NIPH Clinical Trials Search

Phase I Single-Administration Study of TKT001-S

Basic Information

Recruitment status	Complete
Health condition(s) or Problem(s) studied	Healthy adult males
Date of first enrollment	26/09/2023
Target sample size	16
Countries of recruitment
Study type	Interventional
Intervention(s)	Single dose of TKT001-S or TKT001-S placebo

Outcome(s)

Primary Outcome	-Phamacokinetics -Safety -Tolerability
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	< 45age old
Gender	Male
Include criteria	-Japanese healthy males between the age of 20 to under 45 years -Those who the BMI between 18.5 to under 28.0
Exclude criteria	-Those with illnesses that may affect the evaluation of the drug -History of hepatic, renal, or gastrointestinal or radiotherapy treatment that affects drug absorption -Those with a history or suspected history of alcohol or drug abuse