Study of FYU-981 in Hyperuricemia (Effect on Two Hyperuricemic Types)

Fuji Yakuhin

Status and phase: Completed; Phase 2

Conditions: Hyperuricemia

Treatments: Drug: FYU-981; Drug: Topiroxostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT02837198

FYU-981-008

Details and patient eligibility

About

To investigate the pharmacodynamics, pharmacokinetics and safety of 7-day-repeated doses of FYU-981 administered orally to male hyperuricemic patients with uric acid-overproduction or uric acid-underexcretion type.

In addition, to investigate the additive effects of the combination of FYU-981 and topiroxostat administered orally to male hyperuricemic patients with uric acid-overproduction type.

Enrollment: 24 patients

Sex: Male

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Japanese adult subjects
• Serum urate level: >= 7.0mg/dL in patients
• Disease Type: Uric acid-overproduction Type or Uric acid-underexcretion Type

Exclusion criteria

• Gouty arthritis within a year before start of study treatment
• Mixed type in the classification of hyperuricemia

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Uric acid-overproduction Type

Experimental group

Description:

FYU-981

Treatment:

Drug: FYU-981

Uric acid- underexcretion Type

Experimental group

Description:

FYU-981

Treatment:

Drug: FYU-981

Uric acid-overproduction Type (combination)

Experimental group

Description:

FYU-981 , Topiroxostat

Treatment:

Drug: Topiroxostat

Drug: FYU-981

Uric acid- underexcretion Type2

Experimental group

Description:

FYU-981

Treatment:

Drug: FYU-981