Healthy
Conditions
Keywords
healthy subjects
Brief summary
Absorption, distribution, metabolism, and excretion (ADME) study with 14C in healthy young men.
Interventions
DRUGMOA-728
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distribution of drug using radioactive study drug. | — |
Outcome results
None listed