Phase I Single-Administration Study of TKT001-S

JRCT ID: jRCT2071230046

Registered date:25/07/2023

Basic Information

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

Outcome(s)

Primary Outcome

-Phamacokinetics
-Safety
-Tolerability

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

Related Information

• Primary Sponsor: Kai Megumi