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

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

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