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MNTX · 2 trials · 2 indications
To access the efficacy of various fixed unit doses of MNTX SC in patients with advanced medical illnesses and poorly controlled opioid-induced constipation.
To determine and compare the plasma pharmacokinetics and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Arm 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| SC MNTX | DRUG | Dose 1 |
| MNTX tablet (Formulation 1) | DRUG | - |
| MNTX tablet (Formulation 2) | DRUG | - |
Inclusion Criteria: 1. Must have advanced medical illness (cancer, HIV, etc) and be receiving palliative care 2. Must be on opioid medication for at least 2 weeks with no expectation of significant change in regimen 3. Must have constipation 4. Must be 18 yrs or older Exclusion Criteria: 1. Concu...
MNTX is being studied for opioid-induced bowel dysfunction, a gastrointestinal condition. It is an investigational small molecule in clinical development. The drug has been evaluated in patients with bowel dysfunction related to opioid use, and it is not approved for any use.
MNTX is being developed by Bausch Health Companies Inc., a company traded on the New York Stock Exchange under the ticker BHC. The company is conducting clinical research on this investigational drug for gastrointestinal conditions.
MNTX is in Phase 2 clinical development. It has completed a Phase 2 trial in patients with opioid-induced bowel dysfunction. The drug is investigational and has not been approved by regulatory authorities.
MNTX has been studied in two completed clinical trials. NCT01366352 was a Phase 1 pharmacokinetic and bioavailability study in healthy volunteers. NCT01367574 was a Phase 2 trial in patients with opioid-induced bowel dysfunction. Both trials were conducted in the United States.
MNTX is a name used for methylnaltrexone in clinical trials. The Phase 2 trial NCT01367574 is titled "Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction," indicating that MNTX refers to this compound.