Drug Interaction Study of Isavuconazole and Midazolam

This study has been completed.
Sponsor:
Collaborator:
Basilea Pharmaceutica
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01406171
First received: July 6, 2011
Last updated: July 28, 2011
Last verified: July 2011
  Purpose

The purpose of this study is to determine the effect of isavuconazole at steady state on the pharmacokinetics of midazolam in healthy adult subjects.


Condition Intervention Phase
Pharmacokinetics of Isavuconazole
Pharmacokinetics of Midazolam
Healthy Volunteers
Drug: Isavuconazole
Drug: Midazolam
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase 1, Open-Label, Drug Interaction Study of the Pharmacokinetics of Isavuconazole 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 assessment of AUC through the analysis of blood samples [ Time Frame: Up to Day 13 ] [ Designated as safety issue: No ]
  • Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood samples [ Time Frame: Up to Day 13 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: May 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Isavuconazole and Midazolam
Isavuconazole three times per day (TID) for 2 days followed by once a day (QD) for 9 days. Midazolam single doses on days 1 and 12
Drug: Isavuconazole
oral
Other Names:
  • ASP9766
  • BAL8557
Drug: Midazolam
Oral

Detailed Description:

Subjects will check-in on Day -1 and remain confined to the study center until the completion of study procedures on Day 14. Subjects will return to the study center for an outpatient follow-up visit on Day 21. Blood and urine samples will be taken at various times during the study.

Subjects will receive a single dose of oral midazolam syrup on Day 1. On Days 3 and 4, isavuconazole will be dosed orally three times daily (TID). On Days 5 through 13, isavuconazole will be dosed orally once daily (QD). A single dose of oral midazolam syrup will be administered on Day 12.

  Eligibility

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

Inclusion Criteria:

  • The subject agrees to sexual abstinence, is surgically sterile, is postmenopausal, or is using a medically acceptable method to prevent pregnancy during the study period
  • The subject must weigh at least 45 kg and have a body mass index (BMI) of 18-32 kg/m2
  • The subject's has a normal 12-lead electrocardiogram (ECG)
  • The subject is a non-smoker and has not used tobacco or nicotine products for a minimum of 6 months
  • The subject's clinical laboratory test results are within normal limits

Exclusion Criteria:

  • The subject has a previous history of any clinically significant gastro-intestinal, neurological, renal, hepatic, pulmonary, metabolic, cardio-vascular, psychiatric, endocrine, hematological disorder or disease, malignancy excluding non-melanoma skin cancer
  • The subject has a known or suspected hypersensitivity to midazolam, isavuconazole, or the azole class of compounds
  • The subject has a history of consuming more than 14 units of alcoholic beverages per week, has a history of drug or alcohol abuse within the past 2 years, or has a positive screen for alcohol or drugs of abuse/illegal drugs (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits)
  • The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to study drug administration, or over-the-counter medication within 1 week prior to study drug administration, with the exception of acetaminophen up to 2g/day
  • The subject anticipates an inability to abstain from caffeine or alcohol use for 48 hours prior to clinic admission and throughout the duration of the study
  • The subject anticipates an inability to abstain from grapefruit, Seville oranges, star fruit, or any products containing these items from 72 hours prior to clinic admission and throughout the duration of the study
  • The subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic admission
  • The subject has a positive test for hepatitis C antibody or hepatitis B surface antigen or a known history of human immunodeficiency virus
  • The subject has been vaccinated within 30 days prior to study drug administration
  • The subject has received an experimental agent within 30 days or five half-lives, whichever is longer, prior to study drug administration
  • The 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 admission
  • The subject has any other condition which precludes the subject's participation in the trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406171

Locations
United States, Wisconsin
Covance Clinical Research
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Astellas Pharma Inc
Basilea Pharmaceutica
Investigators
Study Director: Medical Director Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier: NCT01406171     History of Changes
Other Study ID Numbers: 9766-CL-0023
Study First Received: July 6, 2011
Last Updated: July 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Isavuconazole
ASP9766
BAL8557
Midazolam
Healthy volunteers

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

ClinicalTrials.gov processed this record on April 20, 2014