Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide

Bausch Health

Status and phase: Completed; Phase 1

Conditions: Healthy Adults

Treatments: Drug: methylnaltrexone; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01366365

MNTX 1303

Details and patient eligibility

About

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 assessed the effects of aging on the pharmacokinetics, safety and tolerability of MNTX.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy Males and females who were between the ages of 18 and 45 years and healthy males and females who were 65 years of age and older.
2. Subjects who were non-smokers
3. Subjects with body weights within range of 70-100 kg (154-220 lbs).

Exclusion criteria

1. Subjects who had previously been exposed to MNTX
2. Subjects with a history of vasovagal episodes or fainting within the past five years
3. Subjects with a history of psychiatric or neurologic disorder
4. Subjects with a history of narrow-angle glaucoma or intraocular hypertension
5. Subjects who had tested positive for hepatitis B surface antigen, IgM hepatitis B core antibody, hepatitis C antibody, or HIV
6. Subjects who have had a diagnosis of alcohol or substance dependence.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Description:

IV methylnaltrexone (MNTX)

Treatment:

Drug: methylnaltrexone

Arm 2

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo