A Study to Assess Drug Interaction of ASP015K and Midazolam

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01182077
First received: August 11, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted

August 11, 2010
August 11, 2010
June 2010
July 2010   (final data collection date for primary outcome measure)
Pharmacokinetic variables assessed through the analysis of blood and urine samples [ Time Frame: Days 1-8 and Days 21-27 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study to Assess Drug Interaction of ASP015K and Midazolam
A Phase 1, Open Label, Crossover, Drug Interaction Study of the Pharmacokinetics of ASP015K and Midazolam After Separate and Concomitant Administration to Healthy Adult Subjects

The objective of the study is to characterize the effect of multiple doses of ASP015K on the pharmacokinetics of a single dose of midazolam.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
  • Healthy
  • Pharmacokinetics of ASP015K and Midazolam
  • Drug: ASP015K
    Oral
  • Drug: Midazolam
    Oral
  • Experimental: Group 1
    ASP015K low dose and midazolam followed by ASP015K high dose and midazolam
    Interventions:
    • Drug: ASP015K
    • Drug: Midazolam
  • Experimental: Group 2
    ASP015K high dose and midazolam followed by ASP015K low dose and midazolam
    Interventions:
    • Drug: ASP015K
    • Drug: Midazolam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject weighing at least 45kg and BMI of 18-32 kg/m2, inclusive
  • If female, subject is at least 2 years post menopausal or is surgically sterile per documentation provided by a third party medical professional and the subject is not pregnant as documented by a negative serum pregnancy test
  • If male, subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy during the study period

Exclusion Criteria:

  • History of any clinically significant disorder, disease or malignancy excluding non-melanoma skin cancer
  • Recent history (within 6 months) of drug or alcohol abuse or positive urine screen for drugs of abuse/illegal drugs
  • Treatment with prescription drugs or complementary and alternative medicines (CAM) within 14 days prior to study drug administration, or over the counter medication within 1 week prior to study drug administration
  • A symptomatic, viral, bacterial or fungal infection within 1 week prior to clinic check-in
  • Positive test for hepatitis C antibody, or positive test for hepatitis B surface antigen (HBsAg)
  • History of the human immunodeficiency virus (HIV) antibody
  • Positive tuberculosis (TB) skin test or Quantiferon Gold test
  • Vaccinated within the last 30 days prior to study drug administration
  • Received an experimental agent within 30 days or five half-lives, whichever is longer, prior to study drug administration
  • 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 admission
  • Absolute neutrophil count (ANC) <2500 cells/mm3
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01182077
015K-CL-PK05
No
Sr Manager Clinical Trials Registry, Astellas Pharma Global Development
Astellas Pharma Inc
Not Provided
Study Director: Use Central Contact Astellas Pharma Global Development
Astellas Pharma Inc
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP