Mass Balance and Biotransformation Study of [14C]DBPR108 in Human

NCT05072028 | Completed Phase 1

• 1 other identifier: HA1118-CSP-011
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label phase I clinical study to evaluate the mass balance and biotransformation pathways of \[14C\]DBPR108 in Chinese healthy adult male subjects, to reveal the overall pharmacokinetic characteristics of DBPR108 in human body, and to provide a reference for the rational administration.

Conditions

Healthy Male Subjects

Outcome Measures

Primary Outcomes (5)

• Total radioactivity in urine and feces

  From time zero up to 240 hours post-dose following oral administration of [14] DBPR108

• Peak plasma concentration (Cmax)

  From time zero up to 96 hours post-dose following oral administration of [14] DBPR108

• Area under the plasma concentration versus time curve from time zero to the last measurable concentration (AUClast)

  From time zero up to 96 hours post-dose following oral administration of [14] DBPR108

• Area under the plasma concentration versus time curve from time zero to infinity (AUCinf)

  From time zero up to 96 hours post-dose following oral administration of [14] DBPR108

• Time to achieve maximum plasma concentration (Tmax)

  From time zero up to 96 hours post-dose following oral administration of [14] DBPR108

Secondary Outcomes (1)

• Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0

  From time zero up to 240 hours post-dose following oral administration of [14] DBPR108

Study Arms (1)

[14C]DBPR108

EXPERIMENTAL

Subjects will receive a single oral 100 mg (radioactivity of 150 µCi) dose of \[14C\]DBPR108 on Day 1.

Drug: [14C]DBPR108

Interventions

[14C]DBPR108 DRUG

\[14C\]DBPR108, single dose of 100 mg (radioactivity of 150 µCi), oral

[14C]DBPR108

Eligibility Criteria

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

You may qualify if:

• Healthy male adults;
• to 45 years (inclusive);
• Subjects weight ≥50.0 kg and body mass index (BMI) between18-26 kg/m\^2 (inclusive) (BMI= weight (kg)/height\^2 (m\^2);
• Medical history, vital signs examination, physical examination, laboratory tests (blood routine, blood biochemistry, urine routine, thyroid function) and other test results of subjects judged to be normal or abnormal without clinical significance;
• Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions.

You may not qualify if:

• Clinically significant abnormal results for physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, coagulation routine, urine routine, stool routine + occult blood, thyroid function, glycated hemoglobin), 12-lead electrocardiogram (ECG), chest CT scan, and abdominal B-ultrasound (liver, gallbladder, pancreas, spleen, and kidney);
• Any positive test result of hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti-Treponema pallidum specific antibody;
• Subjects with a history of severe hypoglycemia, such as drowsiness, disturbance of consciousness, or even coma due to hypoglycemia;
• History of acute and chronic pancreatitis, or a history of cholecystitis, gallstones, and pancreatic injury and other high-risk factors that may cause pancreatitis;
• Subjects are hard to swallow, or have diseases affecting drug absorption, distribution, metabolism, excretion;
• History of gastrointestinal ulcer or bleeding;
• History of any clinically significant diseases, such as circulatory, endocrine, neurological, gastrointestinal, urinary, hematological, immunological, psychiatric and metabolic diseases;
• History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsade de pointes ventricular tachycardia, ventricular tachycardia, prolonged QT syndrome, or symptoms of prolonged QT syndrome and family history;
• Have a major surgery or incomplete incision healing within 6 months prior to screening. Major surgery includes, but is not limited to, any surgery involving a significant risk of bleeding, prolonged general anesthesia, or open biopsy or obvious traumatic injury;
• History of needle sickness or blood sickness, difficulty in blood collection or intolerance to venipuncture blood collection;
• Have hemorrhoids or perianal disease with regular/ongoing bleeding stools;
• Have habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease;
• Have a history of allergic conditions, or have a history of allergy to any of DBPR108 or other similarly structured drugs. Those who cannot follow a uniform diet.
• Subjects are lactose intolerant or have rare genetic galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption;
• Use of any metabolizing enzyme inducers or inhibitors within 30 days prior to screening;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

First Affiliated Hospital of Soochow University

Suzhou, China

Location

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: September 29, 2021
• First Posted: October 8, 2021
• Study Start: November 16, 2021
• Primary Completion: November 28, 2021
• Study Completion: November 28, 2021
• Last Updated: January 3, 2022

Record last verified: 2021-09

Locations

CN (1)