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Clinical Pharmacology study for AS-3201 in renal impairment subjects

Clinical Pharmacology study for AS-3201 in renal impairment subjects

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222701
Enrollment
24
Registered
2014-12-22
Start date
2014-12-22
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

renal impairment subjects

Interventions

Sponsors

Sumitomo Dainippon Pharmaceuticals Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Subjects who provided written voluntary consent to participate in the study -eGFR < 60 mL/min/1.73 m2 (renal impairment subjects) -45.0 kg =< body weight =< 80.0 kg and 18.5 kg/m2 =< BMI <30.0 kg/m2

Exclusion criteria

Exclusion criteria: -Subjects who have a serious complication -Subjects who received an AS-3201 Etc

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics Cmax, AUC, etc.

Secondary

MeasureTime frame
Safety Clinical laboratory test, vital sign, 12-lead ECG, etc.

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026