Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide

Healthy Adults Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366365
• Other study ID #: MNTX 1303
• Status: Completed
• Phase: Phase 1
• Start date: October 2006
• Est. completion date: November 2006

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Drug:
• methylnaltrexone

• placebo

Locations

Country	Name	City	State
United States	Progenics Pharmaceuticals, Inc.	Tarrytown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clearance of MNTX	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	7 days
Secondary	Half-life of MNTX	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	7 days
Secondary	Volume of distribution of MNTX	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	7 days
Secondary	Area under the plasma concentration (AUC) of MNTX	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	7 days
Secondary	Number of Subjects with Adverse Events	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	7 days