Human Mass Balance Study of HMS5552 in Healthy Subjects

Healthy Subject Clinical Trial

Official title:

An Open-Label, Single Center Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of 50 mg (90 uCi) [14C]-HMS5552 in Healthy Adult Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03158506
• Other study ID #: HMM0105
• Status: Completed
• Phase: Phase 1
• Start date: March 29, 2017
• Est. completion date: April 6, 2017

Study information

• Verified date: April 2017
• Source: Hua Medicine Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 6, 2017
• Est. primary completion date: April 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subject

Intervention

Drug:
• HMS5552
[14C]-labelled HMS5552

Locations

Country	Name	City	State
United States	Celerion	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Hua Medicine Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total radioactivity in blood, plasma urine and feces	Peak plasma concentration (Cmax)	Up to 168 hours
Primary	Total radioactivity in blood, plasma urine and feces	Area under the plasma concentration versus time curve (AUC)	Up to 168 hours
Primary	Total radioactivity in blood, plasma urine and feces	Time to reach Cmax (Tmax)	Up to 168 hours
Primary	Total radioactivity in blood, plasma urine and feces	Total radioactivity in urine and faeces at each time interval and cumulative radioactivity (mass balance)	Up to 168 hours
Secondary	Concentrations of HMS5552 and its metabolites in plasma, urine and feces	Peak plasma concentration (Cmax)	Up to 168 hours
Secondary	Number of participants with adverse events as a measure of safety and tolerability	Adverse events; Laboratory parameters; Vital signs, clinical signs and symptoms and physical examination, including changes from baseline; ECG evaluation	Up to 168 hours
Secondary	Concentrations of HMS5552 and its metabolites in plasma, urine and feces	Area under the plasma concentration versus time curve (AUC)	Up to 168 hours
Secondary	Concentrations of HMS5552 and its metabolites in plasma, urine and feces	Time to reach Cmax (Tmax)	Up to 168 hours