Trial | NCT02348307  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    dotinurad ...

  • Study Participants

    54
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.
Study Started
Mar 31
2013
Primary Completion
Jun 30
2013
Study Completion
Aug 31
2013
Last Update
Jan 28
2015
Estimate

Drug FYU-981, (Oral single dosing)

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

Drug Placebo, (Oral single dosing)

Subjects randomized to the placebo arm receive placebo.

FYU-981 Active Comparator

Placebo Placebo Comparator

Criteria 

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
No Results Posted