Human Mass Balance Study of HMS5552 in Healthy Subjects
- Registration Number
- NCT03158506
- Lead Sponsor
- Hua Medicine Limited
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [C14]-labelled HMS5552 HMS5552 -
- Primary Outcome Measures
Name Time Method Total radioactivity in blood, plasma urine and feces Up to 168 hours Total radioactivity in urine and faeces at each time interval and cumulative radioactivity (mass balance)
- Secondary Outcome Measures
Name Time Method Concentrations of HMS5552 and its metabolites in plasma, urine and feces Up to 168 hours Time to reach Cmax (Tmax)
Number of participants with adverse events as a measure of safety and tolerability Up to 168 hours Adverse events; Laboratory parameters; Vital signs, clinical signs and symptoms and physical examination, including changes from baseline; ECG evaluation
Trial Locations
- Locations (1)
Celerion
🇺🇸Lincoln, Nebraska, United States