Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06322706
Other study ID # ABSK021-105
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date March 28, 2024
Est. completion date December 31, 2025

Study information

Verified date February 2024
Source Abbisko Therapeutics Co, Ltd
Contact Yuan Lu
Phone 13700000000
Email clinical@abbisko.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

Part A: in this part, 18 healthy subjects are planned to be enrolled and will be randomized to either Study Sequence A (Sequence A) or Study Sequence B (Sequence B) (with 9 subjects in each sequence) to receive single oral dose of ABSK021 separately for a total of 3 doses, separated by 10 days. Part B: in this part, 18 healthy subjects are planned to be enrolled to receive single oral dose of ABSK021 in a fixed sequence separately for a total of 2 doses. Subjects will receive a single dose of 50 mg ABSK021 Capsules on the morning of Cycle 1 Day 1 (C1D1) under fasting conditions; and 40 mg Omeprazole once daily from Days 1 to 5 of Cycle 2 (C2D1 to C2D5); with the other single oral dose of 50 mg ABSK021 received 2 h after the dose of Omeprazole under fasting conditions on C2D5


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 36
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: 1. Healthy subjects aged 18 to 45 years (inclusive) at Screening; 2. 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; 3. 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; 4. 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; 5. 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. Exclusion Criteria: 1. Past or current medical history of chronic or severe conditions in cardiovascular, respiratory, blood, liver, kidney, gastrointestinal, endocrine or nervous systems; 2. Known or persistent mental disorders that may preclude the subject from participation in the study, as determined by the investigator; 3. Past history of gastric or intestinal surgery, or other operations (except for appendectomy) affecting the drug absorption; 4. Dysphagia and inability to take the investigational product orally; 5. Intolerant to venipuncture, difficult to collect blood samples, and fear of needle sickness and blood; 6. 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; 7. 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); 8. Symptoms of fatigue and pyrexia within 2 weeks prior to screening; 9. 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; 10. 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; 11. Pregnant or lactating women, or those with a positive pregnancy test; 12. Participated in any clinical studies of drugs as a study subject and received the study drug within 3 months prior to screening; 13. Previously participated in any other study related to ABSK021 and received ABSK021; 14. 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; 15. 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; 16. Have special diet requirements and cannot accept to take a unified dietary; specific dietary requirements: (i) the subjects can only eat the food provided by the study site during hospitalization, (ii) the subjects should avoid using strong inhibitors or inducers of CYP3A4 during the study, and (iii) the subjects should avoid using other strong inhibitors or inducers of CYP2C19 during the study (see Appendix 12.2 Contraindicated Medications and Products for Concomitant Use with ABSK021 or Omeprazole for the detailed list); 17. Consumption of more than 14 units of alcohol per week (1 unit of alcohol = about 360 mL of beer or 45 mL of spirits containing 40% alcohol or 150 mL of wine) within 3 months prior to signing the informed consent form, or a positive result for alcohol breath test on the day pre-dose (breath alcohol content > 0.0 mg/100 mL), or unable to abstain from alcohol during the study; 18. Consumption of more than 5 cigarettes per day within 3 months prior to signing the informed consent form, or unable to abstain from tobacco products during the study; 19. Positive for nicotine test; 20. Previous chronic consumption of excessive amount of tea, coffee, or caffeinated beverages (excessive intake is defined as taking more than 6 units of caffeine per day, 1 unit of caffeine equivalent to 177 mL of coffee, 355 mL of tea, 355 mL of cola, or 85 g of chocolate) or unable to abstain from caffeinated beverages during the study; 21. Known history of drug abuse or positive for drug abuse screening test (morphine, methamphetamine, ketamine, methylene dioxyamphetamine, and tetrahydrocannabinol acid); 22. Used over the counter or prescription drugs, including herbal medicine, health products, vitamins, and dietary supplements, within 14 days prior to screening, or plan to use such drugs during the study; 23. Donated or lost > 400 mL of blood within 3 months prior to screening; received blood transfusions or used blood products within 2 months prior to screening; 24. Received vaccine (including COVID19 vaccine) within 2 months prior to screening, or plan to get vaccinated during the study; 25. Significant abnormalities in vital signs, including: ear temperature > 37.7 °C; pulse rate > 100 beats/min or < 50 beats/min; systolic blood pressure = 140 mmHg or < 90 mmHg, diastolic blood pressure = 90 mmHg or < 50 mmHg; 26. Heart rate-corrected QT interval prolongation, QTcF > 450 ms (> 470 ms for females) (Note: QTc interval corrected using the Fridericia formula), or family history of long QT syndrome, or other clinically significant ECG abnormalities at Screening; 27. Plan to donate sperm or ovum within 6 months after administration of the investigational product; 28. Subjects involving in the design or conduct of this study and their immediate family members (e.g., employees of Abbisko Therapeutics Co., Ltd., employees of the CRO, and employees of the study site); 29. Subjects who, in the opinion of the investigator, are not suitable for enrollment or may not be able to complete the study for other reasons.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ABSK021
ABSK021 oral
Omeprazole
Omeprazole oral

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Abbisko Therapeutics Co, Ltd

Outcome

Type Measure Description Time frame Safety issue
Primary Cmax PK samples were collected according to the protocol requirements predose up to 240 hours post-dose
Primary tmax PK samples were collected according to the protocol requirements predose up to 240 hours post-dose
Primary AUC0-8 PK samples were collected according to the protocol requirements predose up to 240 hours post-dose
Primary AUClast PK samples were collected according to the protocol requirements predose up to 240 hours post-dose
Secondary AE The relationship of each adverse event to the investigational product will be assessed by CTCAE v5.0 up to 3 months
Secondary SAE The relationship of each serious adverse event to the investigational product will be assessed by CTCAE v5.0 up to 3 months
Secondary blood pressure blood pressure will be measured by sphygmomanometer up to 1 months
Secondary respiratory rate respiratory rate will be measured by respiratory rate machine up to 1 months
Secondary ECG QT Interval 12-lead ECGs will be obtained during the study using an ECG machine predose up to 240 hours post-dose
Secondary t1/2 PK samples were collected according to the protocol requirements predose up to 240 hours post-dose
Secondary CL/F PK samples were collected according to the protocol requirements predose up to 240 hours post-dose
Secondary Vz/F PK samples were collected according to the protocol requirements predose up to 240 hours post-dose
See also
  Status Clinical Trial Phase
Completed NCT05483998 - A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants Phase 1
Recruiting NCT02235012 - Cognitive Biases Under Ketamine N/A
Recruiting NCT02417714 - Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
Completed NCT04418973 - Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject. N/A
Completed NCT05088343 - Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects Phase 1
Not yet recruiting NCT06248801 - Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets Phase 1
Terminated NCT04068259 - Single Ascending Dose Study of PBI-4547 in Healthy Subjects Phase 1
Completed NCT03279302 - Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects Phase 1
Not yet recruiting NCT06233162 - Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets Phase 1
Recruiting NCT04159844 - Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects N/A
Completed NCT06137911 - Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults. Phase 1
Completed NCT04849286 - Measurement of HTL0016878 in Cerebrospinal Fluid Phase 1
Not yet recruiting NCT06233227 - Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule Phase 1
Completed NCT04096157 - A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants Phase 1
Completed NCT01200368 - Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants Phase 3
Recruiting NCT05805033 - Peri-Implant Soft Tissue Integration in Humans: Influence of Material N/A
Completed NCT04027803 - Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris® Phase 1
Recruiting NCT03467880 - Multicenter Study of Impulse Oscillometry in Chinese N/A
Completed NCT02903095 - Single Ascending Dose Study of TD-1439 in Healthy Subjects Phase 1
Active, not recruiting NCT02341508 - A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers Phase 1