Phase 1 study of DS-3201b to evaluate the effect of food (low-fat meal) on the pharmacokinetics in healthy subjects

JRCT ID: jRCT2071200043

Registered date:13/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy subjects
• Date of first enrollment: 31/10/2020
• Target sample size: 28
• Study type: Interventional
• Intervention(s): Oral administration

Outcome(s)

Primary Outcome

Pharmacokinetic parameters of plasma concentration of total DS-3201a:
Cmax, AUClast, AUCinf

Secondary Outcome

PK:
Plasma PK parameters for DS-3201a (total and unbound concentrations)
Safety:
AEs, laboratory data, body weight, vital signs, and 12-lead ECGs

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Both

Include criteria

1. Gender:males or females
2. Age: >=20 and =<45 years (at the time of informed consent)
3. Body mass index (BMI) = Body weight (kg) / (Height [m])2: >=18.5 and <25.0 (at screening)

Exclude criteria

1. Having a history of hypersensitivity to any drugs or substances, or being idiosyncratic (eg, having penicillin allergy)
2. Having alcohol or drug dependence etc.

Related Information

• Primary Sponsor: Nagao Kiminori