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Solid TumorPhase 1NCT04057729

IMP4297 Food Effect Trial in Healthy Volunteers

A Phase 1 study testing IMP4297 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

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 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?
IMP4297
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteChina
Study dates
22 Jul 2019to 27 Sep 2019
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

  • 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.

Who cannot join

  • 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).
Show all 26Show fewer
  • 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.
  • Have taken any drugs that inhibit or induce hepatic metabolism of the drug within 28 days prior to taking the investigational drug [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 rifampin, etc.)].
  • Have taken prescription or over-the-counter medicine, dietary supplement or herbal remedy within 14 days prior to the first dose of investigational drug. If the half-life of the concomitant drug is longer, the time interval required will be longer, which is suggested as 5 half-lives of the investigational drug.
  • Any abnormal result in laboratory tests and other examination, which is judged as clinical significance by the investigator.
  • Have positive result in hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody screening.
  • Have clinically significant abnormality in blood pressure, pulse and body temperature, reference to normal range (including boundary value): blood pressure 90-139/60-89 mmHg; pulse 60-100 bpm; body temperature (ear temperature) 35.4-37.7℃, the specific conditions would be comprehensively determined by the investigator.
  • At screening, corrected QT interval (corrected by Fridericia's formula, QTcF = QT/RR1/3) > 450 msec or QRS complex > 120 msec in 12-lead electrocardiogram (ECG) resting on supine. If QTc exceeds 450 msec or QRS exceeds 120 msec, 2 additional ECG measurements should be repeated, and the subject's eligibility will be determined by using the average value of the 3 QTc or QRS measurements.
  • Unwilling or unable to follow the lifestyle guideline described in the study protocol (e.g. dietary restrictions, activity and contraceptive requirements).
  • Have other acute or chronic medical or psychiatric disease that, in the judgment of the investigator, would make the subject unsuitable or increase the risk associated with participating in this study, or would interfere with interpretation of the study results.
  • Have consumed chocolate, any caffeine-containing, xanthine-containing foods or beverages, and other special diets affecting the absorption, distribution, metabolism, and excretion of the drug during the admission period from screening to Day -2.
  • Inability to keep abstinence from grapefruit or grapefruit-related citrus (e.g. pomelo) fruits or juices within 7 days prior to the first dose of study drug and for the duration of the study.
  • Other subjects, judged by investigators, to be unsuitable for participation in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Public Health Clinical Center

    Shanghai

Other trials in China

About this study

Official title: An Open-label, Randomized, Single-dose, Two-way Crossover Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of IMP4297 Capsules in Healthy Subjects

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

Read the detailed description

This food-effect study plans to enroll 16 (at least 12 to complete the study) subjects. Subjects will be randomly assigned to 1 of 2 dosing sequences (fasted or standard high-fat breakfast) at a 1:1 ratio generated from a computer. Each dosing sequence will consist of 2 cycles, with 1 dose in each cycle of the study and a washout period of at least 7 days between each dose. Study drug will be administered to subjects in the morning of each administration day of each cycle. PK, ECG, vital signs, physical examinations and laboratory tests will be performed as specified in the protocol. Tolerability and safety of the treatment will be evaluated by monitoring adverse events.

Conditions
Solid Tumor
Being tested
IMP4297

What participants receive

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

  • IMP4297Drug

    10mg/capsule.

Study groups in NCT04057729
Study groupRoleWhat they receive
Arm 1 （IMP4297 100mg, Fasted-Fed）ExperimentalPeriod 1: Fasted control → Period 2: Fed control
Receives: Drug: IMP4297
Arm 2（IMP4297 100mg, Fed- Fasted）ExperimentalPeriod 1: Fed control → Period 2: Fasted control
Receives: Drug: IMP4297

What is being measured

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

  1. Cmax

    Peak Plasma Concentration

    Measured: 2-month

  2. Tmax

    Time To Reach Maximum Concentration

    Measured: 2-month

  3. AUC

    Area Under The Curve

    Measured: 2-month

  4. t1/2

    Elimination Half-Life

    Measured: 2-month

Secondary outcomes (1)

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

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

    Measured: 2-month

Timeline

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

  1. First posted15 Aug 2019
  2. Study start22 Jul 2019
  3. Primary completion27 Sep 2019
  4. Study completion27 Sep 2019

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
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04057729
Sponsor's protocol ID
IMP4297-103
Status last verified
Mar 2020
First submitted
29 Jul 2019
Last updated
30 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 36239914

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMP4297 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 6 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 30 Mar 2020. 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: 2-month). The study lists 4 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 NCT04057729, which also lists 1 linked publication.

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 30 Mar 2020.

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