A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Metformin

Healthy Subjects Clinical Trial

Official title:

ASP015K Pharmacokinetic Study: Evaluation of Drug-Drug Interaction Between ASP015K and Metformin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02760342
• Other study ID #: 015K-CL-PK20
• Status: Completed
• Phase: Phase 1
• Start date: May 15, 2016
• Est. completion date: June 26, 2016

Study information

• Verified date: September 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the pharmacokinetic interactions between ASP015K and metformin in healthy non-elderly male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 26, 2016
• Est. primary completion date: June 26, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 44 Years

Eligibility

Inclusion Criteria:

• Body weight at screening: = 50.0 kg, < 80.0 kg

• BMI at screening: = 17.6, < 26.4

• Subjects who agree to use highly effective contraception as consisting of two forms of birth control (at least one of which must be a barrier method) from getting informed consent through 90 days after the final study drug administration.

• Subjects who agree NOT to donate sperm from getting informed consent through 90 days after the final study drug administration.

Exclusion Criteria:

• Subjects who received or are scheduled to receive any investigational drugs in other clinical trials or post-marketing studies within 120 days before screening test or during the screening test to the hospital admission (Day -1).

• Subjects who received or is scheduled to receive any medications (including over-the-counter drugs) within seven days before the hospital admission (Day -1).

• Subjects who received ASP015K or metformin previously.

• Subjects who have a habit of excessive alcohol drinking or smoking.

• Any deviation from the normal range of blood pressure, pulse, body temperature, or 12-lead ECG at screening or on the day of hospital admission (Day -1).

• Subjects who meet any of the following criterion for laboratory tests at screening or on the day of hospital admission (Day -1). Normal ranges of each test specified at the study site or test/assay organization will be used as the normal ranges in this study.

• Subjects with a complication or history of drug allergies.

• Subjects who have a history of clinically serious allergy, which induces generalized urticaria or anaphylactic shock requiring hospital admission.

• Subjects with a complication or history of hepatic disease, renal disease, cardiac disease, congenital short QT syndrome, respiratory disease , gastrointestinal disease.

• Subjects with a history of gastrointestinal resection.

• Subjects who developed upper gastrointestinal symptoms within seven days before the hospital admission (Day -1).

• Subjects with a complication or history of endocrine disease, cerebrovascular disease, malignant tumor, lymphatic disease , lactic acidosis.

• Subjects who apply to any of the concerns with regard to tuberculosis.

• Subjects who apply to any of the concerns with regard to infection other than tuberculosis.

• Subjects with vaccination of live vaccines or live attenuated vaccines within 56 days before the hospital admission (Day -1).

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• peficitinib
Oral
• Metformin
Oral

Locations

Country	Name	City	State
Japan	Site JP00001	Kagoshima

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK) parameter of metformin in plasma: AUCinf	AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity	Up to Day 12
Primary	PK parameter of metformin in plasma: Cmax	Cmax: Maximum concentration	Up to Day 12
Primary	PK parameter of metformin in plasma: AUClast	AUClast: Area under the concentration-time curve from the time of dosing to the last measurable concentration	Up to Day 12
Secondary	PK parameter of metformin in plasma: CL/F	CL/F: Apparent total systemic clearance	Up to Day 12
Secondary	PK parameter of metformin in plasma: t1/2	t1/2: Terminal elimination half-life	Up to Day 12
Secondary	PK parameter of metformin in plasma: tmax	tmax: Time of Cmax	Up to Day 12
Secondary	PK parameter of metformin in plasma: Vz/F	Vz/F: Apparent volume of distribution during the terminal elimination phase	Up to Day 12
Secondary	PK parameter of metformin in urine: Aelast	Aelast: Amount of metformin excreted into the urine from the time of dosing to the last measurable concentration	Up to Day 12
Secondary	PK parameter of metformin in urine: Aelast%	Aelast%: Percent of metformin excreted into the urine from the time of dosing to the last measurable concentration	Up to Day 12
Secondary	PK parameter of metformin in urine: CLR	CLR: Renal clearance	Up to Day 12
Secondary	PK parameter of ASP015K in plasma: AUCinf		Up to Day 12
Secondary	PK parameter of ASP015K in plasma: AUClast		Up to Day 12
Secondary	PK parameter of ASP015K in plasma: AUCtau	AUCtau: Area under the concentration-time curve from the time of dosing to the start of the next dosing interval	Up to Day 12
Secondary	PK parameter of ASP015K in plasma: CL/F		Up to Day 12
Secondary	PK parameter of ASP015K in plasma: Cmax		Up to Day 12
Secondary	PK parameter of ASP015K in plasma: Ctrough	Ctrough: Concentration immediately prior to dosing at multiple dosing	Up to Day 12
Secondary	PK parameter of ASP015K in plasma: PTR	PTR: Peak trough ratio	Up to Day 12
Secondary	PK parameter of ASP015K in plasma: Rac	Rac: accumulation ratio	Up to Day 12
Secondary	PK parameter of ASP015K in plasma: t1/2		Up to Day 12
Secondary	PK parameter of ASP015K in plasma: tmax		Up to Day 12
Secondary	PK parameter of ASP015K in plasma: Vz/F		Up to Day 12
Secondary	PK parameter of metabolites of ASP015K in plasma: AUCinf		Up to Day 12
Secondary	PK parameter of metabolites of ASP015K in plasma: AUClast		Up to Day 12
Secondary	PK parameter of metabolites of ASP015K in plasma: AUCtau		Up to Day 12
Secondary	PK parameter of metabolites of ASP015K in plasma: Cmax		Up to Day 12
Secondary	PK parameter of metabolites of ASP015K in plasma: Ctrough		Up to Day 12
Secondary	PK parameter of metabolites of ASP015K in plasma: PTR		Up to Day 12
Secondary	PK parameter of metabolites of ASP015K in plasma: Rac		Up to Day 12
Secondary	PK parameter of metabolites of ASP015K in plasma: t1/2		Up to Day 12
Secondary	PK parameter of metabolites of ASP015K in plasma: tmax		Up to Day 12
Secondary	Safety assessed by Adverse events		Up to 17 days after first study drug dosing
Secondary	Number of participants with abnormal vital signs and/or adverse events related to treatment		Up to 17 days after first study drug dosing
Secondary	Number of participants with abnormal laboratory values and/or adverse events related to treatment		Up to 17 days after first study drug dosing
Secondary	Number of participants with abnormal standard 12-lead ECG and/or adverse events related to treatment	ECG: Electrocardiogram	Up to 17 days after first study drug dosing