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Completed

NCT Number: NCT02837198

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

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.

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Key information

Conditions

Hyperuricemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FYU-981

Drug

Topiroxostat

Drug

Other names: FYX-051

Primary outcomes

  1. Pharmacodynamics (Amount of uric acid excreted in urine)

    Time frame: 1-, 2-, 3-, 4-, 5-, 6-,7-,8- and 9-day

  2. Pharmacodynamics (Renal clearance of uric acid)

    Time frame: 1-, 4- and 7-day

  3. Pharmacodynamics (Fractional uric acid excretion)

    Time frame: 4- and 7-day

  4. Pharmacodynamics (Maximum delta effective uric acid concentration)

    Time frame: 1-, 2-, 3-, 4-, 5-, 6- and 7-day

  5. Pharmacodynamics (Delta area under the serum uric acid concentration-time curve)

    Time frame: 1-, 4- and 7-day

Secondary outcomes

  1. Pharmacokinetics (Cmax: Maximum plasma concentration)

    Time frame: 1-, and 7-day

  2. Pharmacokinetics (Cmin: Minimum plasma concentration)

    Time frame: 1-, 2-, 3-, 4-, 5-, 6- and 7-day

  3. Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)

    Time frame: 1-, and 7-day

  4. Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)

    Time frame: 1-, and 7-day

  5. Pharmacokinetics (AUC: Area under the plasma concentration-time curve)

    Time frame: 1-, and 7-day

  6. Pharmacokinetics (kel: Elimination rate constant)

    Time frame: 1-, and 7-day

  7. Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)

    Time frame: 1-, and 7-day

  8. Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)

    Time frame: 1-, and 7-day

  9. Pharmacokinetics (MRT: Mean residence time)

    Time frame: 1-, and 7-day

Sponsors and collaborators

Lead sponsor

Fuji Yakuhin Co., Ltd.

Industry

Registry information

Official study title

Seven-day Repeated Dose Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemia

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 19, 2016
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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