Safety and Gastrointestinal Effects of Intravenous Methylnaltrexone

Safety and Gastrointestinal Effects of Multiple-Dosed Intravenous Methylnaltrexone in Healthy Human Volunteers

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01367587

Enrollment

Registered

2011-06-07

Start date

2002-04-30

Completion date

2002-07-31

Last updated

2019-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

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

Interventions

DRUGIV Methylnaltrexone

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Peak Plasma Concentration of IV MNTX	3 weeks	To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

Secondary

Measure	Time frame	Description
Clearance of IV MNTX	3 weeks	To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.
Half-life of IV MNTX	3 weeks	To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.
Time to Maximum Plasma Concentration of IV MNTX	3 weeks	To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.
Area Under the Plasma Concentration versus Time Curve (AUC) of IV MNTX	3 weeks	To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.
Percentage of IV MNTX Excreted in Urine	3 weeks	To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.
Volume of Distribution of IV MNTX	3 weeks	To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026