Study of the Pharmacokinetics of Intravenous Administered 14C-MNTX

Bausch Health

Status and phase: Completed; Phase 1

Conditions: Healthy Male Volunteers

Treatments: Drug: IV methylnaltrexone (MNTX)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01367483

MNTX 102

Details and patient eligibility

About

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 samples. Exhaled 14CO2 will also be sampled as a measure of the extent of possible metabolic MNTX demethylation.

Enrollment: 6 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Males between 18-45
2. Subject weight between 70 and 90 kg
3. In good physical health, with no evidence at screening of acute or chronic disease likely to affect the investigation

Exclusion criteria

1. History or evidence of cardiovascular, gastrointestinal, hepatic, neurological, pulmonary, renal, or other significant chronic condition.
2. Consumption of barbiturates or other inducers or inhibitors of CYP450 isoforms
3. History of or predisposition to erratic or abnormal bowel function.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Arm1

Experimental group

Description:

MNTX active treatment

Treatment:

Drug: IV methylnaltrexone (MNTX)