Skip to main content
OpenTrials
Completed

NCT Number: NCT03158506

Human Mass Balance Study of HMS5552 in Healthy 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Subject

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HMS5552

Drug

[14C]-labelled HMS5552

Primary outcomes

  1. Total radioactivity in blood, plasma urine and feces

    Time frame: Up to 168 hours

    Peak plasma concentration (Cmax)

  2. Total radioactivity in blood, plasma urine and feces

    Time frame: Up to 168 hours

    Area under the plasma concentration versus time curve (AUC)

  3. Total radioactivity in blood, plasma urine and feces

    Time frame: Up to 168 hours

    Time to reach Cmax (Tmax)

  4. Total radioactivity in blood, plasma urine and feces

    Time frame: Up to 168 hours

    Total radioactivity in urine and faeces at each time interval and cumulative radioactivity (mass balance)

Secondary outcomes

  1. Concentrations of HMS5552 and its metabolites in plasma, urine and feces

    Time frame: Up to 168 hours

    Peak plasma concentration (Cmax)

  2. Number of participants with adverse events as a measure of safety and tolerability

    Time frame: 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

    Time frame: 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

    Time frame: Up to 168 hours

    Time to reach Cmax (Tmax)

Sponsors and collaborators

Lead sponsor

Hua Medicine Limited

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 18, 2017
Registry last updated
Dec 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.