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Healthy VolunteerPhase 1NCT05468346

Study on the Body Mass Balance and Biotransformation of [14C]-HEC585

A Phase 1 study testing [14C]-HEC585 in people with Healthy Volunteer, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-centre, open-label, non-randomised, single-dose study in healthy male subjects designed to assess the mass balance and biotransformation of [14C]-HEC-585. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
What is being tested?
[14C]-HEC585
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
26 Jul 2022to 29 Aug 2022
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 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy males, age: 18 to 45 years old (including the critical value);
  • The body weight is not less than 50 kg, and the body mass index (BMI) is in the range of 19.0~26.0 kg/m2 (including the critical value);
  • Voluntarily participate in this trial, sign the informed consent form before the trial begins, and fully understand the trial content, process and possible risks;
  • Subjects were able to communicate well with investigators and were able to complete the trial as specified in the protocol.

Who cannot join

  • Comprehensive physical examination, vital signs, laboratory tests [blood routine, blood biochemistry, urine routine, coagulation function, fecal occult blood, thyroid function test (FT3, FT4, TSH)], 12-lead electrocardiogram, X-chest X-ray (frontal) or chest CT, abdominal B-ultrasound (liver, gallbladder, pancreas, spleen and kidneys), new crown screening (nucleic acid + C-reactive protein) and other abnormal and clinically significant examinations;
  • Those who are positive for any one of hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody and syphilis antibody;
  • Those who have taken any drugs that inhibit or induce liver metabolism of drugs within 28 days before screening (see Appendix 1 for details);
  • Use of any prescription or over-the-counter medicines, any vitamin products, health medicines or Chinese herbal medicines within 14 days prior to screening;
  • Those who participated in any clinical trial and received intervention of experimental drugs or medical devices within 3 months before the screening period;
  • Those who have been vaccinated within 1 month before screening or have a vaccination plan during the trial;
Show all 23Show fewer
  • Have any clinical history of serious diseases or diseases or conditions that the researchers believe may affect the results of the test, including but not limited to the circulatory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic diseases history;
  • Those who have had heart failure, angina pectoris, myocardial infarction, clinically significant arrhythmia and other heart diseases in the past;
  • Those who have undergone major surgery within 6 months before the screening period or the surgical incision is not completely healed. Major surgery includes but is not limited to any surgery with significant bleeding risk, prolonged general anesthesia, or incision biopsy or obvious traumatic injury ;
  • Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before screening;
  • Have clinically significant bleeding symptoms or a clear bleeding tendency within 3 months before screening, such as gastrointestinal bleeding, hemorrhagic gastric ulcer;
  • Hemorrhoids or perianal diseases with regular/hematochezia, abnormal gastrointestinal function such as irritable bowel syndrome and inflammatory bowel disease, which may affect drug absorption as judged by the researchers;
  • People with allergies, including drug allergies or food allergies, or those who have special requirements for diet and cannot follow a unified diet;
  • Habitual constipation or diarrhea;
  • Binge drinking or frequent drinking within 6 months prior to the screening period, i.e. drinking more than 14 units of alcohol per week (1 unit = 285 mL of beer or 25 mL of 40% alcohol or 100 mL of wine) or alcohol during the screening period Breath test results ≥ 20 mg/dL;
  • Those who smoked more than 5 cigarettes or habitually used nicotine-containing products in the first 3 months of the screening period, and were unable to quit during the trial;
  • Drug abuse or use of soft drugs (such as marijuana) 3 months before the screening period or hard drugs (such as: cocaine, amphetamines, phencyclidine, etc.) 1 year before the screening period, or urine drugs during the screening period ( Drugs) screening test positive;
  • Habitual drinking of grapefruit juice or excessive tea, coffee and/or caffeinated beverages and unable to quit during the trial period;
  • Those with a history of fainting of needles or blood, difficult to collect blood or unable to tolerate venipuncture for blood collection;
  • Workers who need to be exposed to radioactive conditions for a long time, or have significant radioactive exposure (≥2 chest/abdominal CT, or ≥3 other types of X-ray examinations) within 1 year before the test, or have participated in radiopharmaceutical labeling experimenter;
  • Those who have fertility plans during the trial and within 12 months after the administration of the trial drug, or who do not agree that the subjects and their spouses should take strict contraceptive measures during the trial and within 12 months after the administration of the trial drug (see details for details). Appendix 2);
  • Those who have lost blood or donated blood up to 400 mL within 3 months before the screening period, or who have received blood transfusion, or who plan to donate blood within 3 months after the end of this trial;
  • According to the judgment of the investigator, the subject has other factors that make it inappropriate to participate in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

Other trials in China

About this study

Official title: Clinical Trial of Absorption, Metabolism and Excretion of [14C]-HEC585 in Chinese Adult Male Healthy Subjects

This is a single-centre, open-label, non-randomised, single-dose study in healthy male subjects designed to assess the mass balance and biotransformation of [14C]-HEC-585.

Being tested
[14C]-HEC585

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C]-HEC585Drug

    Single Dose = Solution containing 200 mg/100 µCi [14C]-HEC585

Study groups in NCT05468346
Study groupRoleWhat they receive
[14C]-HEC585Experimental[14C]-HEC585,solid powder，200 mg/100 µCi,single dose，oral
Receives: Drug: [14C]-HEC585

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mass balance

    To determine the mass balance recovery of orally administered [14C]-HEC585

    Measured: plasma up to 312 hours post dose, urine and fecal samples up to 504 hours post dose

Secondary outcomes (3)

  1. Peak Plasma Concentration (Cmax) of HEC-585 and its major metabolites

    Analyze the Peak Plasma Concentration (Cmax) of HEC-585 and its major metabolites (if applicable) to obtain the corresponding pharmacokinetic parameters;

    Measured: 312 hours

  2. Area under the plasma concentration versus time curve (AUC) of HEC-585 and its major metabolites

    Analyze the Area under the plasma concentration versus time curve (AUC) of HEC-585 and its major metabolites (if applicable) to obtain the corresponding pharmacokinetic parameters;

    Measured: 312 hours

  3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    To investigate the safety and tolerability of HEC585 by assessment of Incidence of Treatment-Emergent Adverse Events following administration of of oral dose of 200 mg/100 µCi[14C]-HEC-585

    Measured: 504 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2022
  2. Study start26 Jul 2022
  3. Primary completion14 Aug 2022
  4. Study completion29 Aug 2022

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05468346
Sponsor's protocol ID
HEC585-IPF-103
Status last verified
Apr 2023
First submitted
12 May 2022
Last updated
13 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hutchinson J, Fogarty A, Hubbard R, McKeever T. Global incidence and mortality of idiopathic pulmonary fibrosis: a systematic review. Eur Respir J. 2015 Sep;46(3):795-806. doi: 10.1183/09031936.00185114. Epub 2015 May 14.

    PubMed 25976683

  • Olson AL, Gifford AH, Inase N, Fernandez Perez ER, Suda T. The epidemiology of idiopathic pulmonary fibrosis and interstitial lung diseases at risk of a progressive-fibrosing phenotype. Eur Respir Rev. 2018 Dec 21;27(150):180077. doi: 10.1183/16000617.0077-2018. Print 2018 Dec 31.

    PubMed 30578336

  • Richeldi L, Rubin AS, Avdeev S, Udwadia ZF, Xu ZJ. Idiopathic pulmonary fibrosis in BRIC countries: the cases of Brazil, Russia, India, and China. BMC Med. 2015 Sep 24;13:237. doi: 10.1186/s12916-015-0495-0.

    PubMed 26399999

  • Ingegnoli F, Ughi N, Mihai C. Update on the epidemiology, risk factors, and disease outcomes of systemic sclerosis. Best Pract Res Clin Rheumatol. 2018 Apr;32(2):223-240. doi: 10.1016/j.berh.2018.08.005. Epub 2018 Sep 14.

    PubMed 30527428

  • Hoffmann M, Kasserra C, Reyes J, Schafer P, Kosek J, Capone L, Parton A, Kim-Kang H, Surapaneni S, Kumar G. Absorption, metabolism and excretion of [14C]pomalidomide in humans following oral administration. Cancer Chemother Pharmacol. 2013 Feb;71(2):489-501. doi: 10.1007/s00280-012-2040-6. Epub 2012 Dec 1.

    PubMed 23203815

  • Hoffmann M, Kumar G, Schafer P, Cedzik D, Capone L, Fong KL, Gu Z, Heller D, Feng H, Surapaneni S, Laskin O, Wu A. Disposition, metabolism and mass balance of [(14)C]apremilast following oral administration. Xenobiotica. 2011 Dec;41(12):1063-75. doi: 10.3109/00498254.2011.604745. Epub 2011 Aug 23.

    PubMed 21859393

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]-HEC585 in people with Healthy Volunteer, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

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 4 inclusion and 23 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 13 Apr 2023. 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 China. 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?

Mass balance (time frame: plasma up to 312 hours post dose, urine and fecal samples up to 504 hours post dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05468346, which also lists 6 linked publications.

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 13 Apr 2023.

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