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Clinical Pharmacology of FYU-981 (Final Formulation)

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ClinicalTrials.gov Identifier: NCT03350373
Recruitment Status : Completed
First Posted : November 22, 2017
Last Update Posted : December 12, 2017
Sponsor:
Collaborator:
Fuji Yakuhin Co., Ltd.
Information provided by (Responsible Party):
Mochida Pharmaceutical Company, Ltd.

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
Healthy Drug: FYU-981 Phase 1

Study Type : Interventional  (Clinical Trial)
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 : November 6, 2017
Actual Primary Completion Date : November 29, 2017
Actual Study Completion Date : November 29, 2017

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 Name: 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 Name: Final formulation of FYU-981




Primary Outcome Measures :
  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 [ Time Frame: 48 hours ]
    T1/2: Elimination half-life of plasma concentration

  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 (Vd/F: Distribution volume/Fraction of dose absorbed) [ Time Frame: 48 hours ]
  8. Pharmacokinetics (MRT: Mean residence time) [ Time Frame: 48 hours ]
  9. Safety (Incidence of treatment-emergent adverse events) [ Time Frame: 13 days ]


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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03350373


Locations
Japan
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

Responsible Party: Mochida Pharmaceutical Company, Ltd.
ClinicalTrials.gov Identifier: NCT03350373     History of Changes
Other Study ID Numbers: FYU-981-016
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No