Effect of Cimetidine on the Single-Dose PK of IV- Administered MNTX

A Phase 1, Open-Label, Study of the Effect of Cimetidine, a Known Inhibitor of Active Renal Secretion, on the Single-Dose Pharmacokinetics of Intravenously-Administered Methylnaltrexone in Healthy Adults

This open-label study assesses the single-dose pharmacokinetics of intravenously-administered MNTX in healthy adult male and female subjects in the absence of, and in the presence of, orally-administered cimetidine.

Study Overview

• Status: Completed
• Conditions: Healthy Adult Subjects
• Intervention / Treatment: Drug: methylnaltrexone

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Tarrytown, New York, United States, 10591
      • Progenics Pharmaceuticals, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy males and females between the ages of 18 and 45
2. Subjects who are non-smokers
3. Subjects with body weights with range of 154-220 lbs.

Exclusion Criteria:

1. Females who are pregnant or lactating
2. Subjects with a history of any clinically significant disease or condition affecting a major organ system
3. Subjects with ECG abnormalities
4. Subjects who have tested positive for hepatitis B, hepatitis C or HIV
5. Subjects who have had a diagnosis of alcohol or substance dependence with the past 12 months
6. Subjects with positive urine results for drugs of abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1; methylnaltrexone (MNTX)	Drug: methylnaltrexone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak plasma concentration (Cmax) of MNTX prior to and following multi-dose cimetidine regimen	To assess the potential effects of cimetidine on the pharmacokinetics of MNTX	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration (AUC) of MNTX prior to and following a multi-dose cimetidine regimen	To assess the potential effects of cimetidine on the pharmacokinetics of MNTX	7 days
Half-life of MNTX prior to and following a multi-dose cimetidine regimen	To assess the potential effects of cimetidine on the pharmacokinetics of MNTX	7 days
Clearance (both total and renal)of MNTX prior to and following a multi-dose cimetidine regimen	To assess the potential effects of cimetidine on the pharmacokinetics of MNTX	7 days
Volume of distribution of MNTX prior to and following a multi-dose cimetidine regimen	To assess the potential effects of cimetidine on the pharmacokinetics of MNTX	7 days
Number of subject with adverse events as measured before, during, and after administration of cimetidine	To assess the potential effects of cimetidine on safety, and tolerability of MNTX	7 days

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (ACTUAL): February 1, 2007
• Study Completion (ACTUAL): February 1, 2007

Study Registration Dates

• First Submitted: May 27, 2011
• First Submitted That Met QC Criteria: June 2, 2011
• First Posted (ESTIMATE): June 6, 2011

Study Record Updates

• Last Update Posted (ACTUAL): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 26, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Methylnaltrexone
• Other Study ID Numbers: MNTX 1304