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Completed

NCT Number: NCT03306667

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

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.

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Key information

Conditions

Hepatic Insufficiency Digestive System Diseases Healthy Liver Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mochida Investigational sites

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

FYU-981

Drug

Oral single dosing

Primary outcomes

  1. Pharmacokinetics (Cmax: Maximum plasma concentration)

    Time frame: 48 hours

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

    Time frame: 48 hours

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

    Time frame: 48 hours

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

    Time frame: 48 hours

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

    Time frame: 48 hours

  6. Pharmacokinetics (kel: Elimination rate constant)

    Time frame: 48 hours

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

    Time frame: 48 hours

  8. Pharmacokinetics (MRT: Mean residence time)

    Time frame: 48 hours

  9. Pharmacodynamics (Serum concentration of uric acid)

    Time frame: 48 hours

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

    Time frame: 48 hours

  11. Safety (Incidence of treatment-emergent adverse events)

    Time frame: 192 hours

Sponsors and collaborators

Lead sponsor

Mochida Pharmaceutical Company, Ltd.

Industry

Collaborators

  • Fuji Yakuhin Co., Ltd.

Registry information

Official study title

Clinical Pharmacology Study of FYU-981 for Subjects With Hepatic Insufficiency

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 11, 2017
Registry last updated
Sep 24, 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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