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Small Cell Lung CancerPhase 1NCT07132957

A Study of AL8326 in Healthy Subjects

A Phase 1 study testing 14C-labeled AL8326 in people with Small Cell Lung Cancer and Solid Tumors, run by Advenchen Laboratories Nanjing Ltd. 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 experiment plans to enroll 6-8 healthy male subjects in China, and ultimately collect complete test samples and data from at least 6 subjects as the standard. On the first day of the experiment, each subject orally took a single dose of [14C] AL8326 oral formulation containing approximately 60mg (200 μ Ci). Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Small Cell Lung Cancer, Solid Tumors
What is being tested?
14C-labeled AL8326
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
21 Feb 2025to 17 May 2025
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

  • Subjects must meet all of the following inclusion criteria to be eligible for this study:
  • Chinese healthy male subjects, 18 to 45 years of age (inclusive)
  • Body mass index (BMI) of 19-26 kg/m2 (inclusive), and body weight not less than 50 kg (inclusive)
  • Subjects who had no fertility or sperm donation plan from signing the informed consent until 1 year after the end of the trial, or those who agreed that the subjects and their partners should strictly use contraception from signing the informed consent until 1 year after the end of the trial; Voluntarily signing the ICF，Ability to communicate well with the investigator and compliance to complete the trial according to the protocol.

Who cannot join

  • Subjects presenting with any of the following will not be included in the study:
  • Clinically significant abnormality of physical examination, vital signs, routine laboratory tests (hematology, blood chemistry, coagulation, urinalysis, and stool routine + occult blood), 12-lead ECG, chest X-ray (anterograde), digital anal examination, thyroid function,ophthalmic examination and abdomen ultrasound (liver, gallbladder, pancreas, spleen, and kidneys), etc.
  • Subjects with an allergic constitution, such as known allergic history to two or more substances, or allergic diseases, or those who may be hypersensitive to the investigational drug or its excipients, as judged by the investigator;
  • Gastrointestinal diseases causing clinically significant symptoms such as nausea, vomiting, diarrhea, or malabsorption syndrome; Or a history of severe vomiting or diarrhea within one week before the screening period;
  • History of dysphagia or any condition that may affect drug absorption (e.g., gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy);
  • History of any clinical critical illness or presence of diseases or conditions that the investigator considers may affect the trial results, including but not limited to diseases of digestive system, circulatory system, respiratory system, endocrine system, nervous system, urinary system or blood, immune system, psychiatric system and metabolism and nutrition diseases ;
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  • History of organic heart disease, heart failure, myocardial infarction, angina pectoris, torssion ventricular tachycardia, ventricular tachycardia, long QT syndrome or family history (genetic proof or sudden death of a close relative at a young age);
  • Major surgery within 6 months before screening or incomplete healing of surgical incision, the major surgeries including but not limited to any procedures that have significant risk of hemorrhage, prolonged general anesthesia, open biopsy, or marked traumatic invasive injury;
  • History of active bleeding (e.g., peptic ulcer, intracranial hemorrhage, skin ecchymosis, gingival bleeding); History of any disease within the previous 6 months that may increase the risk of bleeding (such as tumor bleeding, spontaneous hematoma, eye bleeding, hemoptysis, gastrointestinal bleeding or ulcers,hematuria,reproductive system bleeding, traumatic hematoma/bleeding, and frequent epistaxis/gingival bleeding/subcutaneous or skin bleeding) were screened.
  • Hemorrhoids or perianal diseases with regular/current hematochezia;
  • Hepatitis B surface antigen , hepatitis C virus antibody IgG test, human immunodeficiency virus antigen/antibody combination test, or Treponema pallidum antibody test is positive
  • Use of any drug that affects drug metabolism enzymes or transporters (P-gp and BCRP) in the 30 days prior to screening, as detailed in Appendix 5;
  • Have taken any prescription drugs, over-the-counter drugs, Chinese herbs or food supplements (vitamins, calcium supplements) in the 14 days prior to screening and before dosing;
  • Participation in any other clinical trial (including drug and device clinical trials) within 3 months before screening;
  • Habitual constipation or diarrhea;
  • History of blood loss or donation (≥400mL) within 3 months before screening, received a transfusion or blood component within 1 month, or planned to donate blood within 3 months after the end of the trial;
  • Daily smoking exceeding 5 cigarettes (≥ 5 cigarettes) within 3 months before Screening, or habitual use of nicotine-containing products and inability to withdraw during the trial period;
  • Alcoholism or frequent alcohol use within 6 months before screening, i.e., weekly alcohol consumption > 14 units (1 unit = 360 mL of beer or 45 mL of ABV 40% spirit or 150 mL of wine),Or alcohol breath test >20mg/dL，or unable to abstain during the test
  • Drug abuse, use of soft drug (e.g., marijuana) within 3 months before screening, or use of hard drug (e.g., cocaine, amphetamines, phencyclidine, etc.) within 1 year before screening; or positive urine drug test at screening;
  • Habitual or excessive (more than 8 cups a day, 1 cup =250mL) consumption of grapefruit juice, tea, coffee and/or caffeinated beverages, and unable to abstain during the trial period;
  • Those who have special requirements for diet and cannot abide by the uniform diet;
  • History of long-term exposure to radioactive conditions, or significant radiation exposure (≥2 chest/abdominal CT, or ≥3 other kinds of X-ray examinations) within 1 year before administration, or participating in radiopharyngology labeling tests;
  • History of needle fainting and blood fainting, difficulty in blood collection or inability to tolerate venous puncture blood collection;
  • Vaccinated within 1 month before screening or planned to be vaccinated during the trial period;
  • Subjects who with poor adherence or have any factors that make them not suitable for participating in this trial, as assessed by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

Other trials in China

About this study

Official title: A Phase I Study to Evaluate the Mass Balance of 14C-labeled AL8326 in Healthy Subjects

This experiment plans to enroll 6-8 healthy male subjects in China, and ultimately collect complete test samples and data from at least 6 subjects as the standard. On the first day of the experiment, each subject orally took a single dose of [14C] AL8326 oral formulation containing approximately 60mg (200 μ Ci). During the experiment, whole blood, plasma, urine, and fecal samples were collected at designated time points/time periods.

Read the detailed description

This experiment adopts a single center, open label, non randomized, single dose trial design. By measuring the total radioactivity, calculate the ratio of total radioactivity in whole blood to plasma of [14C] AL8326, pharmacokinetic parameters, recovery rate, and excretion pathway data of total radioactivity in plasma. At the same time, by identifying the spectra of radioactive metabolites and the structures of major metabolites in plasma, urine, and feces, the main metabolic elimination pathways and characteristics of AL8326 in the human body were obtained, as well as the circulating metabolites that are close to or higher than 10% of the total radioactive exposure in plasma.

Being tested
14C-labeled AL8326
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • 14C-labeled AL8326Drug

    Oral, About 60mg (200μCi) of 14C-labeled AL8326

Study groups in NCT07132957
Study groupRoleWhat they receive
14C-labeled AL8326ExperimentalSingle dose
Receives: Drug: 14C-labeled AL8326

What is being measured

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

  1. Material balance

    the cumulative excretion rate of total radioactive material in excreta (urine and feces);

    Measured: All excreted urine and feces samples at specified time points during 0-480 hours after dosing will be collected.

  2. Metabolites

    The percentage of the original drug and each metabolite in urine and feces (% dose)

    Measured: Conduct testing within 1 month after all subjects collect plasma, urine, and fecal samplesat all time points required by the protocol

  3. Metabolites

    The AUC percentage of the original drug and circulating metabolites in plasma (%AUC) were calculated;

    Measured: Conduct testing within 1 month after all subjects collect plasma samplesat all time points required by the protocol

  4. Pharmacokinetic

    Pharmacokinetic parameters for total radioactivity in plasma， including peak concentration (Cmax), time to peak (Tmax), area under the drug-time curve (AUC0-t and AUC0-∞), elimination half-life (t1/2), apparent clearance (CL/F), apparent volume of distribution (Vd/F) and mean residence time (MRT). ) and mean residence time (MRT).

    Measured: Conduct testing within 1 month after all subjects collect plasma samplesat all time points required by the protocol

  5. whole blood

    whole blood to plasma total radioactivity partition ratio

    Measured: Conduct testing within 1 month after all subjects collect plasma samplesat all time points required by the protocol

Secondary outcomes (2)

  1. Plasma pharmacokinetics

    PK parameters of AL8326 and its main metabolites in plasma， including peak concentration (Cmax), time to peak (Tmax), area under the drug-time curve (AUC0-t and AUC0-∞), elimination half-life (t1/2), apparent clearance (CL/F), apparent volume of distribution (Vd/F) and mean residence time (MRT). ) and mean residence time (MRT).

    Measured: Conduct testing within 1 month after all subjects collect plasma, urine, and fecal samplesat all time points required by the protocol

  2. Safety

    Number of participants with adverse events/drug-related adverse events, with abnormal physical examination findings, abnormal vital signs, abnormal 12-lead electrocardiogram, and abnormal laboratory tests results

    Measured: From signing the ICF until 22 days after the first dosing

Timeline

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

  1. First posted20 Aug 2025
  2. Study start21 Feb 2025
  3. Primary completion17 May 2025
  4. Study completion17 May 2025

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
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07132957
Sponsor's protocol ID
AL8326-CN-011
Status last verified
Aug 2025
First submitted
19 Feb 2025
Last updated
20 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 14C-labeled AL8326 in people with Small Cell Lung Cancer and Solid Tumors, run by Advenchen Laboratories Nanjing 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 4 inclusion and 25 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 20 Aug 2025. 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?

Material balance (time frame: All excreted urine and feces samples at specified time points during 0-480 hours after dosing will be collected.). The study lists 5 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 NCT07132957.

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 20 Aug 2025.

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