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Completed

NCT Number: NCT01366365

Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide

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.

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Key information

Conditions

Healthy Adults

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Subjects who were non-smokers
  • Subjects with body weights within range of 70-100 kg (154-220 lbs).

Exclusion criteria

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

Treatment and study plan

methylnaltrexone

Drug

Placebo

Drug

Primary outcomes

  1. Clearance of MNTX

    Time frame: 7 days

    Evaluate the PK of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses

Secondary outcomes

  1. Half-life of MNTX

    Time frame: 7 days

    Evaluate the PK of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses

  2. Volume of distribution of MNTX

    Time frame: 7 days

    Evaluate the PK of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses

  3. Area under the plasma concentration (AUC) of MNTX

    Time frame: 7 days

    Evaluate the PK of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses

  4. Number of Subjects with Adverse Events

    Time frame: 7 days

    Safety and tolerability of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study title

A Phase 1 Randomized, Double-Blind, Placebo Controlled Parallel Group Study of the Pharmacokinetics, Safety and Tolerability of Methylnaltrexone Bromide Administered as Single and Multiple Intravenous Doses to Healthy Adults and Elderly Male and Female Subjects

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jun 6, 2011
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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