Safety and Gastrointestinal Effects of Intravenous Methylnaltrexone

Phase 2CompletedNCT01367587

Bausch Health Americas, Inc.12 enrolled

Overview

This study evaluates the safety of multiple doses of IV MNTX in normal healthy adults.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

12

Conditions

Healthy Volunteers

Interventions

IV MethylnaltrexoneDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Must be male or non-pregnant female volunteers 2. Must be 18 to 65 yrs of age 3. Must have no significant active disease states Exclusion Criteria: 1. History or current evidence of disease (cardiovascular, respiratory, endocrine, renal, hepatic, hematological, or psychiatric) 2. Illicit drug users 3. Subjects who received an experimental new drug in the past 30 days 4. Subjects with any laboratory findings outside normal limits

Locations (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, United States

Outcomes

Primary Outcomes

Peak Plasma Concentration of IV MNTX

To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

Time frame: 3 weeks

Secondary Outcomes

Time to Maximum Plasma Concentration of IV MNTX

To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

Time frame: 3 weeks

Clearance of IV MNTX

To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

Time frame: 3 weeks

Half-life of IV MNTX

To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

Time frame: 3 weeks

Volume of Distribution of IV MNTX

To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

Time frame: 3 weeks

Area Under the Plasma Concentration versus Time Curve (AUC) of IV MNTX

To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

Time frame: 3 weeks

Percentage of IV MNTX Excreted in Urine

To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

Time frame: 3 weeks

Data from ClinicalTrials.gov

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NCT01367587 - Safety and Gastrointestinal Effects of Intravenous Methylnaltrexone | Crick | Crick