Drug Interaction Study of Isavuconazole and Midazolam

NCT01406171 | Completed Phase 1

• 1 other identifier: 9766-CL-0023
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pharmacokinetics of Isavuconazole; Pharmacokinetics of Midazolam; Healthy Volunteers

Keywords

Isavuconazole; ASP9766; BAL8557; Midazolam; Healthy volunteers

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic assessment of AUC through the analysis of blood samples

  Up to Day 13

• Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood samples

  Up to Day 13

Study Arms (1)

Isavuconazole and Midazolam

EXPERIMENTAL

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; Drug: Midazolam

Interventions

Isavuconazole DRUG

oral

Also known as: ASP9766, BAL8557

Isavuconazole and Midazolam

Midazolam DRUG

Oral

Isavuconazole and Midazolam

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Basilea Pharmaceutica: collaborator

Study Sites (1)

Covance Clinical Research

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

isavuconazole; Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Medical Director

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: August 1, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 1, 2011

Record last verified: 2011-07

Locations

US (1)