Absorption, Metabolism, Excretion, and Mass Balance Study of [14C]-VVZ-149 in Healthy Adult Male Subjects

Vivozon

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Male

Treatments: Drug: [14C]-VVZ-149

Study type: Interventional

Funder types: Industry

Identifiers

NCT04415645

VVZ149-HMB-P1-US101

Details and patient eligibility

About

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, urine, and fecal samples will be analyzed for at least 72 hours following the start of infusion to measure total radioactivity and plasma drug concentrations.

Enrollment: 6 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 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 Criteria:

• 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

VVZ-149 Injections

Experimental group

Treatment:

Drug: [14C]-VVZ-149