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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-24

Study Completion Date

2020-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Adult Male

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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VVZ-149 Injections

Group Type EXPERIMENTAL

[14C]-VVZ-149

Intervention Type DRUG

A single IV infusion of radio-labeled VVZ-149

Interventions

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[14C]-VVZ-149

A single IV infusion of radio-labeled VVZ-149

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes