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Healthy SubjectsPhase 1NCT01959399

Drug-Drug Interaction Study Evaluating Effects of ASP015K on Rosuvastatin

A Phase 1 study testing ASP015K and Rosuvastatin in people with Healthy Subjects and Pharmacokinetics of ASP015K, run by Astellas Pharma Global Development, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects, Pharmacokinetics of ASP015K
What is being tested?
ASP015K and Rosuvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
May 2013to Jul 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • PAREXEL - Early Phase Unit

    Glendale, California, 91206

Other trials in United States

About this study

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

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.

Being tested
ASP015K, Rosuvastatin
Keywords
ASP015K, healthy subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01959399
Study groupRoleWhat they receive
ASP015K + rosuvastatinExperimentalNot described
Receives: Drug: ASP015K; Drug: Rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetic (PK) parameter for rosuvastatin: AUClast

    Area under the curve to the last measurable time

    Measured: Days 1 and 10

  2. Pharmacokinetic parameter for rosuvastatin: AUCinf

    Area under the curve to the infinity

    Measured: Days 1 and 10

  3. Pharmacokinetic parameter for rosuvastatin: Cmax

    Maximum Concentration

    Measured: Days 1 and 10

Secondary outcomes (6)

  1. 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)

    Measured: Days 1 and 10

  2. 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)

    Measured: Days 9 and 10

  3. Pharmacokinetic parameter for ASP015K: Ctrough

    Plasma concentration immediately before the next administration of study drug

    Measured: Days 7-10

  4. Pharmacokinetic parameter for ASP015K metabolites: Ctrough

    Plasma concentration immediately before the next administration of study drug

    Measured: Days 7-10

  5. 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)

    Measured: Days 9 and 10

  6. Safety assessed adverse events, clinical laboratory evaluations, 12-lead ECG measurements, physical examination and vital sign measurements

    Measured: Day 1-14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionJul 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01959399
Sponsor's protocol ID
015K-CL-PK26
Status last verified
Oct 2013
First submitted
8 Oct 2013
Last updated
10 Oct 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27878567

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASP015K and Rosuvastatin in people with Healthy Subjects and Pharmacokinetics of ASP015K, run by Astellas Pharma Global Development, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic (PK) parameter for rosuvastatin: AUClast (time frame: Days 1 and 10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01959399, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2013.

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