A Clinical Trial to Evaluate a High-Fat Meal and Omeprazole Enteric-coated Tablets on ASBK021

NCT06322706 | Completed Phase 1

• 1 other identifier: ABSK021-105
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Part A: a single-center, randomized, open-label, three-cycle study to evaluate the pharmacokinetic (PK) profile of different doses of ABSK021 Capsules and the effect of a high-fat meal on the pharmacokinetic profile of ABSK021 Capsules in healthy subjects Part B: a single-center, open-label, fixed-sequence study to evaluate the effect of multiple oral doses of Omeprazole Enteric-coated Tablets on the PK profile of ABSK021 Capsules in healthy subjects

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (4)

• Cmax

  PK samples were collected according to the protocol requirements

  predose up to 240 hours post-dose

• tmax

  PK samples were collected according to the protocol requirements

  predose up to 240 hours post-dose

• AUC0-∞

  PK samples were collected according to the protocol requirements

  predose up to 240 hours post-dose

• AUClast

  PK samples were collected according to the protocol requirements

  predose up to 240 hours post-dose

Secondary Outcomes (8)

• AE

  up to 3 months

• SAE

  up to 3 months

• blood pressure

  up to 1 months

• respiratory rate

  up to 1 months

• ECG QT Interval

  predose up to 240 hours post-dose

Study Arms (2)

ABSK021

EXPERIMENTAL

Drug: ABSK021

ABSK021and Omeprazole

EXPERIMENTAL

Drug: ABSK021; Drug: Omeprazole

Interventions

ABSK021 DRUG

ABSK021 oral

ABSK021; ABSK021and Omeprazole

Omeprazole DRUG

Omeprazole oral

ABSK021and Omeprazole

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects aged 18 to 45 years (inclusive) at Screening;
• Weight ≥ 50.0 kg (male) or ≥ 45.0 kg (female), with a body mass index (BMI) between 19.0 and 28.0 (inclusive), BMI = weight (kg)/height (m)2;
• Normal or abnormal but not clinically significant results in medical history, physical examination, clinical laboratory tests and other relevant examinations as assessed by the investigator at Screening;
• Male or female subjects of childbearing potential must agree to use effective methods of contraception during the study and within 6 months after the last dose of investigational product (see section 5.4 for details), and male subjects should not donate sperm during such period; female subjects should not donate ovum during such period and should not be pregnant or lactating. Pregnancy period is defined as the period from the date of conception until termination of pregnancy, and will be determined by laboratory test of human chorionic gonadotropin (hCG) within 7 days prior to initiation of the study;
• Willing to participate in this study, understand the study procedures and sign the informed consent form prior to screening; willing to comply with the study procedures.

You may not qualify if:

• Past or current medical history of chronic or severe conditions in cardiovascular, respiratory, blood, liver, kidney, gastrointestinal, endocrine or nervous systems;
• Known or persistent mental disorders that may preclude the subject from participation in the study, as determined by the investigator;
• Past history of gastric or intestinal surgery, or other operations (except for appendectomy) affecting the drug absorption;
• Dysphagia and inability to take the investigational product orally;
• Intolerant to venipuncture, difficult to collect blood samples, and fear of needle sickness and blood;
• Known allergy to two or more kinds of foods and drugs; or allergic to ABSK021 or its excipients (lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, gelatin), allergic to omeprazole; and prone to allergic reactions such as rash and urticaria;
• History of bacterial, fungal, parasitic, viral (excluding nasopharyngitis), mycobacterial infection, and COVID19 infection within 30 days prior to screening; or abnormal chest X-ray finding, assessed as clinically significant (by the investigator);
• Symptoms of fatigue and pyrexia within 2 weeks prior to screening;
• Abnormal laboratory tests: Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \> 1 × ULN; Creatinine \> 1 × ULN; Total Bilirubin (TBIL) \> 1.5 × ULN; Creatine Kinase (CK) \> 1.5 × ULN; amylase \> 1 × ULN; Lactate Dehydrogenase (LDH) \> 1.5 × ULN; Serum Potassium \< Lower Limit of Normal (LLN); and hemoglobin \< LLN;
• Positive result for either of the following tests: serum Hepatitis B Surface Antigen (HBsAg), Hepatitis B e Antigen (HBeAg), Hepatitis B e Antibody (HBeAb), Hepatitis B Core Antibody (HBcAb), Hepatitis C Virus (HCV) antibody, Human Immunodeficiency Virus (HIV) antibody, and treponema pallidum antibody;
• Pregnant or lactating women, or those with a positive pregnancy test;
• Participated in any clinical studies of drugs as a study subject and received the study drug within 3 months prior to screening;
• Previously participated in any other study related to ABSK021 and received ABSK021;
• Used strong inhibitors or inducers of CYP3A4 (including grapefruit juice, grapefruit hybrids, punica granatum, carambola, citrus maxima, and Seville oranges \[including its juices or other processed products\]; see Appendix 12.2Contraindicated Medications and Products for Concomitant Use with ABSK021 or Omeprazole for the detailed list) within 14 days prior to screening and at Screening;
• Used strong inhibitors or inducers of CYP2C19 (including Fluoxetine, Fluvoxamine, Ticlopidine, Rifampin, etc., see Appendix 12.2 Contraindicated Medications and Products for Concomitant Use with ABSK021 or Omeprazole for the detailed list) within 14 days prior to screening and at Screening;

Sponsors & Collaborators

• Abbisko Therapeutics Co, Ltd: lead

Study Sites (1)

Wuxi People's Hospital

Wuxi, JiangShu, 214023, China

Location

MeSH Terms

Interventions

Omeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kai Huang

  No. 299, Qingyang Road, Wuxi City, Jiangsu Province

  PRINCIPAL INVESTIGATOR

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: February 29, 2024
• First Posted: March 21, 2024
• Study Start: March 22, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 18, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)