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Mass Balance Study of FYU-981

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ClinicalTrials.gov Identifier: NCT02901366
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
Mochida Pharmaceutical Company, Ltd.
Information provided by (Responsible Party):
Fuji Yakuhin Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Healthy Male Subjects Drug: 14C-FYU-981 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Plasma Concentration, Excretion and Mass Balance Orally Administered 14C-FYU-981 in Healthy Male Subjects
Study Start Date : September 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: 14C-FYU-981
14C-FYU-981, (Oral single dosing)
Drug: 14C-FYU-981
14C-FYU-981, (Oral single dosing)




Primary Outcome Measures :
  1. Pharmacokinetics (Cmax: Maximum plasma concentration) [ Time Frame: 168 hours ]
  2. Pharmacokinetics (AUC: Area under the plasma concentration-time curve) [ Time Frame: 168 hours ]
  3. Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) [ Time Frame: 168 hours ]
  4. Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) [ Time Frame: 168 hours ]
  5. Pharmacokinetics (kel: Elimination rate constant) [ Time Frame: 168 hours ]
  6. Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed [ Time Frame: 168 hours ]
  7. Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed) [ Time Frame: 168 hours ]
  8. Pharmacokinetics (MRT: Mean residence time) [ Time Frame: 168 hours ]
  9. Pharmacokinetics (Ae(urine), Ae(feces) and Ae(air): Amount of radioactivity excreted in urine, feces, or air) [ Time Frame: 168 hours or 72 hours (Ae(air)) ]
  10. Pharmacokinetics (fe(urine) , fe(feces) and fe(air): Fraction of radioactivity excreted in urine, feces, or air) [ Time Frame: 168 hours or 72 hours (Ae(air)) ]
  11. Pharmacokinetics (Ae(total): Total amount of radioactivity excreted) [ Time Frame: 168 hours ]
  12. Pharmacokinetics (fe(total): Total fraction of radioactivity excreted) [ Time Frame: 168 hours ]
  13. Pharmacokinetics (Ae(urine + air): Amount of radioactivity excreted in urine and air) [ Time Frame: 168 hours ]
  14. Pharmacokinetics (fe(urine + air): Fraction of radioactivity excreted in urine and air) [ Time Frame: 168 hours ]
  15. Pharmacokinetics (Ratios of FYU-981 and its metabolites in plasma, urine and feces) [ Time Frame: 168 hours ]


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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
  • 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

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): NCT02901366


Locations
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Japan
Tokyo, Japan
Sponsors and Collaborators
Fuji Yakuhin Co., Ltd.
Mochida Pharmaceutical Company, Ltd.

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Responsible Party: Fuji Yakuhin Co., Ltd.
ClinicalTrials.gov Identifier: NCT02901366    
Other Study ID Numbers: FYU-981-009
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Keywords provided by Fuji Yakuhin Co., Ltd.:
Mass balance