Human Mass Balance Study of HMS5552 in Healthy Subjects

• Sponsor: Hua Medicine Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03158506
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Actual Duration (Days): 8
• Patients Per Site Per Month: 22.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subject	Drug: HMS5552	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 29, 2017
• Actual Primary Completion Date: Apr 6, 2017
• Actual Study Completion Date: Apr 6, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Total radioactivity in blood, plasma urine and feces [Up to 168 hours]

   Peak plasma concentration (Cmax)

2. Total radioactivity in blood, plasma urine and feces [Up to 168 hours]

   Area under the plasma concentration versus time curve (AUC)

3. Total radioactivity in blood, plasma urine and feces [Up to 168 hours]

   Time to reach Cmax (Tmax)

4. 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

1. Concentrations of HMS5552 and its metabolites in plasma, urine and feces [Up to 168 hours]

   Peak plasma concentration (Cmax)

2. 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

3. Concentrations of HMS5552 and its metabolites in plasma, urine and feces [Up to 168 hours]

   Area under the plasma concentration versus time curve (AUC)

4. Concentrations of HMS5552 and its metabolites in plasma, urine and feces [Up to 168 hours]

   Time to reach Cmax (Tmax)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Celerion	Lincoln	Nebraska	United States	68502

Sponsors and Collaborators

• Hua Medicine Limited

Investigators

• Principal Investigator: Charles Tomek, MD, Celerion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hua Medicine Limited
• ClinicalTrials.gov Identifier: NCT03158506
• Other Study ID Numbers: HMM0105
• First Posted: May 18, 2017
• Last Update Posted: Dec 31, 2018
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Dec 31, 2018