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Chronic Kidney DiseasesPhase 1NCT05675202

Material Balance Study of TQ-B3525

A Phase 1 study testing TQ-B3525 in people with Chronic Kidney Diseases and Magnetic Resonance Imaging, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A clinical study to investigate the absorption, metabolism and excretion of [14C] TQ-B3525 in Chinese adult male healthy subjects, aiming to quantitatively analyze the total radioactivity in the excreta of male healthy subjects after oral administration of [14C] TQ-B3525, obtain the data of human radioactive excretion… Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
What is being tested?
TQ-B3525
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteChina
Study dates
Jan 2023to Dec 2023
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 adult male;
  • Age: 18-45 years old (including boundary value);
  • Body weight: Body mass index (BMI) is between 19 and 26 kg/m2 (including the boundary value), and the weight of the subject is not less than 50 kg;
  • Sign the informed consent form voluntarily;
  • The subjects were able to communicate well with the researchers and complete the trial according to the protocol.

Who cannot join

  • Those with abnormal and clinically significant results from comprehensive physical examination, vital signs, routine laboratory examination (blood routine examination, blood biochemistry, blood coagulation function, urine routine examination, stool routine examination, glycosylated hemoglobin, lipase, amylase), thyroid function, 12 lead ECG, chest CT, abdominal B ultrasound (liver, gallbladder, pancreas, spleen and kidney), etc;
  • Abnormal ophthalmic examination (slit lamp, intraocular pressure and fundus photography) with clinical significance;
  • Hepatitis B surface antigen or E antigen, anti HCV IgG, HIV Ag/Ab and Treponema pallidum antibody positive;
  • Cytomegalovirus (CMV) antibody positive;
  • Novel coronavirus nucleic acid positive;
  • Any drugs that inhibit or induce liver drug metabolizing enzymes were used within 30 days before the screening period (see Appendix 1 for details);
Show all 27Show fewer
  • Have used any prescription drugs, over-the-counter drugs, Chinese herbal medicine or food supplements, such as vitamins and calcium supplements, within 14 days before the screening period;
  • Any serious clinical disease history or any disease or circumstance that the researcher thinks may affect the test results, including but not limited to the history of circulatory system, respiratory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic diseases;
  • People with any disease that increases the risk of elevated blood sugar, such as those with a history of primary diabetes, steroid induced diabetes or other secondary diabetes, and those with acute or chronic pancreatitis;
  • People who have a history of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, history of torsade, ventricular tachycardia, atrioventricular block, history of prolonged QT syndrome, or symptoms of prolonged QT syndrome and family history (certified by genetics or sudden death of a close relative due to cardiac causes when young);
  • History of interstitial lung disease, severe impairment of lung function, severe pulmonary fibrosis, radiation pneumonitis, drug-induced lung disease, and chest CT findings during screening period suggest evidence of active pulmonary inflammation;
  • Major surgery or incomplete healing of surgical incision within 6 months before the screening period; Major surgery includes, but is not limited to, any surgery with significant bleeding risk, extended general anesthesia period, or open biopsy or obvious traumatic injury;
  • Allergic constitution, such as known history of allergy to two or more substances; Or the investigator may be allergic to the test drug or its excipients;
  • Hemorrhoids or perianal diseases, irritable bowel syndrome, inflammatory bowel disease with regular/ongoing blood in the stool;
  • People with multiple factors affecting oral administration and drug absorption (such as inability to swallow, gastrointestinal resection, ulcerative colitis, symptomatic/inflammatory bowel disease, intestinal obstruction, etc.); habits and customs:
  • Habitual constipation or diarrhea;
  • Excessive drinking or regular drinking within 6 months before the screening period, that is, drinking more than 14 units of alcohol every week (1 unit=360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine); Or the results of alcohol breath test during screening period ≥ 20 mg/dl;
  • Those who smoke more than 5 cigarettes a day or habitually use nicotine containing products in the first 3 months of the screening period and cannot quit during the trial period;
  • Abuse of drugs or use of soft drugs (such as marijuana) 3 months before the screening period or use of hard drugs (such as cocaine, amphetamines, and phencyclidine) 1 year before the screening period; Or positive urine drug test during screening period;
  • Those who habitually drink grapefruit juice or excessive tea, coffee and/or caffeinated drinks, and cannot give up during the test; other:
  • Workers who need to be exposed to radioactive conditions for a long time; Or those who have significant radiation exposure (≥ 2 chest/abdomen CT, or ≥ 3 other kinds of X-ray examinations) or participated in the radiopharmaceutical labeling test within 1 year before the test;
  • Those who have a history of needle fainting and blood fainting, and who have difficulty in blood collection or can not tolerate venous puncture blood collection;
  • Participated in any other clinical trials (including drug and device clinical trials) within 3 months before the screening period;
  • Those who have been vaccinated within one month before screening or who plan to be vaccinated during the trial period;
  • hose who have fertility or sperm donation plans during the trial and within one year after the completion of the trial, or those who do not agree that the subject and his/her spouse should take strict contraceptive measures during the trial and within one year after the completion of the trial (see Appendix 3 for details);
  • People who have lost blood or donated blood up to 400 mL within 3 months before the screening period, or received blood transfusion within 1 month;
  • Subjects who are considered by the researcher to have any factors unsuitable for this experiment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Liyan Miao, Master of Medicine, +86 13862592687, miaolysuzhou@163.com

Other trials in China

About this study

Official title: Clinical Trial on Absorption, Metabolism and Excretion of [14C] TQ-B3525 in Chinese Adult Male Healthy Subjects - Research on Material Balance and Biotransformation of [14C] TQ-B3525

A clinical study to investigate the absorption, metabolism and excretion of [14C] TQ-B3525 in Chinese adult male healthy subjects, aiming to quantitatively analyze the total radioactivity in the excreta of male healthy subjects after oral administration of [14C] TQ-B3525, obtain the data of human radioactive excretion rate and main drainage routes, investigate the distribution in whole blood and plasma, the distribution in plasma and the pharmacokinetics of total radioactivity in plasma, and identify the main metabolites, To determine the main biotransformation pathway and obtain the pharmacokinetic parameters of TQ-B3525 and its metabolites in plasma.

Being tested
TQ-B3525
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

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

  • TQ-B3525Drug

    TQ-B3525 is a new PI3K α/δ Kinase inhibitor

Study groups in NCT05675202
Study groupRoleWhat they receive
TQ-B3525 tabletExperimental100 µ Ci [14C] TQ-B3525, 20mg, once in total
Receives: Drug: TQ-B3525

What is being measured

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

  1. Peak concentration (Cmax)

    Maximum plasma drug concentration

    Measured: Before administration, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, 336 hours after administration

  2. Area under drug time curve (AUC 0-t)

    Area under the plasma concentration time curve from time 0 to last time of quantifiable concentration

    Measured: Before administration, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, 336 hours after administration

  3. Area under drug time curve (AUC 0-last)

    Area under the plasma concentration-time curve from time 0 extrapolated to infinite time

    Measured: Before administration, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, 336 hours after administration

Secondary outcomes (1)

  1. Incidence rate of adverse events

    Record the number of cases, time of adverse events, including the abnormal changes in in physical examination, vital signs, 12 lead ECG, laboratory test values and other indicators.

    Measured: Before the first administration until it returns to normal or the level considered acceptable by the investigator

Timeline

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

  1. First posted9 Jan 2023
  2. Study startJan 2023 (estimated)
  3. Primary completionAug 2023 (estimated)
  4. Study completionDec 2023 (estimated)

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
8 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05675202
Sponsor's protocol ID
TQ-B3525-I-04
Status last verified
Aug 2022
First submitted
29 Dec 2022
Last updated
12 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TQ-B3525 in people with Chronic Kidney Diseases and Magnetic Resonance Imaging, run by Chia Tai Tianqing Pharmaceutical Group 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 5 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 12 Jan 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak concentration (Cmax) (time frame: Before administration, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, 336 hours after administration). The study lists 3 primary outcomes in all. 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 NCT05675202.

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 12 Jan 2023.

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