A Study to Assess Drug Interaction of ASP015K and Midazolam

This study has been completed.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
First received: August 11, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
The objective of the study is to characterize the effect of multiple doses of ASP015K on the pharmacokinetics of a single dose of midazolam.

Condition Intervention Phase
Pharmacokinetics of ASP015K and Midazolam
Drug: ASP015K
Drug: Midazolam
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: June 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
ASP015K low dose and midazolam followed by ASP015K high dose and midazolam
Drug: ASP015K
Drug: Midazolam
Experimental: Group 2
ASP015K high dose and midazolam followed by ASP015K low dose and midazolam
Drug: ASP015K
Drug: Midazolam


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01182077

United States, Florida
Miami, Florida, United States, 33014
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Use Central Contact Astellas Pharma Global Development
  More Information

Responsible Party: Sr Manager Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier: NCT01182077     History of Changes
Other Study ID Numbers: 015K-CL-PK05 
Study First Received: August 11, 2010
Last Updated: August 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
healthy volunteers

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on May 02, 2016