Drug-Drug Interaction Study Evaluating Effects of ASP015K on Rosuvastatin

NCT01959399 | Completed Phase 1

• 1 other identifier: 015K-CL-PK26
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study will be to assess the effect of multiple-doses of ASP015K on the pharmacokinetics of rosuvastatin in healthy adult male and female subjects.

Conditions

Healthy Subjects; Pharmacokinetics of ASP015K

Keywords

ASP015K; healthy subjects

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic (PK) parameter for rosuvastatin: AUClast

  Area under the curve to the last measurable time

  Days 1 and 10

• Pharmacokinetic parameter for rosuvastatin: AUCinf

  Area under the curve to the infinity

  Days 1 and 10

• Pharmacokinetic parameter for rosuvastatin: Cmax

  Maximum Concentration

  Days 1 and 10

Secondary Outcomes (6)

• Composite of pharmacokinetic parameters for rosuvastatin: time after dosing when Cmax occurs (tmax), apparent-terminal elimination half-life (t1/2), apparent volume of distribution (Vz/F), apparent plasma clearance (CL/F)

  Days 1 and 10

• Composite of PK parameters for ASP015K: Area under the curve in the dosing interval (AUCtau), Maximum Concentration (Cmax), time after dosing when Cmax occurs (tmax), apparent volume of distribution (Vz/F), apparent plasma clearance at steady (CLss/F)

  Days 9 and 10

• Pharmacokinetic parameter for ASP015K: Ctrough

  Days 7-10

• Pharmacokinetic parameter for ASP015K metabolites: Ctrough

  Days 7-10

• Composite of pharmacokinetic parameters for ASP015K metabolites: Area under the curve in the dosing interval (AUCtau), Maximum Concentration (Cmax), time after dosing when Cmax occurs (tmax)

  Days 9 and 10

Study Arms (1)

ASP015K + rosuvastatin

EXPERIMENTAL

Drug: ASP015K; Drug: Rosuvastatin

Interventions

ASP015K DRUG

oral tablet

ASP015K + rosuvastatin

Rosuvastatin DRUG

oral tablet

ASP015K + rosuvastatin

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 at screening.
• Asian subject must be first generation Japanese born in Japan with both parents and four grandparents of Japanese descent and have resided outside of Japan for 5 years or less, or first generation Chinese born in China with both parents and four grandparents of Chinese descent and have resided outside of China for 5 years or less, or first generation Korean born in Korea with both parents and four grandparents of Korean descent and have resided outside of Korea for 5 years or less.
• Non-Asian subject is self-reported as White, Black or African American, and Hispanic or Latino.
• Female subject must be of non-childbearing potential (i.e., post-menopausal \[defined as at least 1 year without menses\] prior to screening or documented surgically sterile or status post hysterectomy \[at least 1 month prior to screening\]).
• Female subject must have a negative pregnancy test at screening and day -1.
• Female subject must not donate ova starting at screening and throughout the study period, and for 90 days after the final study drug administration.
• Male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at screening and continue throughout the study period and for 90 days after final study drug administration.
• Male subject must not donate sperm from screening and throughout the study period and for 90 days after final study drug administration.
• Subject agrees not to participate in another investigational study while on treatment.
• Subject must be capable of swallowing multiple tablets.

You may not qualify if:

• Female subject who has been pregnant within 6 months before screening assessment or breast feeding within 3 months before screening.
• Subject has a known or suspected hypersensitivity to rosuvastatin, ASP015K, or any components of the formulations used.
• Subject has had a previous intolerance or adverse reaction to a statin therapy.
• 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, gastro intestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy, as judged by the Investigator or designee.
• Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to day -1.
• Subject has a mean pulse \< 40 or \> 90 beats per minute (bpm); mean systolic blood pressure (SBP) \> 140 mmHg; mean diastolic blood pressure (DBP) \> 90 mmHg (measurements taken in triplicate after subject has been resting in sitting position for at least 5 minutes at screening and day -1.
• Subject has used any prescribed or non-prescribed 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 (to a maximum of 2 g/day).
• Subject has smoked or has used tobacco-containing products and nicotine or nicotine containing products in the past 6 months prior to screening.
• 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 at screening or day -1.
• Subject has used any inducer of liver metabolism (e.g. barbiturates, rifampin) in the 3 months prior to day -1.
• Subject has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic check-in on day -1.
• Subject has a positive serology test for hepatitis B surface antigen (HBsAg) (total), anti hepatitis A virus (Ig M), anti-hepatitis C virus, anti-hepatitis B core, or anti HIV type 1 or type 2 at screening.
• Subject has participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half-lives of the drug, whichever is longer, prior to screening.

Sponsors & Collaborators

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

Study Sites (1)

PAREXEL - Early Phase Unit

Glendale, California, 91206, United States

Location

Related Publications (1)

• Zhu T, Parker B, Wojtkowski T, Nishimura T, Garg JP, Han D, Fisniku O, Keirns J. Drug Interactions Between Peficitinib, an Orally Administered, Once-Daily Janus Kinase Inhibitor, and Rosuvastatin in Healthy Subjects. Clin Pharmacokinet. 2017 Jul;56(7):747-757. doi: 10.1007/s40262-016-0474-4.

  PMID: 27878567 DERIVED

MeSH Terms

Interventions

peficitinib; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Medical Director

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 10, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 10, 2013

Record last verified: 2013-10

Locations

US (1)