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

Hyperuricemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02837198
• Other study ID #: FYU-981-008
• Status: Completed
• Phase: Phase 2
• Start date: July 2016
• Est. completion date: March 2018

Study information

• Verified date: August 2018
• Source: Fuji Yakuhin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperuricemia

Intervention

Drug:
• FYU-981

• Topiroxostat

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fuji Yakuhin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamics (Amount of uric acid excreted in urine)		1-, 2-, 3-, 4-, 5-, 6-,7-,8- and 9-day
Primary	Pharmacodynamics (Renal clearance of uric acid)		1-, 4- and 7-day
Primary	Pharmacodynamics (Fractional uric acid excretion)		4- and 7-day
Primary	Pharmacodynamics (Maximum delta effective uric acid concentration)		1-, 2-, 3-, 4-, 5-, 6- and 7-day
Primary	Pharmacodynamics (Delta area under the serum uric acid concentration-time curve)		1-, 4- and 7-day
Secondary	Pharmacokinetics (Cmax: Maximum plasma concentration)		1-, and 7-day
Secondary	Pharmacokinetics (Cmin: Minimum plasma concentration)		1-, 2-, 3-, 4-, 5-, 6- and 7-day
Secondary	Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)		1-, and 7-day
Secondary	Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)		1-, and 7-day
Secondary	Pharmacokinetics (AUC: Area under the plasma concentration-time curve)		1-, and 7-day
Secondary	Pharmacokinetics (kel: Elimination rate constant)		1-, and 7-day
Secondary	Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)		1-, and 7-day
Secondary	Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)		1-, and 7-day
Secondary	Pharmacokinetics (MRT: Mean residence time)		1-, and 7-day