IMP4297 Food Effect Trial in Healthy Volunteers

NCT04057729 | Completed Phase 1

• 1 other identifier: IMP4297-103
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

A phase I, single-site, open-label, randomized, single-dose, two-way crossover study to evaluate the effect of food on the pharmacokinetic characteristics of IMP4297 capsules in China

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (4)

• Cmax

  Peak Plasma Concentration

  2-month

• Tmax

  Time To Reach Maximum Concentration

  2-month

• AUC

  Area Under The Curve

  2-month

• t1/2

  Elimination Half-Life

  2-month

Secondary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

  2-month

Study Arms (2)

Arm 1 （IMP4297 100mg, Fasted-Fed）

EXPERIMENTAL

Period 1: Fasted control → Period 2: Fed control

Drug: IMP4297

Arm 2（IMP4297 100mg, Fed- Fasted）

EXPERIMENTAL

Period 1: Fed control → Period 2: Fasted control

Drug: IMP4297

Interventions

IMP4297 DRUG

10mg/capsule.

Arm 1 （IMP4297 100mg, Fasted-Fed）; Arm 2（IMP4297 100mg, Fed- Fasted）

Eligibility Criteria

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

You may qualify if:

• Must fully understand the purpose, nature, methods of the trial and possible adverse reactions and volunteer as a subject. Subjects have to sign informed consent themselves prior to any study-related procedures and ensure that any procedure would involve themselves in the study.
• Chinese male subjects aged 18 to 55 years (inclusive) at screening.
• Have body mass index (BMI) between 19.0 and 26.0 kg/m2 (inclusive), and body weight≥50.0 kg.
• Detailed medical history, vital signs (blood pressure, pulse and body temperature), comprehensive physical examination, laboratory tests (blood routine, blood biochemistry and urine routine), 12-lead electrocardiogram (ECG) and other test results show no abnormality or without clinical significance if abnormal.
• Have no plan of giving birth and be willing to use effective contraception; and have no plan to donate sperm during the study and 90 days after the last dose of the investigational drug. Non-drug contraception should be used during the trial voluntarily.
• Be able to communicate well with the investigator, understand and comply with the requirements of the study.

You may not qualify if:

• Have clinical abnormalities to be excluded, including but not limited to disorders of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bone and other systemic diseases.
• Have a history of allergic disease (including drug allergies, allergic reactions to two or more foods).
• Have a history of dysphagia or any gastrointestinal disorder affecting drug absorption.
• Have had surgery within 3 months prior to screening or have scheduled surgery during the study, and have had surgery which may affect the absorption, distribution, metabolism and excretion of drugs.
• Inability to tolerate venipuncture, have fear of needles and have a history of hemophobia.
• Have lactose intolerance (who have had diarrhea after drinking milk).
• History of drug abuse within 6 months prior to screening or a positive result on urine drug screen (baseline period).
• History of using narcotic drugs within 3 months prior to screening.
• Who intake more than 14 units of alcohol per week within 3 months prior to screening (1 unit of alcohol= 360 mL of beer, 150 mL of wine or 45 mL of liquor), or have positive result in alcohol breath test (baseline period), or patients who cannot abstain from alcohol during the trial.
• Who smoke more than 5 cigarettes per day within 3 months prior to screening or have positive results in urine nicotine screening test (screening period or baseline period) or unable to stop using any tobacco products during the trial.
• Excessive consumption of tea, coffee and/or caffeine-rich beverages (more than 8 cups per day, 1 cup = 250 mL) within 3 months prior to screening.
• Have participated in another investigational drug trial within 3 months or in 3 or more clinical trials within the last year before the first dose of investigational drug; If the half-life of other investigational drugs is longer, the time interval required will be longer, suggesting 5 half-lives of the investigational drug.
• Blood donation including blood components or massive blood loss (≥ 200 mL) within 3 months prior to screening; patients who had blood transfusion or have used blood products.
• Have plan of giving birth or sperm donation within 90 days.
• Have received vaccine within 4 weeks prior to screening.

Sponsors & Collaborators

• Impact Therapeutics, Inc.: lead

Study Sites (1)

Shanghai Public Health Clinical Center

Shanghai, China

Location

Related Publications (1)

• Meng X, Lin X, Jiang R, Lu Y, Zeng L, Cao M, Zhang J. Effect of Food on the Pharmacokinetics of Senaparib (IMP4297) in Healthy Chinese Subjects. Clin Drug Investig. 2022 Nov;42(11):1009-1016. doi: 10.1007/s40261-022-01198-8. Epub 2022 Oct 14.

  PMID: 36239914 DERIVED

MeSH Terms

Interventions

senaparib

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: July 29, 2019
• First Posted: August 15, 2019
• Study Start: July 22, 2019
• Primary Completion: September 27, 2019
• Study Completion: September 27, 2019
• Last Updated: March 30, 2020

Record last verified: 2020-03

Locations

CN (1)