Human Mass Balance Study of HMS5552 in Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subject
• Intervention / Treatment: Drug: HMS5552

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [C14]-labelled HMS5552	Drug: HMS5552; [14C]-labelled HMS5552

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total radioactivity in blood, plasma urine and feces	Peak plasma concentration (Cmax)	Up to 168 hours
Total radioactivity in blood, plasma urine and feces	Area under the plasma concentration versus time curve (AUC)	Up to 168 hours
Total radioactivity in blood, plasma urine and feces	Time to reach Cmax (Tmax)	Up to 168 hours
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentrations of HMS5552 and its metabolites in plasma, urine and feces	Peak plasma concentration (Cmax)	Up to 168 hours
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
Concentrations of HMS5552 and its metabolites in plasma, urine and feces	Area under the plasma concentration versus time curve (AUC)	Up to 168 hours
Concentrations of HMS5552 and its metabolites in plasma, urine and feces	Time to reach Cmax (Tmax)	Up to 168 hours

Collaborators and Investigators

• Sponsor: Hua Medicine Limited

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2017
• Primary Completion (Actual): April 6, 2017
• Study Completion (Actual): April 6, 2017

Study Registration Dates

• First Submitted: May 10, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (Actual): May 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 31, 2018
• Last Update Submitted That Met QC Criteria: December 27, 2018
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: HMM0105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No