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NCT Number: NCT03350373

Clinical Pharmacology of FYU-981 (Final Formulation)

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.

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Key information

Conditions

Healthy

Age range

20 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

P-One Clinic

Hachiōji, Tokyo, 192-0071, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FYU-981

Drug

Single administration of FYU-981 under Fasted and fed conditions in the morning.

Other names: Final formulation of FYU-981

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mochida Pharmaceutical Company, Ltd.

Industry

Collaborators

  • Fuji Yakuhin Co., Ltd.

Registry information

Official study title

Clinical Pharmacology Study of Final Formulation of FYU-981 Administered to Healthy Male Adults

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 22, 2017
Registry last updated
Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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