chronic kidney disease
Conditions
Interventions
- Oral administration of AK1960
- Oral administration of a CYP2C9 inhibitor and AK1960
Sponsors
Yamaguchi Seika
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteer part - Who are able to fully understand the contents of the clinical trial and are capable of providing written consent. - Healthy men and women (women who are not capable of becoming pregnant) - Who do not have the 430C>T mutation and the 1075A>C mutation in the CYP2C9 gene Patients part - Who are able to fully understand the contents of the clinical trial and are capable of providing written consent. - Patients diagnosed with chronic kidney disease - Who do not have the 430C>T mutation and the 1075A>C mutation in the CYP2C9 gene
Exclusion criteria
Exclusion criteria: Healthy volunteer part - Subjects with clinical abnormalities in laboratory tests, vital signs, or fixed 12-lead electrocardiogram (ECG) - Subjects under 50.0 kg in men, less than 45.0 kg in women - Subjects with a BM of 1 (Japanese men: less than 18.5 kg/m2 or greater than 25.0 kg/m2; Japanese women: less than 17.5 kg/m2 or greater than 25.0 kg/m2; Caucasian: less than 18.5 kg/m2 or greater than 30.0 kg/m2) Patients part - Patients with rapidly progressing and unstable kidney disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic endpoints: Pharmacokinetic parameters Safety endpoints: Adverse events, vital signs, clinical tests Efficacy endpoints: Urinary protein, urinary albumin | — |
Contacts
Public ContactContact for Clinical Trial Information
ASAHI KASEI THERAPEUTICS CORPORATION
Outcome results
None listed