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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02760342
Other study ID # 015K-CL-PK20
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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