Status:
COMPLETED
Absorption, Metabolism, Excretion, and Mass Balance Study of [14C]-VVZ-149 in Healthy Adult Male Subjects
Lead Sponsor:
Vivozon, Inc.
Conditions:
Healthy Adult Male
Eligibility:
MALE
19-55 years
Phase:
PHASE1
Brief Summary
This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single IV infusion of \[14C\]-VVZ-149 in healthy adult male subjects. Whole blood, plasma, uri...
Eligibility Criteria
Inclusion
- Key
- Healthy, adult, male, 19-55 years of age, inclusive
- Continuous non-smoker
- BMI ≥ 18.0 and ≤ 32.0 kg/m2
- Medically healthy with no clinically significant medical history or findings
- Must agree to adhere to the contraception requirements
- Key
Exclusion
- History or presence of clinically significant medical or psychiatric condition or disease
- History or presence of alcohol or drug abuse within the past 2 years
- History, presence or evidence of cardiovascular, renal or hepatic impairment
- Less or abnormal bowel movements
- Unable to refrain from or anticipates the use of any prohibited drugs
- Recent donation of blood/plasma or significant blood loss
- Radiation exposure within 12 months
- Participation in another clinical study within 30 days
Key Trial Info
Start Date :
February 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04415645
Start Date
February 24 2020
End Date
March 31 2020
Last Update
June 4 2020
Active Locations (1)
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1
Celerion
Lincoln, Nebraska, United States, 68502