Jiangnan University Affiliated Hospital
Wuxi, Jiangsu, 214062, China
NCT Number: NCT07007546
To main objective is to evaluate the safety, tolerability, and pharmacokinetic profile of single or multiple oral doses of ABSK061 mini-tablets and to evaluate the effect of soft food with ABSK061 mini-tablets on its pharmacokinetic profile in healthy adult participants
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Wuxi, Jiangsu, 214062, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A total of 18 healthy participants were planned to be enrolled in Part I and randomized 1: 1: 1 to Sequences A, B, and C. Participants in three sequences received a single dose of ABSK061 at doses of 1 mg, 10 mg, and 35 mg.
Time frame: Up to 48 hours post-dose
maximum plasma concentration (Cmax)
Time frame: Up to 24 hours post-dose
maximum steady-state plasma concentration (Cmax)
Time frame: Up to 24 hours post-dose
average steady-state trough plasma concentration (Cmin)
Time frame: Up to 48 hours post-dose
time to reach maximum plasma concentration (Tmax)
Time frame: Up to 48 hours post-dose
area under the plasma concentration-time curve (AUC)
Time frame: Up to 24 hours post-dose
accumulation ratio for AUC
Time frame: Up to 24 hours post-dose
accumulation ratio for Cmax (RCmax)
Time frame: Initiation of study treatment up to 18-days post treatment
number of participants with adverse events (AEs), serious adverse events (SAEs), as a measure of safety and tolerability
Time frame: Initiation of study treatment up to 18-days post treatment
Frequency in changes in laboratory parameters and physical signs of toxicity
Time frame: Up to 48 hours post-dose
apparent total clearance (CL/F)
Time frame: Up to 48 hours post-dose
apparent volume of distribution (Vz/F)
Time frame: Up to 48 hours post-dose
half-life of ABSK061
Abbisko Therapeutics Co, Ltd
Industry
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single or Multiple Oral Doses of ABSK061 Mini-tablets and to Evaluate the Effect of Soft Food With ABSK061 Mini-tablets on Its Pharmacokinetic Profile in Healthy Adult Participants
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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