Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, Jilin, 130103, China
NCT Number: NCT05982106
TQ05105 is a class 1 new drug with a new chemical structure developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. It is a Janus Kinase 2 (JAK2)inhibitor and can be used to treat JAK2 target-related diseases. This study is a randomized, open-label, single-center, two-cycle, two-crossover Phase I clinical trial evaluating the effect of food on the pharmacokinetics of TQ05105 tablets in healthy adult subjects. Pharmacokinetic effects and safety after oral administration of TQ05105 tablets.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Changchun, Jilin, 130103, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TQ05105 tablet is a novel JAK2 inhibitor.
Time frame: 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration
Area under the drug-time curve
Time frame: 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration
Maximum concentration
Time frame: 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration
Time to maximum concentration following drug administration
Time frame: 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration
Apparent terminal elimination half-life following drug administration
Time frame: 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration
Apparent volume of distribution
Time frame: 1 hour before administration and 10, 20, 30, 45 minuets, 1, 1.5, 2, 2.5, 3 ,3.5, 4, 6, 8, 12, 24 hours after administration
Clearance rate
Time frame: Baseline up to 24 hours after administration
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time frame: 1 hour before administration and 1, 4, 12, 24 hours after administration
Monitor the safety indicators of subjects during the trial
Time frame: 1 hour before administration and 1, 4, 12, 24 hours after administration
Monitor the safety indicators of subjects during the trial
Time frame: 1 hour before administration and 1, 4, 12, 24 hours after administration
Monitor the safety indicators of subjects during the trial
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Industry
A Randomized, Open-label, Single-center, Two-cycle, Two-crossover Phase I Clinical Trial Evaluating the Effect of Food on the Pharmacokinetics of TQ05105 Tablets in Healthy Adult 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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