An BE Study to Compare 10mg & 20mg of IMP4297 Capsules in Healthy Chinese Subjects Under Fasting Condition

NCT05390944 | Completed Phase 1

• 1 other identifier: IMP4297-110-1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

An open-label, randomized, single-dose, two-way crossover bioequivalence study to compare two strengths (10 mg and 20 mg) of IMP4297 capsules in healthy Chinese subjects under fasting condition.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Cmax

  Maximum concentration. In each cycle, blood PK samples are collected at 0 hour (within 1 hour pre-dose) and 0.25 hour, 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 10 hour, 12 hour, 24 hour, 48 hour and 72 hour post-dose for analysis of plasma IMP4297 concentrations, with quiet rest for 5 minutes after blood collection.

  0-72 hours

• AUC0-last

  area under the drug concentration-time curve from time 0 to the last time with quantifiable concentration. In each cycle, blood PK samples are collected at 0 hour (within 1 h pre-dose) and 0.25 hour, 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 10 hour, 12 hour, 24 hour, 48 hour and 72 hour post-dose for analysis of plasma IMP4297 concentrations, with quiet rest for 5 minutes after blood collection.

  0-72 hours

• AUC0-inf

  area under the curve from time 0 to infinity. In each cycle, blood PK samples are collected at 0 hour (within 1 hour pre-dose) and 0.25 hour, 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 10 hour, 12 hour, 24 hour, 48 hour and 72 hour post-dose for analysis of plasma IMP4297 concentrations, with quiet rest for 5 minutes after blood collection.

  0-72 hours

Study Arms (2)

IMP4297 first 5*20mg then 10*10mg

EXPERIMENTAL

Single oral dose of IMP4297 administered under fasting conditions 5\*20 mg capsules in first intervention period and 10\*10 mg capsules in second intervention period (after washout period: at least 7 days)

Drug: IMP4297(20mg); Drug: IMP4297(10mg)

IMP4297 first 10*10mg then 5*20mg

EXPERIMENTAL

Single oral dose of IMP4297 administered under fasting conditions 10\*10 mg capsules in first intervention period and 5\*20 mg capsules in second intervention period (after washout period: at least 7 days)

Drug: IMP4297(20mg); Drug: IMP4297(10mg)

Interventions

IMP4297(20mg) DRUG

Single oral dose of IMP4297 administered under fasting conditions 5\*20 mg capsules in first intervention period and 10\*10 mg capsules in second intervention period (after washout period: at least 7 days)

IMP4297 first 10*10mg then 5*20mg; IMP4297 first 5*20mg then 10*10mg

IMP4297(10mg) DRUG

Single oral dose of IMP4297 administered under fasting conditions 10\*10 mg capsules in first intervention period and 5\*20 mg capsules in second intervention period (after washout period: at least 7 days)

IMP4297 first 10*10mg then 5*20mg; IMP4297 first 5*20mg then 10*10mg

Eligibility Criteria

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

You may qualify if:

• The subject fully understands the objective, nature, method of the trial and possible adverse reactions, voluntarily acts as a subject, signs the informed consent form before any study procedure, and ensures that any procedure is performed by himself/herself.
• Healthy Chinese male subjects aged 18 to 55 years (inclusive) at Screening.
• Body mass index (BMI) between 19.0 and 26.0 kg/m2 (inclusive); body weight ≥50.0 kg.
• Subject is able to communicate well with the Investigator and understands and adheres to the requirements of the study.

You may not qualify if:

• History of allergic diseases (including drug allergies and food allergies, etc.), and allergy to IMP4297 capsules or any component of the product.
• History of dysphagia or any gastrointestinal disease affecting drug absorption (as judged by the investigator).
• Subjects having experienced surgery within 3 months prior to screening, or having a surgery planned during the study period, and having received any surgery that may affect drug absorption (e.g., gastrectomy).
• Subjects who cannot tolerate venipuncture and who ever fainted during injection or at sight of blood.
• Lactose intolerance (those who had diarrhea after drinking milk).
• History of drug abuse within 6 months prior to screening, or a positive result on the urine drug screen (screening or baseline).
• Subjects who drink more than 14 units of alcohol (1 unit of alcohol = 360 mL of beer, 150 mL of wine, or 45 mL of liquor) per week within 3 months prior to screening, or have a positive breath alcohol test (screening or baseline), or cannot abstain from alcohol during the trial.
• Subjects who smoke more than 5 cigarettes per day on average within 3 months prior to screening, or cannot stop using any tobacco products during the trial.
• Subjects who consumed excessive amount of tea, coffee, and/or caffeine-rich beverages (more than 8 cups, 1 cup = 250 mL) per day on average during the 3 months prior to screening.
• Subjects who have participated in the clinical trial of other study drug/device within 3 months before the first administration of the study drug, or have participated in 3 or more clinical trials of drugs/devices in the past year; if the half-life of other study drugs is longer, the longer time interval is required, that is, 5 half-lives of the drug.
• Blood donation with blood components or significant blood loss (≥ 200 mL) within 3 months prior to screening; blood transfusion or use of blood products and blood biological products within 3 months prior to screening.
• Subjects who have received live vaccination within 4 weeks prior to screening.
• Used any drugs \[e.g. barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; SSRI antidepressants, cimetidine, macrolides, nitroimidazoles, sedative hypnotics, fluoroquinolones, antihistamines, antiviral drugs (such as saquinavir, etc.), calcium antagonists (such as diltiazem, verapamil, etc.), rifamycins (such as rifampicin, etc.)\] that inhibit or induce hepatic metabolism of drugs within 28 days prior to taking study drug. If the half-life of a prior medication is longer, the required time interval will also be prolonged, that is, 5 half-lives of the drug, e.g. a 5-week washout period for phenobarbital.
• Used prescription drugs, over-the-counter drugs, dietary supplements, or Chinese herbal medicines within 14 days prior to the first dose of study drug. If the half-life of a prior medication is longer, the required time interval will also be prolonged, that is, 5 half-lives of the drug. For over-the-counter medications that are not considered to affect the overall outcome of the study, limited use is permitted on a case-by-case basis after approval by the Sponsor and the Investigator.
• Positive for any of the hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, anti-human immunodeficiency virus antibody, or treponema pallidum antibody tests.

Sponsors & Collaborators

• Impact Therapeutics, Inc.: lead

Study Sites (1)

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221000, China

Location

MeSH Terms

Interventions

senaparib

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: May 20, 2022
• First Posted: May 25, 2022
• Study Start: June 8, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)