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

NCT05468346 | Completed Phase 1 FDA Drug

• 1 other identifier: HEC585-IPF-103
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Mass balance

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

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

Secondary Outcomes (3)

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

  312 hours

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

  312 hours

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

  504 hours

Study Arms (1)

[14C]-HEC585

EXPERIMENTAL

\[14C\]-HEC585,solid powder，200 mg/100 µCi,single dose，oral

Drug: [14C]-HEC585

Interventions

[14C]-HEC585 DRUG

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

[14C]-HEC585

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Related Publications (6)

• 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.

  PMID: 25976683 BACKGROUND

• 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.

  PMID: 30578336 BACKGROUND

• 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.

  PMID: 26399999 BACKGROUND

• 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.

  PMID: 30527428 BACKGROUND

• 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.

  PMID: 23203815 BACKGROUND

• 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.

  PMID: 21859393 BACKGROUND

Related Links

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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 12, 2022
• First Posted: July 21, 2022
• Study Start: July 26, 2022
• Primary Completion: August 14, 2022
• Study Completion: August 29, 2022
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)