A Study to Evaluate the Effect of Verapamil on the Pharmacokinetics of ASP015K in Healthy Adult Subjects

NCT02111317 | Completed Phase 1

• 1 other identifier: 015K-CL-PK04
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of verapamil, a P-glycoprotein (P-gp) inhibitor, on the pharmacokinetics of ASP015K. This study will also assess the safety and tolerability of ASP015K administered alone and also and in combination with verapamil.

Conditions

Healthy Subjects; Pharmacokinetics of ASP015K

Keywords

ASP015K; Pharmacokinetics; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics of ASP015K: Maximum concentration (Cmax)

  Days 1-4 and Days 12-15

• Pharmacokinetics of ASP015K: Area under the concentration-time curve (AUC) from time of dosing to the last quantifiable concentration (AUClast)

  Days 1-4 and Days 12-15

• Pharmacokinetics of ASP015K: AUC from the time of dosing extrapolated to time infinity (AUCinf)

  Days 1-4 and Days 12-15

Secondary Outcomes (2)

• Pharmacokinetic profile of ASP015K: time of maximum plasma concentration (tmax), terminal elimination half-life (t½), apparent total systemic clearance (CL/F), and apparent volume of distribution during the terminal elimination phase (Vz/F)

  Days 1-4 and Days 12-15

• Pharmacokinetic profile of ASP015K metabolites: Cmax, AUClast, AUCinf, tmax and t½

  Days 1-4 and Days 12-15

Study Arms (1)

ASP015K and verapamil

EXPERIMENTAL

Single dose of ASP015K, then repeat dose of verapamil, then a second single dose of ASP015K while continuing verapamil

Drug: ASP015K; Drug: verapamil

Interventions

ASP015K DRUG

oral

ASP015K and verapamil

verapamil DRUG

oral

Also known as: CALAN®

ASP015K and verapamil

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject has a Body Mass Index (BMI) range of 18.5-32.0 kg/m2, inclusive, and must weigh at least 50 kg
• Subject must be capable of swallowing multiple tablets
• Subject agrees not to participate in another investigational study while on treatment

You may not qualify if:

• Subject has a known or suspected hypersensitivity to verapamil, ASP015K, or any components of the formulations used.
• Subject has any of the liver function tests above the upper limit of normal (ULN)
• Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
• Subject has any history or evidence of any clinically significant cardiovascular, GI, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy
• Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory) infection, or fungal (noncutaneous) infection within 1 week prior to day -1.
• Subject has any clinically significant abnormality following physical examination, ECG, such as sick sinus syndrome, second- or third-degree atrioventricular block, or atrial flutter/atrial fibrillation, or clinical laboratory tests
• Subject has a mean pulse \< 50 or \> 90 beats per minute (bpm); mean systolic blood pressure (SBP) \< 100 or \> 140 mmHg; mean diastolic blood pressure (DBP) \< 60 or \> 90 mmHg (measurements taken in triplicate after subject has been resting in sitting position for 5 minutes)
• Subject has a mean QTcF interval of \> 430 msec (for males) and \> 450 msec (for females)
• Subject has used any prescribed or nonprescribed drugs (including vitamins, natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to study drug administration, with the exception of hormone replacement therapy (HRT) and intermittent acetaminophen (no more than 2 g per day)
• Subject has smoked or has used tobacco-containing products and nicotine or nicotine-containing products in the past 6 months
• Subject has a history of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical substance abuse within past 2 years prior to screening (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits)
• Subject has a positive test for alcohol, drugs of abuse, or cotinine
• Subject anticipates an inability to abstain from xanthine (e.g., caffeine), grapefruit, Seville oranges (including marmalade), star fruit, or any products containing these items from 72 hours prior to day -1 and throughout the duration of the study
• Subject has used any inducer of metabolism (e.g., barbiturates, rifampin) in the past 3 months prior to day -1
• Subject has had any significant blood loss, donated 1 unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within past 7 days

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead
• Janssen Biotech, Inc.: collaborator

Study Sites (1)

PAREXEL

Glendale, California, 91206, United States

Location

MeSH Terms

Interventions

peficitinib; Verapamil

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Global Clinical Pharmacology Lead

  Astellas Pharma Global Development, Inc.

  STUDY CHAIR

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: April 4, 2014
• First Posted: April 11, 2014
• Study Start: October 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 11, 2014

Record last verified: 2014-04

Locations

US (1)