Bioequivalence Evaluation of a New and Current Tablet of ASP015K

NCT02531191 | Completed Phase 1

• 1 other identifier: 015K-CL-PK27
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the bioequivalence of a new tablet versus a current tablet of ASP015K under fasting conditions after single oral administration in healthy male subjects.

Conditions

Healthy Volunteers

Keywords

ASP015K; bioequivalence study; JAK inhibitor

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK) parameter of ASP015K: Area under the concentration-time curve (AUC) from the time of dosing to the time of the last sampling (AUCt)

  Up to 72 hours after each study drug dosing

• Pharmacokinetics (PK) parameter of ASP015K: Maximum concentration (Cmax)

  Up to 72 hours after each study drug dosing

Secondary Outcomes (12)

• Safety assessed by Adverse Events (AEs)

  Up to 6 days after the study drug dosing of Period 2

• Safety assessed by Vital signs

  Up to 6 days after the study drug dosing of Period 2

• Safety assessed by Laboratory tests

  Up to 6 days after the study drug dosing of Period 2

• Safety assessed by 12-lead ECGs

  Up to 6 days after the study drug dosing of Period 2

• Pharmacokinetics (PK) profile of ASP015K: AUCinf

  Up to 72 hours after each study drug dosing

Study Arms (2)

New Tablet Preceding Group

EXPERIMENTAL

Each subject received an ASP015K small tablet in period 1 and an ASP015K current tablet in period 2 under fasted conditions with 200 mL of water.

Drug: peficitinib

Current Tablet Preceding Group

EXPERIMENTAL

Each subject received an ASP015K current tablet in period 1 and an ASP015K small tablet in period 2 under fasted conditions with 200 mL of water.

Drug: peficitinib

Interventions

peficitinib DRUG

oral

Also known as: ASP015K

Current Tablet Preceding Group; New Tablet Preceding Group

Eligibility Criteria

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

You may qualify if:

• kg ≤ body weight at screening \< 80.0 kg
• ≤ BMI at screening \< 26.4 \[BMI = Body weight (kg) / (Body height (m))2\]
• Subjects who agree to use the following highly effective contraception consisting of two forms of birth control (at least one of which must be a barrier method) starting at written informed consent through 90 days after the study drug administration in Period 2.
• Subjects who agree not to donate sperm starting at informed consent through 90 days after the study drug administration in Period 2.
• Subjects judged as healthy by investigator or sub-investigator based on physical examinations (subjective symptoms and objective findings) and all clinical tests obtained at screening and from check-in to immediately before the study drug administration in Period 1.

You may not qualify if:

• Subjects who have received investigational drugs within 120 days prior to screening or who plan to receive investigational drugs from screening assessment to check-in in Period 1 (Day -1).
• Any blood donation or blood drawing apply the following:
• Whole blood collection (≥ 400 mL): from 90 days prior to screening to check-in in Period 1 (Day -1)
• Whole blood collection (≥ 200 mL): from 30 days prior to screening to check-in in Period 1 (Day -1)
• Platelet or plasma donation: from 30 days prior to screening to check-in in Period 1 (Day -1)
• Subjects who had used or plan to use any prescribed or non-prescribed drugs within 7 days prior to check-in in Period 1 (Day -1).
• Any deviation of blood pressure, pulse, body temperature, or 12-lead ECG at screening or check-in in Period 1 (Day -1) from the following normal range:
• Supine pressure: Systolic: ≥ 90 mmHg, ≤ 140 mmHg; Diastolic: ≥ 40 mmHg, ≤ 90 mmHg
• Supine pulse: ≥ 40 bpm, ≤ 99 bpm
• Axillary temperature: ≥ 35.0 ºC, ≤ 37.0 ºC
• lead ECG: Normal or clinically irrelevant abnormality QTc interval: ≥ 330 msec, \< 430 msec
• Any deviation of laboratory tests at Screening or on Day -1 (check-in) in Period 1 from the following normal range. Normal range of each test at the test or assay site will be used.
• Hematology: \> 20% of upper limit or \< 20% of lower limit.
• Chemistry: deviation of ALT, AST, Cre, blood electrolytes (Na, K, Cl), or fasting blood glucose. \> 20% of upper limit or \< 20% of lower limit in other than above tests; however no lower limit is set with respect to ALT, AST, γ-GTP, T-Bil, ALP, LDH, CK, T-Cho, TG, Cre, and UA.
• Urinalysis (qualitative): deviation in any of the urinalysis.

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

Related Publications (2)

• 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

• Shibata M, Toyoshima J, Kaneko Y, Oda K, Kiyota T, Kambayashi A, Nishimura T. The Bioequivalence of Two Peficitinib Formulations, and the Effect of Food on the Pharmacokinetics of Peficitinib: Two-Way Crossover Studies of a Single Dose of 150 mg Peficitinib in Healthy Volunteers. Clin Pharmacol Drug Dev. 2021 Mar;10(3):283-290. doi: 10.1002/cpdd.843. Epub 2020 Jul 3.

  PMID: 32618438 DERIVED

MeSH Terms

Interventions

peficitinib

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 24, 2015
• Study Start: June 21, 2015
• Primary Completion: July 15, 2015
• Study Completion: July 15, 2015
• Last Updated: October 16, 2024

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)