NCT02901366

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

4 months

First QC Date

September 12, 2016

Last Update Submit

August 20, 2018

Conditions

Healthy Male Subjects

Keywords

Mass balance

Outcome Measures

Primary Outcomes (15)

  • Pharmacokinetics (Cmax: Maximum plasma concentration)

    168 hours

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

    168 hours

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

    168 hours

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

    168 hours

  • Pharmacokinetics (kel: Elimination rate constant)

    168 hours

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

    168 hours

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

    168 hours

  • Pharmacokinetics (MRT: Mean residence time)

    168 hours

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

    168 hours or 72 hours (Ae(air))

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

    168 hours or 72 hours (Ae(air))

  • Pharmacokinetics (Ae(total): Total amount of radioactivity excreted)

    168 hours

  • Pharmacokinetics (fe(total): Total fraction of radioactivity excreted)

    168 hours

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

    168 hours

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

    168 hours

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

    168 hours

Study Arms (1)

14C-FYU-981

EXPERIMENTAL

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

Drug: 14C-FYU-981

Interventions

14C-FYU-981DRUG

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

14C-FYU-981

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 15, 2016

Study Start

September 1, 2016

Primary Completion

January 1, 2017

Study Completion

July 1, 2018

Last Updated

August 21, 2018

Record last verified: 2018-08

Locations

JP(1)