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Solid TumorPhase 1NCT04584515

IMP4297 DDI (Drug-Drug Interaction)Trial in Healthy Male Volunteers

A Phase 1 study testing IMP4297 40 mg and IMP4297 100 mg 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, Open-label, Fixed-Sequence Study to Evaluate the Effect of Multiple-dose Itraconazole or Rifampicin Capsules on the Single-dose PK Profiles of IMP4297 Capsules in Healthy Subjects 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 40 mg and IMP4297 100 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
2 Nov 2020to 27 May 2021
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 understand the purpose, nature, methods and possible adverse reactions of the trial, voluntarily participate in the trial, and sign an informed consent form before any trial procedure, and promise to participate in all procedure of the trial.
  • Healthy Chinese male subjects aged 18 to 55 (inclusive) at the time of signing informed consent form.
  • Body mass index (BMI) ranges from 19.0 to 26.0 kg/m2 (inclusive); body weight ≥ 50.0 kg.
  • Subjects can communicate well with the investigators and understand and abide by the requirements of this trial.

Who cannot join

  • Subjects with past and present diseases with clinical abnormality in the opinion of the investigator, 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 affects drug absorption judged by the investigator.
  • Subjects who have received surgery within 3 months before screening, or plan to have surgery during the trial period, or those who had surgery that will affects drug absorption (e.g. gastrectomy).
  • Subjects who cannot tolerate venipuncture, or have a history of needlesickness and fainting at the sight of blood.
  • Subject with lactose intolerability (who having had milk diarrhea).
Show all 27Show fewer
  • Subjects who have drug abuse history within 6 months before screening, or have a positive urine drug screening (screening or baseline period) result.
  • Subjects who have used narcotics within 3 months before screening.
  • Subjects who consumed an average of 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 have participated in clinical trials of other study drugs/devices within 3 months before the first dose of the investigational drug, or have participated in 3 or more clinical trials of drugs/devices in the past year; if other study drugs have a longer half-life, the time interval will be longer and is required to be 5 half-lives of the drug.
  • Subjects who donated blood including blood component or have massive blood loss (2,200 mL), or received blood transfusion or used blood products within 3 months before screening.
  • Subjects who received vaccination within 4 weeks before screening.
  • Subjects who have taken any drugs [such as: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; SSRI antidepressants, cimetidine, macrolides, nitroimidazoles, sedative hypnotics, fluoroquinolones, antihistamines, antivirals (such as saquinavir), calcium antagonists (such as diltiazem, verapamil), rifamycins (such as rifampin)] that inhibit or induce the liver to metabolize drug within 28 days before the first dose of the investigational drug. If the past drug used has a longer half-life, the time interval will be longer and is required to be 5 half-lives of the drug, eg, Phenobarbital requires a 5-week washout period.
  • Subjects who have 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 has a longer half-life, the time interval will be longer and is required to be 5 half-lives of the drug.
  • Any test result of hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody is positive.
  • At screening, vital signs (blood pressure, pulse and body temperature) examination, comprehensive physical examination and laboratory tests (hematology, blood biochemistry, urinalysis) indicate abnormal results with clinical significance according to the investigator. The reference normal range of vital signs (including the cut-off value) is as follows: Sitting systolic blood pressure is 90 to 139 mmHg, diastolic blood pressure is 60 to 89 mmHg, pulse is 50 to 100 bmp, body temperature (frontal temperature) is 36.0 to 37.0°C. The specific situation is comprehensively determined by the investigator.
  • At screening after a quiet rest for at least 10 min, the corrected QT interval (corrected by Fridericia's formula, QTcF = QT/RR1/3) > 450 msec or QRS complex > 120 msec was obtained by 12-lead ECG in supine position. If QTcF is more than 450 msec or QRS is more than 120 msec, 12-lead ECG measurement should be repeated twice, and the average value of QTcF or QRS measured three times is judged by the investigator as abnormality with clinical significance.
  • Subjects who are allergic to IMP4297, Itraconazole, Rifampicin, or to any ingredients of these preparations.
  • Vigorous exercise cannot be avoided within 48 hours before the first dose of the investigational drug and during the trial.
  • Subjects who consumed any food or beverages containing alcohol, caffeine, chocolate, or rich in xanthine within 48 hours before the first dose of the investigational drug; or those who cannot abstain from these products during the trial.
  • Subjects who cannot abstain from grapefruit or grapefruit-related citrus (eg, pomelo) or juice within 7 days before the first dose of investigational drug and during the trial;
  • Subjects or its partners who have birth plan, or are unwilling to adopt effective contraception methods (Annex 2), or have sperm donation plan throughout the trial and within 180 days after the last dose of the investigational drug.
  • Subjects who are unwilling or unable to follow the lifestyle guidelines described in the study protocol (such as dietary restrictions and activity requirements).
  • Subjects who have other acute or chronic medical or psychiatric diseases, which may increase the risks of participating in this trial, or may interfere with the interpretation of the trial results, will be judged unsuitable to participate in this trial by the investigator.
  • Subjects judged by the investigator to be unsuitable for participation in the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Impact Therapeutics, Inc.

    Shanghai, 201210

Other trials in China

About this study

Official title: A Phase I, Open-label, Fixed-Sequence Study to Evaluate the Effect of Multiple-dose Itraconazole or Rifampicin Capsules on the Single-dose PK (Pharmacokinetics) Profiles of IMP4297 Capsules in Healthy Subjects

A Phase I, Open-label, Fixed-Sequence Study to Evaluate the Effect of Multiple-dose Itraconazole or Rifampicin Capsules on the Single-dose PK Profiles of IMP4297 Capsules in Healthy Subjects

Read the detailed description

Study design A Phase I, single-center, open-label, fixed-sequence study is designed to evaluate the effect of multiple-dose Itraconazole or Rifampicin Capsules on the single-dose PK profiles of IMP4297 Capsules in healthy Chinese subjects.

32 subjects are planned to be enrolled (at least 12 subjects complete the study on one side).

Two parallel groups will be planned in this study with 16 subjects enrolled in each group. Two cycles are set for each group. The first group will be given IMP4297 and Itraconazole in a fixed sequence (two dosing regimens); The second group will receive IMP4297 and Rifampicin in a fixed sequence (two dosing regimens).

Conditions
Solid Tumor
Being tested
IMP4297 40 mg, IMP4297 100 mg

What participants receive

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

  • IMP4297 40 mgDrug

    Also called Itraconazole

    IMP4297 40 mg: IMP4297 alone, Itraconazole + IMP4297

  • IMP4297 100 mgDrug

    Also called Rifampin

    IMP4297 100 mg: IMP4297 alone, Rifampin + IMP4297

Study groups in NCT04584515
Study groupRoleWhat they receive
IMP4297 40 mgExperimentalSequential treatments of IMP4297 alone, followed by Itraconazole + IMP4297, with a washout period in between.
Receives: Drug: IMP4297 40 mg
IMP4297 100 mgExperimentalSequential treatments of IMP4297 alone, followed by Rifampin + IMP4297, with a washout period in between.
Receives: Drug: IMP4297 100 mg

What is being measured

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

  1. Cmax (Maximum concentration)

    peak concentration

    Measured: 3 months

  2. AUC0-last (Area under the curve from time 0 to the last time with quantifiable concentration)

    AUC0-last area under the curve from time zero to the time with the last quantifiable concentration

    Measured: 3 months

  3. AUC0-inf (Area under the curve from time 0 to infinity)

    area under the curve from time zero to infinity

    Measured: 3 months

Secondary outcomes (5)

  1. Number of Participants with Adverse Events That Are Related to Treatment

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

    Measured: 3 months

  2. Tmax (Time to reach maximum concentration)

    time to reach Cmax

    Measured: 3 months

  3. t½ (Elimination half-life)

    elimination half-life

    Measured: 3 months

  4. CL/F (Apparent clearance)

    apparent clearance

    Measured: 3 months

  5. Vz/F (apparent volume of distribution )

    apparent volume of distribution

    Measured: 3 months

Timeline

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

  1. First posted14 Oct 2020
  2. Study start2 Nov 2020
  3. Primary completion8 Mar 2021
  4. Study completion27 May 2021

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04584515
Sponsor's protocol ID
IMP4297-104
Status last verified
Aug 2021
First submitted
29 Sep 2020
Last updated
24 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Hu X, Hsieh CY, Zhang Y, Liu W, Xu S, Cai SX, Liu L, Zhang M, Shi H, Zhang H, Liu P, Li X, Xu P. Effect of a strong CYP3A4 inhibitor and inducer on the pharmacokinetics of senaparib (IMP4297) in healthy volunteers: A drug-drug interaction study. Br J Clin Pharmacol. 2023 Jun;89(6):1767-1779. doi: 10.1111/bcp.15624. Epub 2023 Jan 3.

    PubMed 36458825

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMP4297 40 mg and IMP4297 100 mg 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 4 inclusion and 27 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 24 Aug 2021. 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 (Maximum concentration) (time frame: 3 months). 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 NCT04584515, 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 24 Aug 2021.

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