Clinical trials: Methylnaltrexone
- Condition Methylnaltrexone
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
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 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
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 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.
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.
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.
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.
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.
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 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.
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.
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.