NCT01367535

Brief Summary

This study is a single-center, randomized, open-label, active and placebo-controlled, parallel-group, conducted in healthy male volunteers who have been shown to be extensive metabolizers of dextromethorphan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2006

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2011

Completed
11 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

5 months

First QC Date

May 27, 2011

Last Update Submit

November 26, 2019

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (1)

  • Plasma Concentration of MNTX

    The objective of this study is to assess the effect of SC or IV doses of MNTX on CYP450 2D6 activity.

    4 months

Secondary Outcomes (1)

  • Plasma Concentration of Paroxetine

    4 months

Study Arms (4)

Arm 1

EXPERIMENTAL
Drug: SC Methylnaltrexone (MNTX)

Arm 2

EXPERIMENTAL
Drug: IV Methylnaltrexone (MNTX)

Arm 3

ACTIVE COMPARATOR
Drug: Oral Paroxetine

Arm 4

PLACEBO COMPARATOR
Drug: SC Placebo

Interventions

SC Methylnaltrexone (MNTX)DRUG
Arm 1
IV Methylnaltrexone (MNTX)DRUG
Arm 2
Oral ParoxetineDRUG
Arm 3
SC PlaceboDRUG
Arm 4

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males between the ages of 18 and 55
  • Non-Smokers
  • Body weight range form 154-220 lbs
  • No history of clinically significant metabolic disorders.

You may not qualify if:

  • Any history of low CYP450 2D6 activity
  • History of alcohol abuse or recreational drugs
  • History of any clinically significant disease or condition affecting a major organ system
  • Donation or loss of blood, 60 days proceeding to screening visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Progenics Pharmaceuticals

Tarrytown, New York, 10591, United States

Location

MeSH Terms

Interventions

methylnaltrexoneParoxetine

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Tage Ramakrishna, MD

    Progenics Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 27, 2011

First Posted

June 7, 2011

Study Start

March 1, 2006

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

November 27, 2019

Record last verified: 2019-11

Locations

US(1)