Clinical trials: Methylnaltrexone
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.
Endogenous and Esophageal Sensitivity
The Effect of Naloxone and Methylnaltrexone on Esophageal Sensitivity in Health
The aim of this study was to investigate the effect of naloxone (IV or IM administration) and methylnaltrexone (subcutaneous administration) on esophageal sensitivity, in a group of healthy volunteers in order to evaluate the…
- Trial name
- NCT03014843
- Testing
- Naloxone, Methylnaltrexone Bromide
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
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.
Colonic Inertia
Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?
The investigators want to prove that people WITHOUT advanced cancer who are taking opioid medications (for problems like back pain) can receive methylnaltrexone (MNTX) safely.
- Trial name
- NCT00949377
- Testing
- Methylnaltrexone Bromide (MNTX)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Beth Israel Medical Center
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.
Pharyngeal Dysfunction, Pharyngeal Swallowing
Opioid-Induced Swallowing Dysfunction - The Impact of Bolus Volume
The purpose of the study is to evaluate the impact of different bolus volumes and viscosity on remifentanil-induced swallowing dysfunction in healthy volunteers.Hence, whether swallowing tasks can be done safer during sedation by…
- Trial name
- NCT03283020
- Testing
- RemifentanilMNTX
- Where
- Sweden
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Region Örebro County
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.
Intestinal Obstruction
Effects of Methylnaltrexone in Comparison to Naloxone on Loperamide-induced Delay of the Oro-cecal, Whole-gut and Colon Transit Time.
The purpose of this study is to describe the effects of repeated-dose methylnaltrexone in preventing loperamide-induced delay of whole-gut, oro-cecal and colon transit time and to measure pharmacokinetics of methylnaltrexone and…
- Trial name
- NCT01596764
- Testing
- Loperamide, Colon Transit, Sulfasalazine
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- University Medicine Greifswald
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.
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.
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.
Liver Dysfunction
Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone in Volunteers With Impaired Hepatic Function
This is a multicenter, non-randomized, single-dose, parallel-group study. Each subject will receive a subcutaneous dose of MNTX.
- Trial name
- NCT01367522
- Testing
- SC Methylnaltrexone (MNTX)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- 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.
Gastric Motility Disorder
Effect of Methylnaltrexone on GI Transit in Healthy Volunteers
This is a single-center, randomized, double blind, placebo-controlled study evaluating the effects of placebo, codeine, methylnaltrexone and codeine with methylnaltrexone on gastrointestinal motility and colonic transit of solids…
- Trial name
- NCT01055704
- Testing
- Methylnaltrexone only, Codeine only, Methylnaltrexone + codeine
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Intestinal Obstruction
Effects of 500 mg Immediate Release and Extended Release Methylnaltrexone on Loperamide-induced Delay of the Oro-cecal and Whole-gut Transit Time in Healthy Subjects
The purpose of this study is to describe the effects of methylnaltrexone in preventing loperamide-induced delay of the oro-cecal and whole-gut transit time and measure pharmacokinetics of methylnaltrexone after subcutaneous and…
- Trial name
- LOP-MNTX-2009 (NCT01596777)
- Testing
- Loperamide, Methylnaltrexone 12 mg sc., Methylnaltrexone IR capsule
- Where
- Germany
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University Medicine Greifswald
Healthy Adults
Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide
This double-blind, randomized, two-cohort, placebo-controlled, parallel group study characterized the pharmacokinetics, safety, and tolerability of MNTX following single doses and at steady-state during multiple dosing and…
- Trial name
- NCT01366365
- Testing
- methylnaltrexone
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- 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.
Pharyngeal Dysfunction, Esophageal Dysfunction
Opioids and Esophageal Function
The purpose of this study is to evaluate if opioid-induced effects on the pharynx and esophagus is centrally or peripherally mediated.
- Trial name
- NCT01012960
- Testing
- methylnaltrexone
- Where
- 2 sites in Sweden
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Region Örebro County
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.