Beijing GoBroad Boren Hospital
Beijing, Beijing Municipality, 100070, China
NCT Number: NCT05875493
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
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Beijing, Beijing Municipality, 100070, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 discrete single doses
Time frame: 31days
Area under the plasma concentration time curve of JAB-21822
Time frame: 31days
Area under the plasma concentration time curve of JAB-21822
Time frame: 31days
Highest observed plasma concentration of JAB-21822
Time frame: 31days
Time of highest observed plasma concentration of JAB-21822
Time frame: 31days
Elimination rate constant based on the terminal phase of unchanged form of JAB-21822
Time frame: 31days
Elimination half-life of unchanged form of JAB-21822
Time frame: 31days
Elimination lag-time of JAB-21822
Time frame: 31days
Apparent volume of distribution based on the terminal phase of unchanged form of JAB-21822
Time frame: 31days
Apparent total body clearance of unchanged form of JAB-21822
Time frame: 31days
Incidence,duration and severity of adverse events and serious adverse events according to NCI-CTCAE v5.0
Time frame: 31days
Abnormal values of lab parameters
Time frame: 31days
Prolongation of the QTc interval
Time frame: 31days
Abnormal values in systolic and diastolic blood pressure
Time frame: 31days
Abnormal values in pulse rate
Time frame: 31days
Abnormal values in respiratory rate
Time frame: 31days
Abnormal values of body temperature
Allist Pharmaceuticals, Inc.
Industry
A Phase I, Single-center, Randomized, Open-label, 2-cycle,2-period Crossover Study to Evaluate the Food Effect on the Pharmacokinetics of JAB-21822 in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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