Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)

Mochida Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy; Hepatic Insufficiency

Treatments: Drug: FYU-981

Study type: Interventional

Funder types: Industry

Identifiers

NCT03306667

FYU-981-015

Details and patient eligibility

About

The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with hepatic insufficiency and with normal hepatic function.

Enrollment: 24 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult healthy subjects or adult cirrhosis patients
• Body mass index: >=18.5 and <30.0

Exclusion criteria

• Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study (except for cirrhosis patients with hepatic diseases)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 4 patient groups

Normal group

Experimental group

Description:

Healthy control subjects

Treatment:

Drug: FYU-981

Mild hepatic-insufficient group

Experimental group

Description:

Patients with mild hepatic impaired function (Child-Pugh A)

Treatment:

Drug: FYU-981

Moderate hepatic-insufficient group

Experimental group

Description:

Patients with moderate hepatic impaired function (Child-Pugh B)

Treatment:

Drug: FYU-981

Severe hepatic-insufficient group

Experimental group

Description:

Patients with severe hepatic impaired function (Child-Pugh C)

Treatment:

Drug: FYU-981