Food Effect in Healthy Participants
Conditions
Brief summary
The primary objective of this study is to determine the effect of food in healthy participants on the bioavailability of JAB-21822 following single dose administration with and without a meal
Detailed description
This is an open-label,randomized, 2-cycle,2-period crossover,food effect study. On Day 1 of each period, subjects will receive a single oral dose of JAB-21822 administered either under fasting conditions or following a standardized high-fat/high-calorie meal. PK sampling for JAB-21822 will be collected predose and postdose. There will be a washout period between doses.
Interventions
DRUGJAB-21822
2 discrete single doses
Sponsors
Allist Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an open-label,randomized, 2-cycle,2-period crossover,food effect study
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female , between 18 and 45 years of age * Bodyweight (male) ≥50kg, Bodyweight (Female) ≥45kg；BMI within the range of 19 to 25 kg/m2, inclusive * No clinically significant abnormalities identified in the judgement of investigator at screening * Written informed consent prior to any study specific procedures
Exclusion criteria
* History of clinically significant disease or disorder * History of interstitial pneumonia, pulmonary fibrosis, and other interstitial lung diseases * History of dysphagia or any gastrointestinal disease that would potentially alter absorption of drug * COVID-19 positive at screening or baseline * Allergic to JAB-21822 and any of the tablet's ingredients, history of hypersensitivity or allergy to drug or food * Received surgical procedure within 3 months at screening * Blood donation within the 3 months or planing to donate during the study * Participated in another clinical trial of biological agents within 6 months at screening, or any other clinical trial within 3 months at screening * History of drug abuse or positive urine drug test * Received the vaccine within 3 months at screening or planning to receive during the study * Overtake of achole,tea and coffee prior to first dosing and unable to control during the study * Special dietary requirements or unable to control during the study * HIV, HBV, HCV, and syphilis positive * Pregnant or breast-feeding women or positive of blood pregnancy test * Subjects who are considered to be unacceptable in this study under the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under plasma concentration (AUC) 0 to∞ | 31days | Area under the plasma concentration time curve of JAB-21822 |
| Area under plasma concentration (AUC) 0 to t | 31days | Area under the plasma concentration time curve of JAB-21822 |
| Plasma concentration ( Cmax) | 31days | Highest observed plasma concentration of JAB-21822 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absorption lag-time (Tlag) | 31days | Elimination lag-time of JAB-21822 |
| Apparent volume of distribution (Vz/F) | 31days | Apparent volume of distribution based on the terminal phase of unchanged form of JAB-21822 |
| Apparent clearance (CL/F) | 31days | Apparent total body clearance of unchanged form of JAB-21822 |
| Number of participants with adverse events (AEs) and serious adverse events(SAEs) | 31days | Incidence,duration and severity of adverse events and serious adverse events according to NCI-CTCAE v5.0 |
| Number of subjects with abnormal lab parameters | 31days | Abnormal values of lab parameters |
| Time to achieve Cmax (Tmax) | 31days | Time of highest observed plasma concentration of JAB-21822 |
| Number of subjects with abnormal systolic and diastolic blood pressure | 31days | Abnormal values in systolic and diastolic blood pressure |
| Number of subjects with abnormal pulse rate | 31days | Abnormal values in pulse rate |
| Number of subjects with abnormal respiratory rate | 31days | Abnormal values in respiratory rate |
| Number of subjects with abnormal body temperature | 31days | Abnormal values of body temperature |
| Number of subjects with abnormal electrocardiogram (12-lead ECG) | 31days | Prolongation of the QTc interval |
| Elimination rate constant (λz) | 31days | Elimination rate constant based on the terminal phase of unchanged form of JAB-21822 |
| Concentration half-life (T1/2) | 31days | Elimination half-life of unchanged form of JAB-21822 |
Countries
China
Outcome results
None listed