Clincosm LogoSign in Get a demo

Clinical Pharmacology of FYU-981 (Final Formulation)

Sponsor
Mochida Pharmaceutical Company, Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03350373
Collaborator
Fuji Yakuhin Co., Ltd. (Industry)
12
Enrollment
1
Location
2
Arms
23
Actual Duration (Days)
15.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized, open-label, 2-period crossover study. The purpose of this study is to assess the pharmacokinetics and safety after single oral administration of final formulation of FYU-981 to healthy male adults in fasted and fed conditions. Participants are randomized to fasted (n=6) or fed conditions (n=6) in each step. The effect of food to pharmacokinetics of FYU-981 is also investigated.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Clinical Pharmacology Study of Final Formulation of FYU-981 Administered to Healthy Male Adults
Actual Study Start Date :
Nov 6, 2017
Actual Primary Completion Date :
Nov 29, 2017
Actual Study Completion Date :
Nov 29, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fasted dosing followed by fed dosing

Dosing of FYU-981 in the fasted state followed by fed dosing

Drug: FYU-981
Single administration of FYU-981 under Fasted and fed conditions in the morning.
Other Names:
  • Final formulation of FYU-981

    		•
    Experimental: Fed dosing followed by fasted dosing

    Dosing of FYU-981 in the fed state followed by fasted dosing

    Drug: FYU-981
    Single administration of FYU-981 under Fasted and fed conditions in the morning.
    Other Names:
  • Final formulation of FYU-981

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (Cmax: Maximum plasma concentration) [48 hours]

    2. Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) [48 hours]

    3. Pharmacokinetics [48 hours]

      T1/2: Elimination half-life of plasma concentration

    4. Pharmacokinetics (AUC: Area under the plasma concentration-time curve) [48 hours]

    5. Pharmacokinetics (CLtot/F: Total clearance/Fraction of dose absorbed) [48 hours]

    6. Pharmacokinetics (kel: Elimination rate constant) [48 hours]

    7. Pharmacokinetics (Vd/F: Distribution volume/Fraction of dose absorbed) [48 hours]

    8. Pharmacokinetics (MRT: Mean residence time) [48 hours]

    9. Safety (Incidence of treatment-emergent adverse events) [13 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    Male
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 P-One Clinic Hachiōji Tokyo Japan 192-0071

    Sponsors and Collaborators

    • Mochida Pharmaceutical Company, Ltd.
    • Fuji Yakuhin Co., Ltd.

    Investigators

    • Study Director: Katsuaki Nagasawa, Clinical Research Department

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mochida Pharmaceutical Company, Ltd.
    ClinicalTrials.gov Identifier:
    NCT03350373
    Other Study ID Numbers:
    • FYU-981-016
    First Posted:
    Nov 22, 2017
    Last Update Posted:
    Dec 12, 2017
    Last Verified:
    Nov 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dotinurad

    Study Results

    No Results Posted as of Dec 12, 2017