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NCT Number: NCT07612306

Material Balance Study of [14C] Flonoltinib Maleate

The primary objectives are: 1. To investigate the total radioactivity in urine and feces after a single oral administration of [14C]Flonoltinib in healthy adult male participants, thereby obtaining human radioactive recovery rates and the main excretion pathways;2.Examine the spectrum of radioactive metabolites in plasma, urine, and feces, identify the main metabolites, and elucidate the main biotransformation pathways of fluorotinib maleate in healthy adult male participants;3.Examine the total radioactivity in whole blood and plasma, evaluate the pharmacokinetic (PK) characteristics of total radioactivity in whole blood (if applicable) and plasma, and assess the distribution of total radioactivity in whole blood and plasma.

Secondary objective: 1. To quantitatively analyze the concentration of Flonoltinib Maleate in plasma using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) and evaluate the PK characteristics of Flonoltinib Maleate in plasma;2.Evaluate the safety and tolerability of [14C]Flonoltinib Maleate after a single oral administration in healthy adult male participants.

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Key information

Conditions

MF

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chinese healthy adult male, aged 18-45 years old
  • Participants weighing no less than 50 kg and having a body mass index (BMI) between 19.0 and 26.0 kg/m^2
  • Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and be able to complete the entire trial process according to the trial requirements.

Exclusion criteria

  • Screening period electrocardiogram examination: Fridericia formula (QTcF=QT/(RR ^ 0.33)) corrected QT interval (QTcF)>450 milliseconds
  • HBsAg,HBeAg, hepatitis C antibody, treponema pallidum antibody or HIV Ag/Ab combined test
  • Individuals with a history of drug abuse or drug use, or positive urine drug abuse screening results
  • Individuals who have consumed any food or beverage containing alcohol, grapefruit juice/grapefruit juice, or methylxanthine (such as coffee, tea, cola, chocolate, functional drinks) within 48 hours prior to check-in, and have engaged in vigorous exercise or other factors that affect drug absorption, distribution, metabolism, excretion, etc. Or those who are unable to stop eating any food or beverage containing alcohol, grapefruit juice/grapefruit juice, or methylxanthine (such as coffee, tea, cola, chocolate, functional drinks) during the trial period, and cannot avoid vigorous exercise or other factors that affect drug absorption, distribution, metabolism, excretion, etc
  • Engaged in workers who require long-term exposure to radioactive conditions, or have significant radiation exposure (>=2 chest/abdominal CT scans, or >= 3 other types of X-ray examinations) within 1 year before administration, or have participated in radiopharmaceutical labeling tests within 1 year
  • Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection

Treatment and study plan

Flonoltinib 75mg

Drug

Allocate 75mg /100 μCi[14C]flonoltinib once daily on an empty stomach

Primary outcomes

  1. Cumulative excretion rate of total radioactivity in urine and feces

    Time frame: Through 360 hours postdose

  2. Identify the main metabolites

    Time frame: Through 216 hours postdose

  3. Total radioactivity ratio in whole blood and plasma

    Time frame: Through 216 hours postdose

Secondary outcomes

  1. Cmax

    Time frame: Through 216 hours postdose

  2. Safety endpoint

    Time frame: From dosing (Day 0) through study completion (Day 16)

    Adverse events (AE)

  3. Tmax

    Time frame: Through 216 hours postdose

  4. AUC0-t

    Time frame: Through 216 hours postdose

  5. t1/2

    Time frame: Through 216 hours postdose

Study contacts

Contact information is provided by the study sponsor or research team.

Wang Fangmei

CONTACT

[email protected]

13808086495

Sponsors and collaborators

Lead sponsor

Chengdu Zenitar Biomedical Technology Co., Ltd

Industry

Registry information

Official study title

A Single-Center, Non-Randomized, Open-Label, Single-Dose Material Balance Study of [14C]Flonoltinib Maleate in Healthy Subjects

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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