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

NCT02760342 | Completed Phase 1

• 1 other identifier: 015K-CL-PK20
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects

Keywords

Pharmacokinetics; Metformin; Drug-drug interaction; ASP015K

Outcome Measures

Primary Outcomes (3)

• 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

• PK parameter of metformin in plasma: Cmax

  Cmax: Maximum concentration

  Up to Day 12

• 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 Outcomes (31)

• PK parameter of metformin in plasma: CL/F

  Up to Day 12

• PK parameter of metformin in plasma: t1/2

  Up to Day 12

• PK parameter of metformin in plasma: tmax

  Up to Day 12

• PK parameter of metformin in plasma: Vz/F

  Up to Day 12

• PK parameter of metformin in urine: Aelast

  Up to Day 12

Study Arms (1)

ASP015K and Metformin

EXPERIMENTAL

Subjects will receive a single oral dose of metformin on Days 1 and 10, a single dose of ASP015K on Day 3 and multiple doses of ASP015K once daily Day 5 to Day 11. Subjects will receive a single dose of metformin and ASP015K concurrently on Day 10.

Drug: peficitinib; Drug: Metformin

Interventions

peficitinib DRUG

Oral

Also known as: ASP015K

ASP015K and Metformin

Metformin DRUG

Oral

ASP015K and Metformin

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Site JP00001

Kagoshima, Japan

Location

Related Publications (1)

• Toyoshima J, Shibata M, Kaibara A, Kaneko Y, Izutsu H, Nishimura T. Population pharmacokinetic analysis of peficitinib in patients with rheumatoid arthritis. Br J Clin Pharmacol. 2021 Apr;87(4):2014-2022. doi: 10.1111/bcp.14605. Epub 2020 Dec 1.

  PMID: 33068028 DERIVED

MeSH Terms

Interventions

peficitinib; Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2016
• First Posted: May 3, 2016
• Study Start: May 15, 2016
• Primary Completion: June 26, 2016
• Study Completion: June 26, 2016
• Last Updated: October 16, 2024

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)