Repeated Dose Phase I Study of FYU-981

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02348333

Enrollment

Registered

2015-01-28

Start date

2013-09-30

Completion date

2013-12-31

Last updated

2015-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of 7-day-repeated doses of FYU-981 administered orally to healthy male adults once daily. 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.

Interventions

DRUGFYU-981, (Oral daily dosing for 7 days)

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

DRUGPlacebo, (Oral daily dosing for 7 days)

Subjects randomized to the placebo arm receive placebo.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to 35 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics (Cmax: Maximum plasma concentration)	1-, 4-, and 7-day
Pharmacokinetics (Cmin: Minimum plasma concentration)	1-, 2-, 3-, 4-, 5-, 6- and 7-day
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)	1-, 4-, and 7-day
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)	1-, 4-, and 7-day
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)	1-, 4-, and 7-day
Pharmacokinetics (Rauc: Accumulation ratio of AUC0-24)	4-, and 7-day
Pharmacokinetics (kel: Elimination rate constant)	1-, 4-, and 7-day
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)	1-, 4-, and 7-day
Pharmacokinetics (Ae: Amount of drug excreted in urine)	9 days
Pharmacokinetics (fe: Fraction of dose excreted in urine)	9 days

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026