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

• Status: Completed
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fuji Yakuhin Co., Ltd.
• Treatments: Dotinurad; FYX-051; Uric Acid

Criteria

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