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Completed

NCT Number: NCT02344875

Clinical Pharmacology of FYU-981 (Elder Subjects)

The purpose of this study is to assess the pharmacokinetics, safety and pharmacodynamics after single oral administration of FYU-981 to male and female elder subjects in comparison with non-elder subjects.

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Key information

Conditions

Healthy

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Japan

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Japanese adult subjects
  • 20-35 Years (non-elder groups)
  • 65- Years (elder groups)
  • 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

Treatment and study plan

FYU-981, (Oral single dosing)

Drug

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. Pharmacokinetics (Ae: Amount of drug excreted in urine)

    Time frame: 48 hours

  10. Pharmacokinetics (fe: Fraction of dose excreted in urine)

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Fuji Yakuhin Co., Ltd.

Industry

Registry information

Official study title

Clinical Pharmacological Study of FYU-981 Administered to Male and Female Elder or Non-elder Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 26, 2015
Registry last updated
Jan 26, 2015

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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