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

NCT07030439 | Completed Phase 1

• 1 other identifier: IMP4297-108
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Cmax

  Maximum concentration

  0-72 hour

• AUC0-last

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

  0-72 hour

• AUC0-inf

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

  0-72 hour

Study Arms (2)

Senaparib capsules first new manufacturing site then original manufacturing site

EXPERIMENTAL

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)

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 site

EXPERIMENTAL

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)

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.

Interventions

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 capsules first new manufacturing site then original manufacturing site; Senaparib capsules first original manufacturing site then new manufacturing site

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)

Senaparib capsules first new manufacturing site then original manufacturing site; Senaparib capsules first original manufacturing site then new manufacturing site

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Impact Therapeutics, Inc.: lead

Study Sites (1)

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Location

MeSH Terms

Interventions

senaparib; Long-Term Synaptic Depression

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Chuanling Li

  Xuzhou Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: July 18, 2021
• Primary Completion: October 12, 2021
• Study Completion: October 12, 2021
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)