Healthy SubjectPhase 1NCT03158506
Human Mass Balance Study of HMS5552 in Healthy Subjects
A Phase 1 study testing HMS5552 in people with Healthy Subject, run by Hua Medicine Limited at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject
- What is being tested?
- HMS5552
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2017to 6 Apr 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy Subject
- Being tested
- HMS5552
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMS5552Drug
[14C]-labelled HMS5552
| Study group | Role | What they receive |
|---|---|---|
| [C14]-labelled HMS5552 | Experimental | Not described Receives: Drug: HMS5552 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radioactivity in blood, plasma urine and feces
Peak plasma concentration (Cmax)
Measured: Up to 168 hours
Total radioactivity in blood, plasma urine and feces
Area under the plasma concentration versus time curve (AUC)
Measured: Up to 168 hours
Total radioactivity in blood, plasma urine and feces
Time to reach Cmax (Tmax)
Measured: 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)
Measured: Up to 168 hours
Secondary outcomes (4)
Concentrations of HMS5552 and its metabolites in plasma, urine and feces
Peak plasma concentration (Cmax)
Measured: 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
Measured: Up to 168 hours
Concentrations of HMS5552 and its metabolites in plasma, urine and feces
Area under the plasma concentration versus time curve (AUC)
Measured: Up to 168 hours
Concentrations of HMS5552 and its metabolites in plasma, urine and feces
Time to reach Cmax (Tmax)
Measured: Up to 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start29 Mar 2017
- Primary completion6 Apr 2017
- Study completion6 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hua Medicine Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Tomek, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158506
- Sponsor's protocol ID
- HMM0105
- Status last verified
- Apr 2017
- First submitted
- 10 May 2017
- Last updated
- 31 Dec 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03158506
- Acronym / sponsor ID
- HMM0105
- Conditions
- Healthy Subject
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Hua Medicine LimitedIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 6 Apr 2017 (actual)
- Study completion
- 6 Apr 2017 (actual)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [C14]-labelled HMS5552 | Experimental | Drug: HMS5552 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMS5552[14C]-labelled HMS5552 | Drug | [C14]-labelled HMS5552 |
Primary outcome
Total radioactivity in blood, plasma urine and feces
Time frame: Up to 168 hours
Peak plasma concentration (Cmax)
Total radioactivity in blood, plasma urine and feces
Time frame: Up to 168 hours
Area under the plasma concentration versus time curve (AUC)
Total radioactivity in blood, plasma urine and feces
Time frame: Up to 168 hours
Time to reach Cmax (Tmax)
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)
4 secondary outcomes
Concentrations of HMS5552 and its metabolites in plasma, urine and feces
Time frame: Up to 168 hours
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 168 hours
Concentrations of HMS5552 and its metabolites in plasma, urine and feces
Time frame: Up to 168 hours
Concentrations of HMS5552 and its metabolites in plasma, urine and feces
Time frame: Up to 168 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Tomek, MD principal investigator
Celerion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HMS5552 in people with Healthy Subject, run by Hua Medicine Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total radioactivity in blood, plasma urine and feces (time frame: Up to 168 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2018.