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

Healthy Adult Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366378
• Other study ID #: MNTX 1304
• Status: Completed
• Phase: Phase 1
• Start date: January 2007
• Est. completion date: February 2007

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Adult Subjects

Intervention

Drug:
• methylnaltrexone

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	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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