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
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 6, 2017
CompletedFirst Submitted
Initial submission to the registry
May 10, 2017
CompletedFirst Posted
Study publicly available on registry
May 18, 2017
CompletedDecember 31, 2018
April 1, 2017
8 days
May 10, 2017
December 27, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (4)
Concentrations of HMS5552 and its metabolites in plasma, urine and feces
Up to 168 hours
Number of participants with adverse events as a measure of safety and tolerability
Up to 168 hours
Concentrations of HMS5552 and its metabolites in plasma, urine and feces
Up to 168 hours
Concentrations of HMS5552 and its metabolites in plasma, urine and feces
Up to 168 hours
Study Arms (1)
[C14]-labelled HMS5552
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Celerion
Lincoln, Nebraska, 68502, United States
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Tomek, MD
Celerion
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2017
First Posted
May 18, 2017
Study Start
March 29, 2017
Primary Completion
April 6, 2017
Study Completion
April 6, 2017
Last Updated
December 31, 2018
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share