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PharmacokineticsPhase 1NCT05517616

The Absorption, Metabolism and Excretion of [14C]APG-2575 in Healthy Subjects

A Phase 1 study testing [14C ]APG-2575 in people with Pharmacokinetics, run by Ascentage Pharma Group Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a single-center, open-label, single-dose clinical pharmacokinetic study. The purpose of this study is to investigate the absorption properties, as well as to evaluate the mass balance and elucidate the pathways of biotransformation after a single oral dose of 400mg, 200μCi [14C] APG-2575 to healthy… Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pharmacokinetics
What is being tested?
[14C ]APG-2575
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
14 Sep 2022to 20 Apr 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 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy non-lactating female subjects aged 18-50 (including the boundary value) who have no reproductive needs during the study period and one year after taking the drug;
  • The weight is over 45 kg, and the body mass index (BMI) is between 19 and 26 kg/m2 (including the boundary value);
  • The result of the pregnancy test during the screening period must be negative;
  • The subjects participating in this trial should take effective contraceptive measures with their sexual partners during the study and within 1 year after the end of the research;
  • Subjects must sign the informed consent form voluntarily, agree to abide the requirements of the study protocol.

Who cannot join

  • After a comprehensive physical examination, vital signs, laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, stool routine, thyroid function), 12-lead electrocardiogram, chest CT, abdominal B-ultrasound (liver, gallbladder, pancreas, spleen and kidney) and other examinations are abnormal and have clinical significance;
  • Resting-corrected QT interval (QTcB) ≥ 450 ms obtained from a twelve-lead electrocardiogram (ECG);
  • Hepatitis B surface antigen or E antigen, hepatitis C virus antibody IgG (Anti-HCV IgG), human immunodeficiency virus antigen/antibody combined test (HIV-Ag/Ab) and Treponema pallidum antibody test positive;
  • The abnormal C-reactive protein of the new coronavirus infection screening has clinical significance or the new coronavirus nucleic acid is positive;
  • Use of any drug that inhibits or induces liver drug metabolizing enzymes within 30 days prior to the screening period
  • Use of any prescription drugs, over-the-counter drugs, herbal medicines, or food supplements, such as vitamins, calcium supplements, within 14 days prior to the screening period;
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  • Have any history of clinical serious diseases or diseases or conditions that the investigator considers to be likely to affect the results of the trial , including but not limited to circulatory system, respiratory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic medical history;
  • Reported history or presence of swallowing dysfunction, active gastrointestinal diseases or other diseases that significantly affect drug absorption, distribution, metabolism and excretion;
  • History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsades, ventricular tachycardia, atrioventricular block, QT prolongation History of syndrome or symptoms of QT prolongation syndrome and family history (as evidenced by genetic evidence or sudden death of close relatives due to cardiac causes at a young age);
  • Major surgery or surgical incision was not completely healed within 6 months before the screening period; major surgery includes but no limited to any surgery with significant bleeding risk, prolonged general anesthesia, or incisional biopsy or obvious traumatic injury;
  • Allergic constitution, such as those with known history of allergies to two or more substances; or, according to the investigator's judgment, may be sensitive to the investigational drug or its excipients (polyethylene glycol 400, Kolliphor EL, Labrasol, propylene glycol, sodium hydroxide, citric acid;
  • Hemorrhoids or perianal disease with regular/hematochezia, irritable bowel syndrome, inflammatory bowel disease;
  • Habitual constipation or diarrhea;
  • Binge drinking or frequent alcohol consumption within 6 months prior to the screening period, i.e. drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine); or during the screening period Alcohol breath test results > 20 mg/100 mL;
  • Those who smoked more than 5 cigarettes per day or habitually used nicotine-containing products in the first 3 months of the screening period, and were unable to quit during the trial;
  • Drug abuse or use of soft drugs (such as marijuana) 3 months before the screening period or hard drugs (such as cocaine, amphetamines, phencyclidine, etc.) 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 beverages and cannot quit during the trial;
  • Workers who need to be exposed to radiation for a long time; or have significant radiation exposure (≥2 chest/abdominal CT, or ≥3 other types of X-ray examinations) or participated in clinical trail of radioactivity within 1 year prior to this study.
  • Those with a history of fainting of needles or blood, those with difficulty in blood collection or those who cannot tolerate venipuncture for blood collection;
  • Participated in any other clinical trials (including clinical trials of drugs and devices) within 3 months before the screening period;
  • Those who have been vaccinated within 1 month before screening or who plan to be vaccinated during the study;
  • Those 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 with any factors considered inappropriate by the investigator to participate in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000

Other trials in China

About this study

Official title: A Single-center, Open-label, Single-dose Phase 1 Clinical Study to Investigate the Absorption, Metabolism and Excretion of APG-2575 in Healthy Subjects After Oral Administration of 400 mg/200 µCi [14C] APG-2575 Solution

This study is a single-center, open-label, single-dose clinical pharmacokinetic study. The purpose of this study is to investigate the absorption properties, as well as to evaluate the mass balance and elucidate the pathways of biotransformation after a single oral dose of 400mg, 200μCi [14C] APG-2575 to healthy subjects.

Being tested
[14C ]APG-2575

What participants receive

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

  • [14C ]APG-2575Drug

    orally, single dose of 400 mg / 200 μCi [14C] APG-2575

Study groups in NCT05517616
Study groupRoleWhat they receive
[14C]APG-2575ExperimentalTo investigate the absorption properties, as well as to evaluate the mass balance and elucidate the pathways of biotransformation after a single oral dose of 400mg, 200μCi [14C] APG-2575 to healthy subjects.
Receives: Drug: [14C ]APG-2575

What is being measured

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

  1. Radioactivity concentration of each blood and plasma sample

    Use liquid scintillation counter to evaluate Radioactivity concentration of each blood and plasma sample.

    Measured: Day 1- Day 8

  2. Radioactivity concentration in each urine and feces sample.

    Use liquid scintillation counter to evaluate Radioactivity concentration of each sample.

    Measured: Day 1- Day 15

  3. Number of metabolites and its proportion in plasma, urine and feces.

    To elucidate the pathways of biotransformation.

    Measured: Day 1- Day 15

Secondary outcomes (2)

  1. Plasma drug concentrations

    To determine the plasma concentrations of APG-2575 with LC-MS/MS.

    Measured: Day 1- Day 8

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

    According to CTCAE v5.0, the number and frequency of adverse events after a single dose of test drug were assessed.

    Measured: Day 1- Day 15

Timeline

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

  1. First posted26 Aug 2022
  2. Study start14 Sep 2022
  3. Primary completion1 Nov 2022
  4. Study completion20 Apr 2023

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05517616
Sponsor's protocol ID
APG2575XU104
Status last verified
Jan 2024
First submitted
22 Aug 2022
Last updated
23 Jan 2024
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 [14C ]APG-2575 in people with Pharmacokinetics, run by Ascentage Pharma Group Inc. 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 23 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: finished, as of the sponsor's last update on 23 Jan 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radioactivity concentration of each blood and plasma sample (time frame: Day 1- Day 8). 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 NCT05517616.

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 23 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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