MedPath

Methylnaltrexone

Generic Name
Methylnaltrexone
Brand Names
Relistor
Drug Type
Small Molecule
Chemical Formula
C21H26NO4
CAS Number
916055-93-1
Unique Ingredient Identifier
0RK7M7IABE
Background

Methylnaltrexone is a pheriphally-acting μ-opioid antagonist that acts on the gastrointestinal tract to decrease opioid-induced constipation without producing analgesic effects or withdrawal symptoms. It is also a weak CYP2D6 inhibitor. FDA approved in 2008.

Indication

Treatment of opioids induced constipation in palliative patients that are inadequately responding to laxative therapy.

Associated Conditions
Opioid Induced Constipation (OIC)

Effect of Cimetidine on the Single-Dose PK of IV- Administered MNTX

Phase 1
Completed
Conditions
Healthy Adult Subjects
Interventions
First Posted Date
2011-06-06
Last Posted Date
2019-11-27
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
18
Registration Number
NCT01366378
Locations
🇺🇸

Progenics Pharmaceuticals, Inc., Tarrytown, New York, United States

Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide

Phase 1
Completed
Conditions
Healthy Adults
Interventions
First Posted Date
2011-06-06
Last Posted Date
2019-11-27
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
28
Registration Number
NCT01366365
Locations
🇺🇸

Progenics Pharmaceuticals, Inc., Tarrytown, New York, United States

Tolerance and Pharmacokinetics Study of MNTX Tablets

Phase 1
Completed
Conditions
Normal Healthy Volunteers
Interventions
Drug: Oral placebo
First Posted Date
2011-06-06
Last Posted Date
2019-11-27
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
37
Registration Number
NCT01366339
Locations
🇺🇸

Progenics Pharmaceuticals, Inc., Tarrytown, New York, United States

Evaluate the Pharmacokinetics (PK) of Methylnaltrexone (MNTX) in Healthy Adult Subjects

Phase 1
Completed
Conditions
Healthy Adult Subjects
Interventions
First Posted Date
2011-06-06
Last Posted Date
2019-11-29
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
20
Registration Number
NCT01366326
Locations
🇺🇸

Progenics Pharmaceuticals, Inc., Tarrytown, New York, United States

Pharmacokinetics and Bioavailability Comparison of Two Different Formulations of MNTX Tablets

Phase 1
Completed
Conditions
Normal Volunteers
Interventions
First Posted Date
2011-06-06
Last Posted Date
2019-11-27
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
24
Registration Number
NCT01366352
Locations
🇺🇸

Progenics Pharmaceuticals, Inc., Tarrytown, New York, United States

Effect of Methylnaltrexone (MNTX) on Electrocardiogram (ECG) Parameters and Cardiac Repolarization

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2011-06-01
Last Posted Date
2019-11-29
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
546
Registration Number
NCT01363323
Locations
🇺🇸

Progenics Pharmaceuticals, Tarrytown, New York, United States

Effect of Methylnaltrexone (Relistor) on Digestion and Tolerance to Tube Feeding in Patients Treated With Opiates

Phase 3
Withdrawn
Conditions
Tube Feeding
Interventions
Drug: Saline injection
First Posted Date
2011-05-25
Last Posted Date
2015-03-17
Lead Sponsor
Drexel University
Registration Number
NCT01360372
Locations
🇺🇸

Cancer Treatment Center of America, Philadelphia, Pennsylvania, United States

🇺🇸

Hahnemann University Hospital, Philadelphia, Pennsylvania, United States

A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain

Phase 3
Completed
Conditions
Opioid-Induced Constipation
Interventions
First Posted Date
2010-08-23
Last Posted Date
2019-09-06
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
804
Registration Number
NCT01186770
Locations
🇺🇸

PRA International, Raleigh, North Carolina, United States

🇺🇸

PRA, Intl., Raleigh, North Carolina, United States

Methylnaltrexone vs Erythromycin for Facilitating Gastric Emptying Time in Critically Ill Patients

Phase 2
Terminated
Conditions
Gastroparesis
Interventions
First Posted Date
2010-05-05
Last Posted Date
2011-03-31
Lead Sponsor
Shiraz University of Medical Sciences
Target Recruit Count
42
Registration Number
NCT01117376
Locations
🇮🇷

Nemazee Hospital, Shiraz, Fars, Iran, Islamic Republic of

Effect of Methylnaltrexone on GI Transit in Healthy Volunteers

Phase 4
Completed
Conditions
Gastric Motility Disorder
Interventions
First Posted Date
2010-01-26
Last Posted Date
2012-06-25
Lead Sponsor
Mayo Clinic
Target Recruit Count
48
Registration Number
NCT01055704
Locations
🇺🇸

Mayo Clinic Rochester, Rochester, Minnesota, United States

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