- SC MNTX
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Bausch Health Americas, Inc.
Healthy Adult Subjects
Evaluate the Pharmacokinetics (PK) of Methylnaltrexone (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.
- Trial name
- NCT01366326
- Testing
- Methylnaltrexone bromide
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Healthy Adults
Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan
This study is a single-center, randomized, open-label, active and placebo-controlled, parallel-group, conducted in healthy male volunteers who have been shown to be extensive metabolizers of dextromethorphan.
- Trial name
- NCT01367535
- Testing
- SC Methylnaltrexone (MNTX), IV Methylnaltrexone (MNTX), Oral Paroxetine
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Postoperative Ileus
Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus
A double-blind, randomized, parallel-group study designed to evaluate the safety and activity of IV MNTX in the treatment of Post-Operative Ileus (POI) in patients who underwent segmental colectomies via laparotomy.
- Trial name
- NCT01367548
- Testing
- IV Methylnaltrexone (MNTX)
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Bausch Health Americas, Inc.
Healthy Males
Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function
This is a double-blind, randomized, study at a single clinical site investigating the effect of methylnaltrexone and naloxone versus placebo in healthy males who have received a short-acting opioid, remifentanil.
- Trial name
- NCT01367561
- Testing
- Naloxone, IV Methylnaltrexone (MNTX)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Opioid-Induced Constipation
Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects
This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids.
- Trial name
- NCT00858754
- Testing
- methylnaltrexone
- Where
- 8 sites in United States, Canada and 2 more
- Sponsor
- Bausch Health Americas, Inc.
Opioid-Induced Constipation
A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain
MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral MNTX for the treatment of opioid induced constipation in…
- Trial name
- NCT01186770
- Testing
- Methylnaltrexone
- Where
- 2 sites in United States
- Volunteers
- 804 people
- Sponsor
- Bausch Health Americas, Inc.
Opioid-induced Constipation
Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures
The purpose of this study is to examine the safety and activity of MNTX in relieving opioid-induced constipation following orthopedic procedures.
- Trial name
- NCT00640146
- Testing
- Methylnaltrexone bromide
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Bausch Health Americas, Inc.
Normal Healthy Volunteers
Tolerance and Pharmacokinetics Study of MNTX Tablets
This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo.
- Trial name
- NCT01366339
- Testing
- Oral methylnaltrexone
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Post Operative Bowel Dysfunction
Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus
Primary Objective: In subjects who have undergone segmental colectomy, the time between the end of surgery and first bowel movement is significantly shorter with the investigational MOA-728 regimen than with a placebo regimen.
- Trial name
- NCT00387309
- Testing
- Methylnaltrexone (MOA-728)
- Where
- 92 sites in United States, Australia and 8 more
- Volunteers
- 495 people
- Sponsor
- Bausch Health Americas, Inc.
Pancreatic Cancer
An Extension Study of Methylnaltrexone Bromide (MNTX) in Participants With Advanced Pancreatic Cancer
This open-label extension study will evaluate the long-term safety and efficacy of oral MNTX in participants with advanced pancreatic cancer (adenocarcinoma) who were previously enrolled in Study SAL-REL-2042 (NCT04083651).
- Trial name
- NCT04151719
- Testing
- Methylnaltrexone bromide (MNTX)
- Sponsor
- Bausch Health Americas, Inc.
Advance Illness Patients With OIC
Study of Methylnaltrexone (MNTX) for the Relief of Constipation
To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.
- Trial name
- NCT00402038
- Testing
- SC Methylnaltrexone
- Where
- United States
- Volunteers
- 134 people
- Sponsor
- Bausch Health Americas, Inc.
Healthy Subjects
Pharmacokinetics and Bioavailability of Single Subcutaneous Doses of Methylnaltrexone Versus Intravenous Dose
This is an open-label, Phase I study. Study treatments will entail a four-way crossover among three single, ascending, subcutaneous doses and one intravenous dose of MNTX in six healthy normal male volunteers.
- Trial name
- NCT01367496
- Testing
- SC Methylnaltrexone (MNTX), IV Methylnaltrexone (MNTX)
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Renal Impairment
Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Subjects With Impaired Renal Function
This study is evaluating the Pharmacokinetics of MNTX in healthy control subjects and in patients with mild, moderate, or severe renal impairment who do not require hemodialysis.
- Trial name
- NCT01367509
- Testing
- Methylnaltrexone (MNTX)
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Healthy Volunteers
Effect of Methylnaltrexone (MNTX) on Electrocardiogram (ECG) Parameters and Cardiac Repolarization
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…
- Trial name
- NCT01363323
- Testing
- Methylnaltrexone (MNTX), Moxifloxacin
- Where
- United States
- Volunteers
- 546 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Healthy Male Volunteers
Study of the Pharmacokinetics of Intravenous Administered 14C-MNTX
This is an open-label, radiotracer study, to be conducted in healthy, normal, male volunteers. It will entail intravenous administration of a single dose of 14C-MNTX, collection of excretions, and periodic drawing of blood…
- Trial name
- NCT01367483
- Testing
- IV methylnaltrexone (MNTX)
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Healthy Volunteers
Safety and Gastrointestinal Effects of Intravenous Methylnaltrexone
This study evaluates the safety of multiple doses of IV MNTX in normal healthy adults.
- Trial name
- NCT01367587
- Testing
- IV Methylnaltrexone
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.