Drug-Drug Interaction Study Evaluating Effects of ASP015K on Rosuvastatin

Healthy Subjects Clinical Trial

Official title:

A Phase 1, Open-Label, Single-Sequence Drug Interaction Study to Evaluate the Effect of Multiple-Dose ASP015K on the Pharmacokinetics of Rosuvastatin in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959399
• Other study ID #: 015K-CL-PK26
• Status: Completed
• Phase: Phase 1
• First received: October 8, 2013
• Last updated: October 8, 2013
• Start date: May 2013
• Est. completion date: July 2013

Study information

• Verified date: October 2013
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• Subject has a positive tuberculosis (TB) skin test, Quantiferon Gold test or T-SPOT® test at screening.

• Subject has received any vaccine within 60 days prior to study drug administration.

• Subject has had major gastrointestinal surgery or has a medical condition which may inhibit the absorption and/or metabolism of study drug.

• Subject anticipates an inability to abstain from xanthine (e.g., caffeine), grapefruit, Seville blood 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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Subjects
• Pharmacokinetics of ASP015K

Intervention

Drug:
• ASP015K
oral tablet
• Rosuvastatin
oral tablet

Locations

Country	Name	City	State
United States	PAREXEL - Early Phase Unit	Glendale	California

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Global Development, Inc.	Janssen Biotech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic (PK) parameter for rosuvastatin: AUClast	Area under the curve to the last measurable time	Days 1 and 10	No
Primary	Pharmacokinetic parameter for rosuvastatin: AUCinf	Area under the curve to the infinity	Days 1 and 10	No
Primary	Pharmacokinetic parameter for rosuvastatin: Cmax	Maximum Concentration	Days 1 and 10	No
Secondary	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	No
Secondary	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	No
Secondary	Pharmacokinetic parameter for ASP015K: Ctrough	Plasma concentration immediately before the next administration of study drug	Days 7-10	No
Secondary	Pharmacokinetic parameter for ASP015K metabolites: Ctrough	Plasma concentration immediately before the next administration of study drug	Days 7-10	No
Secondary	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	No
Secondary	Safety assessed adverse events, clinical laboratory evaluations, 12-lead ECG measurements, physical examination and vital sign measurements		Day 1-14	No