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Human Mass Balance Study of HMS5552 in Healthy Subjects

NCT ID: NCT03158506

Last Updated: 2018-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-29

Study Completion Date

2017-04-06

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Subject

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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[C14]-labelled HMS5552

Group Type EXPERIMENTAL

HMS5552

Intervention Type DRUG

\[14C\]-labelled HMS5552

Interventions

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HMS5552

\[14C\]-labelled HMS5552

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hua Medicine Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Tomek, MD

Role: PRINCIPAL_INVESTIGATOR

Celerion

Locations

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Celerion

Lincoln, Nebraska, United States

Site Status

Countries

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China United States

Other Identifiers

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HMM0105

Identifier Type: -

Identifier Source: org_study_id