The Mass Balance and Biotransformation Study of [14C] VC005 in Chinese Healthy Adult Male Volunteers

Jiangsu Vcare PharmaTech

Status and phase

Completed

Phase 1

Conditions

Atopic Dermatitis

Treatments

Drug: [14C]VC005

Study type

Interventional

Funder types

Industry

Identifiers

VC005-105

Details and patient eligibility

About

This study was designed to evaluate the mass balance and biotransformation after single-dose of [14C]VC005 orally in Chinese healthy male volunteers.

Enrollment

6 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

A healthy male adult.
Age is between 18 and 45, inclusive.
Weight ≥ 50 kg and Body mass index is between 19 and 26, inclusive.
Voluntarily to provide informed consent form.
Willing and able to communicate with investigators and complete the trial according to clinical trial protocol.

Exclusion criteria

Any abnormal and clinical significant findings to physical examination, vital signs, laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, stool routine+occult blood, thyroid function), 12 lead electrocardiogram, chest X-ray (upright position), abdominal ultrasound (liver, gallbladder, pancreas, spleen and kidney), anal directorial rectum examination, and so on.
Tested positive for any one of the following: HBsAg/HBeAg, Anti-HCV IgG, HIV-Ag/Ab or treponema pallidum antibody (Syphilis) .
Volunteers who have to work in radioactive conditions in long time, participated in radio-labeled drug clinical trial or had significant radioactive exposure within one year before the trial, more than 2 times of chest/abdominal CT, or more than 3 times of different types of X-ray exam.
Volunteers are not suitable for this clinical trial, in the opinions of investigators.