Development of a method to evaluate the function of metabolizing enzyme CYP1A2

UMIN ID: UMIN000049052

Registered date:01/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: healthy subject
• Date of first enrollment: 2022/10/01
• Target sample size: 18
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Caffeine intake from food

Outcome(s)

• Primary Outcome: Melatonin pharmacokinetic parameters (melatonin 6-hydroxy metabolic clearance, plasma 6-hydroxy melatonin/melatonin ratio)
• Secondary Outcome: Caffeine pharmacokinetic parameters (caffeine clearance, plasma caffeine/paraxanthine ratio)

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Persons who do not consume caffeine-containing products (coffee, tea, soft drinks) on a daily basis (2 to 3 times a week). 2) Persons who have experienced adverse reactions (palpitations, nausea, etc.) to caffeine-containing products (coffee, tea, soft drinks). Persons who are allergic to caffeine 3) Persons who have ever felt sick from blood sampling. 4) Persons who are under medical treatment, pregnant women or those who are thought to be pregnant or nursing 5) Persons who have subjective symptoms of hyperacidity on interview, persons who have been diagnosed with heart disease or gastric ulcer

Related Information

• Primary Sponsor: Tokyo University of Pharmacy and Life Sciences
• Source(s) of Monetary Support: None