Skip to main content
OpenTrials
Completed

NCT Number: NCT02901366

Mass Balance Study of FYU-981

To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of FYU-981 after a single 1 mg oral dose of 14C-FYU-981 in healthy male subjects.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Male Subjects

Age range

20 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Japanese healthy adult subjects
  • Body mass index: >=18.5 and <25.0

Exclusion criteria

  • Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study
  • Have participated in a [14C]-study within the last 12 months prior to dosing of the investigational drug
  • Exposure to radiation for therapeutic or diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton) within the last 12 months prior to dosing of the investigational drug
  • Occupationally exposed worker

Treatment and study plan

14C-FYU-981

Drug

14C-FYU-981, (Oral single dosing)

Primary outcomes

  1. Pharmacokinetics (Cmax: Maximum plasma concentration)

    Time frame: 168 hours

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

    Time frame: 168 hours

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

    Time frame: 168 hours

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

    Time frame: 168 hours

  5. Pharmacokinetics (kel: Elimination rate constant)

    Time frame: 168 hours

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

    Time frame: 168 hours

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

    Time frame: 168 hours

  8. Pharmacokinetics (MRT: Mean residence time)

    Time frame: 168 hours

  9. Pharmacokinetics (Ae(urine), Ae(feces) and Ae(air): Amount of radioactivity excreted in urine, feces, or air)

    Time frame: 168 hours or 72 hours (Ae(air))

  10. Pharmacokinetics (fe(urine) , fe(feces) and fe(air): Fraction of radioactivity excreted in urine, feces, or air)

    Time frame: 168 hours or 72 hours (Ae(air))

  11. Pharmacokinetics (Ae(total): Total amount of radioactivity excreted)

    Time frame: 168 hours

  12. Pharmacokinetics (fe(total): Total fraction of radioactivity excreted)

    Time frame: 168 hours

  13. Pharmacokinetics (Ae(urine + air): Amount of radioactivity excreted in urine and air)

    Time frame: 168 hours

  14. Pharmacokinetics (fe(urine + air): Fraction of radioactivity excreted in urine and air)

    Time frame: 168 hours

  15. Pharmacokinetics (Ratios of FYU-981 and its metabolites in plasma, urine and feces)

    Time frame: 168 hours

Sponsors and collaborators

Lead sponsor

Fuji Yakuhin Co., Ltd.

Industry

Collaborators

  • Mochida Pharmaceutical Company, Ltd.

Registry information

Official study title

Plasma Concentration, Excretion and Mass Balance Orally Administered 14C-FYU-981 in Healthy Male Subjects

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Sep 15, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.