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

NCT04584515 | Completed Phase 1

• 1 other identifier: IMP4297-104
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Cmax (Maximum concentration)

  peak concentration

  3 months

• 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

  3 months

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

  area under the curve from time zero to infinity

  3 months

Secondary Outcomes (5)

• Number of Participants with Adverse Events That Are Related to Treatment

  3 months

• Tmax (Time to reach maximum concentration)

  3 months

• t½ (Elimination half-life)

  3 months

• CL/F (Apparent clearance)

  3 months

• Vz/F (apparent volume of distribution )

  3 months

Study Arms (2)

IMP4297 40 mg

EXPERIMENTAL

Sequential treatments of IMP4297 alone, followed by Itraconazole + IMP4297, with a washout period in between.

Drug: IMP4297 40 mg

IMP4297 100 mg

EXPERIMENTAL

Sequential treatments of IMP4297 alone, followed by Rifampin + IMP4297, with a washout period in between.

Drug: IMP4297 100 mg

Interventions

IMP4297 40 mg DRUG

IMP4297 40 mg: IMP4297 alone, Itraconazole + IMP4297

Also known as: Itraconazole

IMP4297 40 mg

IMP4297 100 mg DRUG

IMP4297 100 mg: IMP4297 alone, Rifampin + IMP4297

Also known as: Rifampin

IMP4297 100 mg

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Impact Therapeutics, Inc.: lead

Study Sites (1)

Impact Therapeutics, Inc.

Shanghai, 201210, China

Location

Related Publications (1)

• 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.

  PMID: 36458825 DERIVED

MeSH Terms

Interventions

senaparib; Itraconazole; Rifampin

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Pingsheng Xu

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 14, 2020
• Study Start: November 2, 2020
• Primary Completion: March 8, 2021
• Study Completion: May 27, 2021
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

CN (1)