Solid TumorPhase 1NCT07019194

An Bioequivalence Study to Compare 10mg & 20mg of Senaparib Capsules in Healthy Chinese Subjects Under Fasting Condition

A Phase 1 study testing Senaparib capsules(20mg) and Senaparib capsules(10mg) 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

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Trial summary

An Open-label, Randomized, Single-dose, Two-way Crossover Bioequivalence Study to Compare Two Strengths (10 mg and 20 mg) of Senaparib Capsules in Healthy Chinese Subjects Following Oral Administration Under Fasting Condition 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 capsules(20mg) and Senaparib capsules(10mg)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteChina
Study dates: 21 Jun 2024to 15 Jul 2024
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 (ICF) 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 27.0 kg/m2 (inclusive); body weight ≥ 50.0 kg.
Vital signs measurement [reference range (inclusive): systolic blood pressure 90 to 140 mmHg, diastolic blood pressure 60 to 90 mmHg, pulse 50 to 100 bpm, body temperature (ear temperature) 35.8 to 37.2°C], comprehensive physical examination, other clinical laboratory tests during the screening period and auxiliary examination showed normal or abnormal results by the investigator without clinical significance.
Subjects could communicate well with the investigators and understood and abided by the requirements of this trial.

Who cannot join

(Inquiry) 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.
(Inquiry) Subjects with allergic history (including drug and food allergies, etc.) and allergy to Senaparib capsules or any component of the drug product.
(Inquiry) Subjects with history of dysphagia or any gastrointestinal disease that affected drug absorption judged by the investigator.
(Inquiry) Subjects who had received surgery within 3 months before screening, or planned to have surgery during the trial period, or those who had previous surgery that would affect drug absorption (e.g. gastrectomy).
(Inquiry) Subjects who could not tolerate venipuncture, or had a history of needlesickness and fainting at the sight of blood.
(Inquiry) Subjects who had drug abuse history within 6 months before screening.

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(Inquiry) 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 could not give up alcohol during the trial.
(Inquiry) Subjects who consumed an average of more than 5 cigarettes per day within3 months before screening, or who could not stop using any tobacco products during the trial.
(Inquiry) 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.
(Inquiry) Subjects who had participated in clinical trials of other study drugs/devices within 3 months before screening (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), or had participated in 3 or more clinical trials of drugs/devices in the past year.
(Inquiry) Subjects who donated blood including blood component or had massive blood loss (≥ 400 mL), or received blood transfusion or used blood products and blood biological products within 3 months before screening.
(Inquiry) Subjects who received live vaccines within 4 weeks before screening.
(Inquiry) Subjects who had taken any drugs [such as: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; SSRI(selective serotonin reuptake inhibitor) antidepressants, cimetidine, macrolides, nitroimidazoles, sedative hypnotics, fluoroquinolones, antihistamines, antivirals (such as saquinavir), calcium antagonists (such as diltiazem, verapamil), rifamycins (such as rifampicin)] that inhibit or induce the liver to metabolize drug within 28 days before screening. 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.
(Inquiry) Subjects who had taken prescription drugs, over-the-counter drugs, dietary supplements or Chinese herbal medicine within 14 days before screening. 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.
At screening, the corrected QT interval (corrected by Fridericia's formula, QTcF(Corrected QT interval using Fridericia's fomula) = QT/RR1/3) > 450 msec or QRS complex > 120 msec was obtained by 12-lead ECG in supine position in resting state, or the presence of other clinically significant abnormalities was judged by the investigator.
(Inquiry) Vigorous exercise could not be avoided within 48 hours before the first dose of the investigational drug and during the trial.
(Inquiry) Subjects who could not abstain from any food or beverages containing alcohol, caffeine, chocolate, or rich in xanthine within 48 hours before the first dose of the investigational drug and during the trial.
(Inquiry) Subjects who could not abstain from grapefruit or grapefruit-related citrus (e.g., pomelo) or juice within 7 days before the first dose of investigational drug and during the trial.
(Inquiry) 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.
(Inquiry) Subjects who were unwilling or unable to follow the lifestyle guidelines described in the study protocol (such as dietary restrictions and activity requirements).
Subjects judged by the investigator to be unsuitable for participation in the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Wuhan Jinyintan Hospital (Wuhan Infectious Disease Hospital)
Wuhan, Hubei

Other trials in China

About this study

Official title: An Open-label, Randomized, Single-dose, Two-way Crossover Bioequivalence Study to Compare Two Strengths (10 mg and 20 mg) of Senaparib Capsules in Healthy Chinese Subjects Following Oral Administration Under Fasting Condition

Read the detailed description

It was planned to enroll 40 subjects in this study.

Conditions: Solid Tumor
Being tested: Senaparib capsules(20mg), Senaparib capsules(10mg)

What participants receive

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

Senaparib capsules(20mg)Drug
Single oral dose of Senaparib administered under fasting condition, 1*20mg capsules in first intervention period and then 2*10mg capsules in second intervention period (after washout period: at least 5 days)
Senaparib capsules(10mg)Drug
Single oral dose of Senaparib administered under fasting condition, 2*10mg capsules in first intervention period and then 1*20mg capsules in second intervention period (after washout period: at least 5 days)

Study groups in NCT07019194
Study group	Role	What they receive
Senaparib capsules first 120mg then 210mg	Experimental	Single oral dose of Senaparib administered under fasting condition, 120mg capsules in first intervention period and then 210mg capsules in second intervention period (after washout period: at least 5 days) Receives: Drug: Senaparib capsules(20mg); Drug: Senaparib capsules(10mg)
Senaparib capsules first 210mg then 120mg	Experimental	Single oral dose of Senaparib administered under fasting condition, 210mg capsules in first intervention period and then 120mg capsules in second intervention period (after washout period: at least 5 days) Receives: Drug: Senaparib capsules(20mg); Drug: Senaparib capsules(10mg)

What is being measured

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

Cmax
Maximum concentration.
Measured: 0-48 hour
AUC0-last
area under the curve from time 0 to the last time with quantifiable concentration
Measured: 0-48 hour
AUC0-inf
if the data were available, area under the curve from time 0 to infinity
Measured: 0-48 hour

Timeline

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

21 Jun 202415 Jul 2024

First posted13 Jun 2025
Study start21 Jun 2024
Primary completion15 Jul 2024
Study completion15 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07019194
Sponsor's protocol ID: IMP4297-113
Status last verified: Jun 2025
First submitted: 23 May 2025
Last updated: 13 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomized, Single-dose, Two-way Crossover Bioequivalence Study to Compare Two Strengths (10 mg and 20 mg) of Senaparib Capsules in Healthy Chinese Subjects Following Oral Administration Under Fasting Condition
ClinicalTrials.gov ID: NCT07019194
Acronym / sponsor ID: IMP4297-113
Conditions: Solid Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Impact Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 21 Jun 2024 (actual)
Primary completion: 15 Jul 2024 (actual)
Study completion: 15 Jul 2024 (actual)
First posted: 13 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

It was planned to enroll 40 subjects in this study.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Senaparib capsules first 120mg then 210mg	Experimental	Drug: Senaparib capsules(20mg), Drug: Senaparib capsules(10mg)Single oral dose of Senaparib administered under fasting condition, 120mg capsules in first intervention period and then 210mg capsules in second intervention period (after washout period: at least 5 days)
Senaparib capsules first 210mg then 120mg	Experimental	Drug: Senaparib capsules(20mg), Drug: Senaparib capsules(10mg)Single oral dose of Senaparib administered under fasting condition, 210mg capsules in first intervention period and then 120mg capsules in second intervention period (after washout period: at least 5 days)

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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 (ICF) 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 27.0 kg/m2 (inclusive); body weight ≥ 50.0 kg.
Vital signs measurement [reference range (inclusive): systolic blood pressure 90 to 140 mmHg, diastolic blood pressure 60 to 90 mmHg, pulse 50 to 100 bpm, body temperature (ear temperature) 35.8 to 37.2°C], comprehensive physical examination, other clinical laboratory tests during the screening period and auxiliary examination showed normal or abnormal results by the investigator without clinical significance.
Subjects could communicate well with the investigators and understood and abided by the requirements of this trial.

Key exclusion criteria (21 listed)

(Inquiry) 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.
(Inquiry) Subjects with allergic history (including drug and food allergies, etc.) and allergy to Senaparib capsules or any component of the drug product.
(Inquiry) Subjects with history of dysphagia or any gastrointestinal disease that affected drug absorption judged by the investigator.
(Inquiry) Subjects who had received surgery within 3 months before screening, or planned to have surgery during the trial period, or those who had previous surgery that would affect drug absorption (e.g. gastrectomy).
(Inquiry) Subjects who could not tolerate venipuncture, or had a history of needlesickness and fainting at the sight of blood.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Senaparib capsules(20mg)Single oral dose of Senaparib administered under fasting condition, 120mg capsules in first intervention period and then 210mg capsules in second intervention period (after washout period: at least 5 days)	Drug	Senaparib capsules first 120mg then 210mg, Senaparib capsules first 210mg then 120mg
Senaparib capsules(10mg)Single oral dose of Senaparib administered under fasting condition, 210mg capsules in first intervention period and then 120mg capsules in second intervention period (after washout period: at least 5 days)	Drug	Senaparib capsules first 120mg then 210mg, Senaparib capsules first 210mg then 120mg

Primary outcome

Cmax
Time frame: 0-48 hour
Maximum concentration.
AUC0-last
Time frame: 0-48 hour
area under the curve from time 0 to the last time with quantifiable concentration
AUC0-inf
Time frame: 0-48 hour
if the data were available, area under the curve from time 0 to infinity

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
Individual participant dataSharing planned: No

Related trials for Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chaolin Huang principal investigator

Wuhan Jinyintan Hospital (Wuhan Infectious Disease Hospital)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Senaparib capsules(20mg) and Senaparib capsules(10mg) 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 5 inclusion and 21 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 13 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: 0-48 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 NCT07019194.

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 13 Jun 2025.