Food Effect Study of IDX-1197 in Healthy Subjects

NCT05202912 | Completed Phase 1

• 1 other identifier: ID-VDP-104
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Study to Evaluate the Effects of Food or Ethnicity on the Pharmacokinetics and Safety/Tolerability of IDX-1197 After Single Oral Administration in Healthy Male Korean, Chinese, and Caucasian Volunteers

Conditions

Healthy Male

Keywords

1197; IDX-1197; venadaparib

Outcome Measures

Primary Outcomes (2)

• Cmax of IDX-1197

  PK parameters will be assessed using plasma IDX-1197 concentrations measured

  through study completion, an average of 1 year

• AUClast of IDX-1197

  PK parameters will be assessed using plasma IDX-1197 concentrations measured

  through study completion, an average of 1 year

Secondary Outcomes (5)

• AUCinf of IDX-1197

  through study completion, an average of 1 year

• Tmax of IDX-1197

  through study completion, an average of 1 year

• t1/2 of IDX-1197

  through study completion, an average of 1 year

• CL/F of IDX-1197

  through study completion, an average of 1 year

• Vd/F of IDX-1197

  through study completion, an average of 1 year

Study Arms (2)

Cohort A(Food effect)

OTHER

Drug: IDX-1197(After a meal)

Cohort B(Single dose)

OTHER

Drug: IDX-1197(fasting)

Interventions

IDX-1197(After a meal) DRUG

randomized, open-label, single-dose, 2-period, 2-sequence crossover study in healthy male Korean and Caucasian volunteers

Cohort A(Food effect)

IDX-1197(fasting) DRUG

open-label, single-dose study in Chinese male volunteers

Cohort B(Single dose)

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male Korean, Chinese, or Caucasian adults at the age of ≥19 to ≤50 years old at the time of written informed consent:
• Body weight ≥55.0 kg AND body mass index (BMS) ≥18.0 kg/m2 to \<30.0 kg/m2 at screening: BMI(kg/m2) = body weight (kg) / {height (m)}2
• The subject must voluntarily decide to participate in the study after being informed of, and fully understanding, details of the study; written informed consent must be obtained prior to any of the screening procedures.
• Eligible for this study as determined by the investigator based on physical examinations, clinical laboratory tests, and interviews.

You may not qualify if:

• Evidence or history of clinically significant hepatic, renal, neurological, respiratory, endocrine, blood and tumor, cardiovascular, urinary, and psychiatric disorders.
• Evidence or history of gastrointestinal disorders (gastrointestinal ulcer, gastritis, gastrodynia, gastroesophageal reflux disease, Crohn's disease, etc.) that might affect the safety and PK of IP and/or history of gastrointestinal surgery (except for simple appendectomy and hernia repair).
• Hypersensitivity to drugs or history of any clinically significant hypersensitivity.
• Any of the following screening test results:
• Hemoglobin level \< 12.0 g/dL
• Creatinine clearance: \<60 mL/min/1.73m2 as calculated by the equation of Modification of Diet in Renal Disease
• QTc interval: \> 450 ms
• Positive serum tests (hepatitis B, hepatitis C, human immunodeficiency virus, syphilis)
• Screening systolic blood pressure \<90 mmHg or \>150 mmHg and/or diastolic blood pressure \<60 mmHg or \>100 mmHg as measured in sitting position after ≥3 minutes of rest.
• History of drug abuse or a positive urine screening test for drugs of abuse.
• Prior or expected treatment with any prescription drugs or herbal medicine within 2 weeks and/or any over the counter drugs, health functional foods, or vitamins within 1 week prior to the planned first IP dosing (individuals who are determined to be eligible at the discretion of the investigator based on other criteria will be allowed to participate in the study).
• Treatment with drug metabolizing enzyme inducers and/or suppressors such as barbitals within 1 month prior to the planned first IP dosing.
• Having participated in another clinical trial or a bioequivalence study and administered any IP within 6 months prior to the planned first IP dosing in the present study.
• Whole blood donation within 2 months and/or apheresis donation within 1 month and/or blood transfusion within 1 month prior to the planned first IP dosing.
• Continuous, excessive caffeine intake or continuous alcohol intake or unable to refrain from caffeine/alcohol consumption during hospitalization.

Sponsors & Collaborators

• Idience Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Design

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

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 24, 2022
• Study Start: January 16, 2022
• Primary Completion: July 23, 2022
• Study Completion: July 23, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-01

Locations

KR (1)