ADME Study of [14C]-Jaktinib in Healthy Male Subjects

NCT05150717 | Completed Phase 1

• 1 other identifier: ZGJAK023
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to evaluate the mass balance and biotransformation after single-dose of \[14C\]-Jaktinib orally in Chinese healthy male subjects.

Conditions

Healthy Adult Male Volunteers

Outcome Measures

Primary Outcomes (2)

• Cumulative excretion of 14C-labeled drug-related material (radioactivity in urine and fecal samples)

  Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in urine and feces.

  From the start of administration to 240 hours after administration

• Identification of the Proportion of different metabolites to determine biotransformation pathway of Jaktinib

  Proportion of different metabolites(Jaktinib and main metabolites)

  From the start of administration to 240 hours after administration

Secondary Outcomes (2)

• Quantitive analysis of the concentrations of Jaktinib and main metabolites in plasma to obtain pharmacokinetic data

  From the start of administration to 240 hours after administration

• Adverse events

  From the start of administration to 17days after administration

Study Arms (1)

[14C]-Jaktinib

EXPERIMENTAL

Subjects will receive single dose of \[14C\]-Jaktinib (Suspension, 100mg/150μCi)

Drug: [14C]-Jaktinib

Interventions

[14C]-Jaktinib DRUG

Subjects will receive single dose of orally \[14C\]-Jaktinib on Day 1.

[14C]-Jaktinib

Eligibility Criteria

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

You may qualify if:

• Healthy Chinese males, aged 18-45 years old (inclusive);
• Body weight ≥ 50.0 kg, body mass index (BMI) between 19-26kg/m2 (inclusive);
• Sign the informed consent form；
• Participants are able to communicate well with the investigators and be able to complete the trial according to the Process.

You may not qualify if:

• Physical examination, vital signs, routine laboratory tests, 12-lead ECG, Chest X-ray, abdominal B-ultrasound and other is abnormal and clinically significant;
• Positive for hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody, or Treponema pallidum antibodies;
• Use of any prescription or over-the-counter drug, any vitamin product, health care drug or Chinese herbal medicine within 14 days prior to screening.
• Participants who have participated in any clinical trials within 3 months prior to screening and have used the test drug or medical devices.
• A history of any clinically serious illness or condition, including but not limited to circulatory, endocrine, nervous,digestive, urinary, or blood, immune, mental, and metabolic diseases, that the investigator considers to be likely to affect the results of the study.
• Participants who had heart disease such as heart failure, angina pectoris, myocardial infarction, and clinically significant arrhythmia.
• Participants who had undergone major surgery or whose surgical incision was not completely healed within 6 months before the screening period; Major surgery includes, but is not limited to, any surgery with a significant risk of bleeding, prolonged general anesthesia, or an open biopsy or significant traumatic injury.
• Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before screening.
• Hemorrhoids or perianal diseases with regular/bleeding in the stool; Patients with gastrointestinal dysfunction, such as irritable bowel syndrome and inflammatory bowel disease, may be affected by drug absorption as determined by researchers.
• Habitual constipation or diarrhea.
• Heavy drinking or regular drinking in the six months preceding the screening period, or alcohol breath test results ≥20 mg/dL during the screening period.
• Participants who had smoked more than 5 cigarettes per day on average in the 3 months before the screening period or habitually used nicotine-containing products and were unable to quit during the test period.
• Substance abuse or use of soft drugs (e.g., marijuana) in the 3 months prior to the screening period or use of hard drugs (e.g., cocaine, amphetamines, phenylcyclohexidine, etc.) in the 1 year prior to the screening period, or screening for positive urine drug abuse (drug) tests.
• Habitual consumption of grapefruit juice or excessive consumption of tea, coffee and/or caffeinated beverages and failure to abstain during the study period.
• Participants with a history of fainting needle or blood, have difficulty in blood collection or cannot tolerate vein puncture for blood collection.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

The First Affiliated Hospital of soochow University

Suzhou, Jiangsu, China

Location

Study Officials

• liyan Miao, PhD

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

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: November 24, 2021
• First Posted: December 9, 2021
• Study Start: January 4, 2022
• Primary Completion: January 30, 2022
• Study Completion: January 30, 2022
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

CN (1)