Clinical Pharmacology of FYU-981 (Final Formulation)

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03350373
• Other study ID #: FYU-981-016
• Status: Completed
• Phase: Phase 1
• First received: November 19, 2017
• Last updated: December 11, 2017
• Start date: November 6, 2017
• Est. completion date: November 29, 2017

Study information

• Verified date: November 2017
• Source: Mochida Pharmaceutical Company, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 29, 2017
• Est. primary completion date: November 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Japan	P-One Clinic	Hachioji	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Mochida Pharmaceutical Company, Ltd.	Fuji Yakuhin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (Cmax: Maximum plasma concentration)		48 hours
Primary	Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)		48 hours
Primary	Pharmacokinetics	T1/2: Elimination half-life of plasma concentration	48 hours
Primary	Pharmacokinetics (AUC: Area under the plasma concentration-time curve)		48 hours
Primary	Pharmacokinetics (CLtot/F: Total clearance/Fraction of dose absorbed)		48 hours
Primary	Pharmacokinetics (kel: Elimination rate constant)		48 hours
Primary	Pharmacokinetics (Vd/F: Distribution volume/Fraction of dose absorbed)		48 hours
Primary	Pharmacokinetics (MRT: Mean residence time)		48 hours
Primary	Safety (Incidence of treatment-emergent adverse events)		13 days