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

Phase 1

Completed

• Conditions: Healthy Adult Subjects
• Interventions: Drug: methylnaltrexone

• Registration Number: NCT01366378
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-06-02
• Study First Posted: 2011-06-06
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	methylnaltrexone	methylnaltrexone (MNTX)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Progenics Pharmaceuticals, Inc.; 🇺🇸 Tarrytown, New York, United States