NCT01367587

Brief Summary

This study evaluates the safety of multiple doses of IV MNTX in normal healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_2 healthy-volunteers

Timeline
Completed

Started Apr 2002

Shorter than P25 for phase_2 healthy-volunteers

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
8.9 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

June 2, 2011

Last Update Submit

November 26, 2019

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Peak Plasma Concentration of IV MNTX

    To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

    3 weeks

Secondary Outcomes (6)

  • Time to Maximum Plasma Concentration of IV MNTX

    3 weeks

  • Clearance of IV MNTX

    3 weeks

  • Half-life of IV MNTX

    3 weeks

  • Volume of Distribution of IV MNTX

    3 weeks

  • Area Under the Plasma Concentration versus Time Curve (AUC) of IV MNTX

    3 weeks

  • +1 more secondary outcomes

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: IV Methylnaltrexone

Interventions

IV MethylnaltrexoneDRUG
Arm 1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be male or non-pregnant female volunteers
  • Must be 18 to 65 yrs of age
  • Must have no significant active disease states

You may not qualify if:

  • History or current evidence of disease (cardiovascular, respiratory, endocrine, renal, hepatic, hematological, or psychiatric)
  • Illicit drug users
  • Subjects who received an experimental new drug in the past 30 days
  • Subjects with any laboratory findings outside normal limits

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 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 2, 2011

First Posted

June 7, 2011

Study Start

April 1, 2002

Primary Completion

July 1, 2002

Study Completion

July 1, 2002

Last Updated

November 27, 2019

Record last verified: 2019-11

Locations

US(1)