AzTrials
AzTrials

Solid TumorPhase 1NCT07030439

A Bioequivalence Study to Compare Senaparib Manufactured at 2 Sites in Healthy Subjects in Fasting State

A Phase 1 study testing Senaparib 10 mg strength capsules manufactured by WuXi STA (Wuxi) Co., Ltd. and Senaparib 10 mg strength capsules manufactured by WuXi STA (Shanghai) Co., Ltd. in people with Solid Tumor, run by Impact Therapeutics, 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
Search all trials

Trial summary

An Open-label, Randomized, Single-dose, Two-way Crossover Study to Compare the Bioequivalence of Senaparib 10 mg Capsules Manufactured at Different Manufacturing Sites After Administration in Fasting State in Healthy Chinese Subjects Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Solid Tumor
What is being tested?
Senaparib 10 mg strength capsules manufactured by WuXi STA (Wuxi) Co., Ltd. and Senaparib 10 mg strength capsules manufactured by WuXi STA (Shanghai) Co., Ltd.
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
18 Jul 2021to 12 Oct 2021
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 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects fully understood the purpose, nature, methods and possible adverse reactions of the trial, voluntarily participated in the trial, and signed an informed consent form before any trial procedure, and promised to participate in all procedure of the trial.
  • Healthy Chinese male subjects aged 18 to 55 (inclusive) at screening.
  • Body mass index (BMI) ranged from 19.0 to 26.0 kg/m2 (inclusive); body weight ≥ 50.0 kg.
  • Subjects could communicate well with the investigators and understood and abided by the requirements of this trial.

Who cannot join

  • Subjects with diseases with clinical abnormality, including but not limited to disease concerning nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolic system and skeletal system.
  • Subjects with allergic history (including drug and food allergies, etc.).
  • Subjects with history of dysphagia or any gastrointestinal disease that affected drug absorption judged by the investigator.
  • Subjects who had received surgery within 3 months before screening, or planned to have surgery during the trial, or those who had previous surgery that would affect drug absorption (e.g. gastrectomy).
  • Subjects who could not tolerate venipuncture, or had a history of needlesickness and fainting at the sight of blood.
  • Subject with lactose intolerability (who having had milk diarrhea).
Show all 26Show fewer
  • Subjects who had drug abuse history within 6 months before screening, or had a positive urine drug screening (screening or baseline period) result.
  • Subjects who consumed more than 14 units of alcohol per week (1 unit of alcohol = 360 mL beer, 150 mL wine, or 45 mL liquor) within 3 months before screening, or who had a positive result of alcohol breath test (screening or baseline period), or could not give up alcohol during the trial.
  • Subjects who consumed an average of more than 5 cigarettes per day within 3 months before screening, or who could not stop using any tobacco products during the trial.
  • Subjects who consumed an average of excessive amounts of tea, coffee and / or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) every day within 3 months before screening.
  • Subjects who had participated in clinical trials of other study drugs/devices within 3 months before the first dose of the investigational drug, or had participated in 3 or more clinical trials of drugs/devices in the past year; if other study drugs had a longer half-life, the time interval would be longer and was required to be 5 half-lives of the drug.
  • Subjects who donated blood including blood component or had massive blood loss (≥ 200 mL), or received blood transfusion or used blood products and blood biological products within 3 months before screening.
  • Subjects who received live vaccines within 4 weeks before screening.
  • Subjects who had taken any drugs [such as: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; SSRI(selective serotonin reuptake inhibitor) antidepressants, cimetidine, macrolides, sedative hypnotics, antihistamines, antivirals (such as saquinavir), calcium antagonists (such as diltiazem, verapamil), rifamycins (such as rifampicin)] that potently inhibit or induce CYP3A4 enzymes within 28 days before the use of the investigational drug. If the past drug used had a longer half-life, the time interval would be longer and was required to be 5 half-lives of the drug, e.g., phenobarbital required a 5-week washout period.
  • Subjects who had taken prescription drugs, over-the-counter drugs, dietary supplements or Chinese herbal medicine within 14 days before the first dose of the investigational drug. If the past drug used had a longer half-life, the time interval would be longer and was required to be 5 half-lives of the drug. Limited use of over-the-counter drugs that were not considered to affect the overall outcome of the study was allowed on a case-bycase basis after approval by the sponsor and the investigator.
  • Any test result of hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody was positive.
  • At screening, vital signs (blood pressure, pulse and body temperature) examination, comprehensive physical examination and laboratory tests (hematology, blood biochemistry, urinalysis) indicated abnormal results with clinical significance according to the investigator. The reference normal range of vital signs (including the cut-off value) was as follows: Sitting systolic blood pressure was 90 to 140 mmHg, diastolic blood pressure was 60 to 90 mmHg, pulse was 60 to 100 bpm, body temperature (ear temperature) was 35.7 to 37.9°C. The specific situation was comprehensively determined by the investigator.
  • At screening, the corrected QT interval (corrected by Fridericia's formula, QTcF = QT/RR1/3) > 450 msec or QRS complex > 120 msec was obtained by 12-lead ECG in supine position in resting state (at least 5 min). If QTc was more than 450 msec or QRS was more than 120 msec, ECG measurement should be repeated twice, and the average value of QTc or QRS measured three times was judged by the investigator as abnormality with clinical significance.
  • Subjects who were allergic to Senaparib, or to any ingredients of the preparation.
  • Vigorous exercise could not be avoided within 48 h before the first dose of the investigational drug and during the trial.
  • Subjects who consumed any food or beverages containing alcohol, caffeine, chocolate, or rich in xanthine within 48 h before the first dose of the investigational drug; or those who could not abstain from these products during the trial.
  • Subjects who could not abstain from grapefruit or grapefruit-related citrus (eg, pomelo) or juice within 7 days before the first dose of investigational drug and during the trial.
  • Subjects or its partners who had birth plan, or were unwilling to adopt effective contraception methods, or had sperm donation plan throughout the trial and within 90 days after the last dose of the investigational drug.
  • Subjects who were unwilling or unable to follow the lifestyle guidelines described in the study protocol (such as dietary restrictions and activity requirements).
  • Subjects who had other acute or chronic medical or psychiatric diseases, which may increase the risks of participating in this trial, or may interfere with the interpretation of the trial results, were judged unsuitable to participate in this trial by the investigator.
  • Subjects judged by the investigator to be unsuitable for participation in the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu

Other trials in China

About this study

Official title: An Open-label, Randomized, Single-dose, Two-way Crossover Study to Compare the Bioequivalence of Senaparib 10 mg Capsules Manufactured at Different Manufacturing Sites After Administration in Fasting State in Healthy Chinese Subjects

An Open-label, Randomized, Single-dose, Two-way Crossover Study to Compare the Bioequivalence of Senaparib 10 mg Capsules Manufactured at Different Manufacturing Sites After Administration in Fasting State in Healthy Chinese Subjects

Read the detailed description

An Open-label, Randomized, Single-dose, Two-way Crossover Study to Compare the Bioequivalence of Senaparib 10 mg Capsules Manufactured at Different Manufacturing Sites After Administration in Fasting State in Healthy Chinese Subjects.

32 Subjects are planned to be enrolled. At least, 26 subjects are planned to be completed.

Conditions
Solid Tumor
Being tested
Senaparib 10 mg strength capsules manufactured by WuXi STA (Wuxi) Co., Ltd., Senaparib 10 mg strength capsules manufactured by WuXi STA (Shanghai) Co., Ltd.

What participants receive

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

  • Senaparib 10 mg strength capsules manufactured by WuXi STA (Wuxi) Co., Ltd.Drug

    A single oral dose of 100mg of Senaparib 10 mg strength capsules manufactured by WuXi STA (Wuxi) Co., Ltd. (test product, manufactured at the new manufacturing site) administered in fasting state in first intervention period and then Senaparib 10 mg strength capsules manufactured by WuXi STA (Shanghai) Co., Ltd. (reference product, manufactured at the original manufacturing site) in second intervention period (after washout period: at least 7 days)

  • Senaparib 10 mg strength capsules manufactured by WuXi STA (Shanghai) Co., Ltd.Drug

    A single oral dose of 100mg of Senaparib 10 mg strength capsules manufactured by WuXi STA (Shanghai) Co., Ltd. (reference product, manufactured at the original manufacturing site) administered in fasting state in first intervention period and then Senaparib 10 mg strength capsules manufactured by WuXi STA (Wuxi) Co., Ltd. (test product, manufactured at the new manufacturing site) in second intervention period (after washout period: at least 7 days)

Study groups in NCT07030439
Study groupRoleWhat they receive
Senaparib capsules first new manufacturing site then original manufacturing siteExperimentalA single oral dose of 100mg of Senaparib 10 mg strength capsules manufactured by WuXi STA (Wuxi) Co., Ltd. (test product, manufactured at the new manufacturing site) administered in fasting state in first intervention period and then Senaparib 10 mg strength capsules manufactured by WuXi STA (Shanghai) Co., Ltd. (reference product, manufactured at the original manufacturing site) in second intervention period (after washout period: at least 7 days)
Receives: Drug: Senaparib 10 mg strength capsules manufactured by WuXi STA (Wuxi) Co., Ltd.; Drug: Senaparib 10 mg strength capsules manufactured by WuXi STA (Shanghai) Co., Ltd.
Senaparib capsules first original manufacturing site then new manufacturing siteExperimentalA single oral dose of 100mg of Senaparib 10 mg strength capsules manufactured by WuXi STA (Shanghai) Co., Ltd. (reference product, manufactured at the original manufacturing site) administered in fasting state in first intervention period and then Senaparib 10 mg strength capsules manufactured by WuXi STA (Wuxi) Co., Ltd. (test product, manufactured at the new manufacturing site) in second intervention period (after washout period: at least 7 days)
Receives: Drug: Senaparib 10 mg strength capsules manufactured by WuXi STA (Wuxi) Co., Ltd.; Drug: Senaparib 10 mg strength capsules manufactured by WuXi STA (Shanghai) Co., Ltd.

What is being measured

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

  1. Cmax

    Maximum concentration

    Measured: 0-72 hour

  2. AUC0-last

    Area under the curve from time 0 to the last time with quantifiable concentration

    Measured: 0-72 hour

  3. AUC0-inf

    If the data were available, area under the curve from time 0 to infinity

    Measured: 0-72 hour

Timeline

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

  1. First posted22 Jun 2025
  2. Study start18 Jul 2021
  3. Primary completion12 Oct 2021
  4. Study completion12 Oct 2021

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07030439
Sponsor's protocol ID
IMP4297-108
Status last verified
Jun 2025
First submitted
12 Jun 2025
Last updated
22 Jun 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 Senaparib 10 mg strength capsules manufactured by WuXi STA (Wuxi) Co., Ltd. and Senaparib 10 mg strength capsules manufactured by WuXi STA (Shanghai) Co., Ltd. in people with Solid Tumor, run by Impact Therapeutics, 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 4 inclusion and 26 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 22 Jun 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?

Cmax (time frame: 0-72 hour). 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 NCT07030439.

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 22 Jun 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in