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NCT00427258 Clinical Trial

Study Evaluating MOA-728 Administered in Healthy Men

Healthy Clinical Trial

Official title:
An Open-Label, Single-Dose Study of the Mass Balance and Metabolic Disposition of Orally Administered [14C]MOA-728 in Healthy Men

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00427258
Other study ID # 3200A3-1106
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date January 2010

Study information
Verified date November 2019
Source Bausch Health Americas, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MOA-728

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bausch Health Americas, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Distribution of drug using radioactive study drug.
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