NCT01366378

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 6, 2011

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

1 month

First QC Date

May 27, 2011

Last Update Submit

November 26, 2019

Conditions

Healthy Adult Subjects

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Area under the plasma concentration (AUC) of MNTX prior to and following a multi-dose cimetidine regimen

    7 days

  • Half-life of MNTX prior to and following a multi-dose cimetidine regimen

    7 days

  • Clearance (both total and renal)of MNTX prior to and following a multi-dose cimetidine regimen

    7 days

  • Volume of distribution of MNTX prior to and following a multi-dose cimetidine regimen

    7 days

  • Number of subject with adverse events as measured before, during, and after administration of cimetidine

    7 days

Study Arms (1)

Arm 1

EXPERIMENTAL

methylnaltrexone (MNTX)

Drug: methylnaltrexone

Interventions

methylnaltrexoneDRUG
Arm 1

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Location

MeSH Terms

Interventions

methylnaltrexone

Study Officials

  • Tage Ramakrishna, MD

    Progenics Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 27, 2011

First Posted

June 6, 2011

Study Start

January 1, 2007

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

November 27, 2019

Record last verified: 2019-11

Locations

US(1)