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Completed

NCT Number: NCT02348307

Single Dose Phase I Study of FYU-981

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of FYU-981 administered orally to healthy male adults in fasted and fed conditions. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each step. After follow-up examination in the step of lower dose, the next dose is administered. The effect of food on PK/PD of FYU-981 is also investigated.

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Key information

Conditions

Healthy

Age range

20 year–35 year

Sex eligibility

Male

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 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

Treatment and study plan

FYU-981, (Oral single dosing)

Drug

Subjects randomized to the FYU-981 arm receive active drug, FYU-981.

Placebo, (Oral single dosing)

Drug

Subjects randomized to the placebo arm receive placebo.

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 (MRT: Mean residence time)

    Time frame: 48 hours

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

    Time frame: 48 hours

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

    Time frame: 48 hours

  10. Pharmacokinetics (CLr: Renal clearance)

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Fuji Yakuhin Co., Ltd.

Industry

Registry information

Official study title

Single Dose Clinical Pharmacological Study of FYU-981 Administered to Healthy Male Adults (Phase I Study).

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 28, 2015
Registry last updated
Jan 28, 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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