Exploratory research using existing sample and information on the effect of M201-A on renal function

Exploratory research using existing sample and information on the effect of M201-A on renal function - M201-A-CR-001

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000034717

Enrollment

Registered

2018-10-31

Start date

2018-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteer

Interventions

None listed

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: -Japanese Healthy Male subjects -Age 20 to less than 40 years of age -Body Mass Index (BMI) of 18.5 to less than 25.0 kg/m2 -Written informed consent must be obtained on a voluntary basis before any assessment is performed.

Exclusion criteria

Exclusion criteria: -Presence or past medical history of hepatic impairments, renal impairments, cardiovascular disease, gastrointestinal disease and others which are inappropriate for participating in this clinical trial -Past medical history of cancer, cerebral infarction or cardiac infarction -Presence or past medical history of allergic reactions or idiosyncrasies to food, medicinal substance and metallic materials -QTcF > 450ms at the screening examination -NT-proBNP > 125 pg/mL at the screening examination -Any risk factors of Torsades de Pointes including such as heart failure, hypokalemia, long QT interval syndrome due to family medical history

Design outcomes

Primary

Measure	Time frame
Blood Na, K, Cl, Creatinine Urine Na, K, Cl, Creatinine	—

Countries

Japan

Contacts

Public ContactMika MAEDA

Kitasato University Hospital THE KITASATO INSTITUTE Department of Pharmacy

m-maeda@kitasato-u.ac.jp042-778-9775

Outcome results