Human Mass Balance Study of HMS5552 in Healthy Subjects

Hua Medicine

Status and phase: Completed; Phase 1

Conditions: Healthy Subject

Treatments: Drug: HMS5552

Study type: Interventional

Funder types: Industry

Identifiers

NCT03158506

HMM0105

Details and patient eligibility

About

This is an open-label, single center, 1-period study in healthy adult male subjects to assess absorption, metabolism, and excretion of HMS5552 after a single oral administration of 50 mg (90 μCi) of [14C]-HMS5552.

Enrollment: 6 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy, adult, male 19-55 years of age
• Weight at least 50 kg, and BMI within the range of 18-30 kg/m2
• Written informed consent must be obtained before any assessment is performed

Exclusion criteria

• History or presence of clinically significant medical, surgical or psychiatric condition or disease in the opinion of the Investigator or designee which might significantly alter the absorption, distribution, metabolism and excretion of drugs.
• History or presence of alcoholism or drug abuse.
• Smoker.
• Abnormal bowel habits.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

[C14]-labelled HMS5552

Experimental group

Treatment:

Drug: HMS5552