NCT00427258

Brief Summary

Absorption, distribution, metabolism, and excretion (ADME) study with 14C in healthy young men.

Trial Health

10
At Risk

Trial Health Score

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

Status
withdrawn

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

First Submitted

Initial submission to the registry

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
2.9 years until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
Last Updated

November 29, 2019

Status Verified

November 1, 2019

First QC Date

January 25, 2007

Last Update Submit

November 26, 2019

Conditions

Healthy

Keywords

healthy subjects

Outcome Measures

Primary Outcomes (1)

  • Distribution of drug using radioactive study drug.

Interventions

MOA-728DRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men aged 18 to 50 years inclusive at screening.
  • Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥50 kg. BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's height, in meters, at screening: BMI = weight (kg)/\[height (m)\]2
  • Healthy as determined by the investigator on the basis of screening evaluations.
  • Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Jeff Cohn

    Bausch Health Americas, Inc.

    STUDY DIRECTOR
0

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

January 25, 2007

First Posted

January 29, 2007

Study Start

January 1, 2010

Last Updated

November 29, 2019

Record last verified: 2019-11