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A Study to Evaluate the Effect of Multiple Doses of Esomeprazole on the Pharmacokinetics of Isavuconazole

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ClinicalTrials.gov Identifier: NCT02128893
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : May 1, 2014
Sponsor:
Collaborator:
Basilea Pharmaceutica International Ltd
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Brief Summary:
The purpose of this study is to assess the effect of multiple doses of esomeprazole on the pharmacokinetics of isavuconazole. In addition, safety and tolerability of isavuconazole alone and in combination with esomeprazole will be assessed

Condition or disease Intervention/treatment Phase
Pharmacokinetics of Isavuconazole Healthy Subjects Drug: Isavuconazole Drug: Esomeprazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1 Randomized Open Label, Parallel Group Study to Evaluate the Effect of Multiple Doses of Esomeprazole on the Pharmacokinetics of Isavuconazole
Study Start Date : January 2014
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Isavuconazole alone
Isavuconazole three times a day on Days 1 and 2 and once a day on Days 3, 4, and 5
Drug: Isavuconazole
oral
Other Name: BAL4815

Experimental: Isavuconazole and Esomeprazole
Esomeprazole daily for 10 days starting on Day 1 and isavuconazole three times a day on Days 6 and 7 and once a day on Days 8, 9, and 10
Drug: Isavuconazole
oral
Other Name: BAL4815

Drug: Esomeprazole
oral
Other Name: Nexium®




Primary Outcome Measures :
  1. Pharmacokinetics of plasma isavuconazole concentration: Area under the concentration-time curve during the time interval between consecutive dosing (AUCtau) [ Time Frame: Day 5 (Arm 1) and Day 10 (Arm 2) ]
  2. Pharmacokinetics of plasma isavuconazole concentration: Maximum concentration (Cmax) [ Time Frame: Day 5 (Arm 1) and Day 10 (Arm 2) ]
  3. Pharmacokinetics of plasma isavuconazole concentration: Time after dosing when Cmax occurs (tmax) [ Time Frame: Day 5 (Arm 1) and Day 10 (Arm 2) ]
  4. Safety assessed through adverse events [ Time Frame: up to Day 17 ]
  5. Safety assessed through clinical laboratory evaluations [ Time Frame: up to Day 11 ]
    Laboratory assessments will include hematology, serum chemistry and urinalysis parameters

  6. Safety assessed by 12-lead electrocardiograms (ECGs) [ Time Frame: up to Day 11 ]
  7. Safety assessed through vital signs [ Time Frame: up to Day 11 ]
    Vital signs will be measured including oral temperature, pulse, and sitting blood pressure



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The subject has a body weight of at least 50 kg and a body mass index of 18.5 to 32 kg/m2, inclusive
  • The subject's 12-lead electrocardiogram (ECG) is normal
  • The subject's clinical laboratory test results are within normal limits

Exclusion Criteria:

  • The subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy
  • The subject has a history of bowel obstruction, swallowing disorder, severe gastro-intestinal disorders, major gastrointestinal surgery, gastric/duodenal ulcers or any other condition that may interfere with study drug absorption
  • Female subject has been pregnant within 6 months before screening or breast feeding within 3 months before screening
  • The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of either Short or Long QT syndrome (suggested by sudden death of a close relative at a young age due to possible or probable cardiac causes). QT is the time between the start of the Q wave and the end of the T wave in the heart's electrical system
  • The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic admission
  • The subject has received a vaccination within the last 30 days prior to study drug administration
  • The subject has a positive serology test for Hepatitis B surface antigen (HBsAg), Hepatitis A Immunoglobulin M antibody (anti HAV (IgM)), Hepatitis C antibody (anti-HCV), or human immunodeficiency virus (anti-HIV 1+2)
  • The subject has a known or suspected allergy to any of the components of the trial products or the azole class of compounds, or a history of multiple and/or severe allergies to drugs or foods, or a history of severe anaphylactic reactions
  • The subject has used tobacco or nicotine containing products in the last 6 months
  • The subject has had treatment with any prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g. St. John's wort) in the 2 weeks prior with the exception of hormonal methods of contraception, hormone replacement therapy, or occasional use of acetaminophen up to 2 g/day
  • The subject has participated in any interventional clinical study or has received any investigational drugs within past 30 days or 5 half-lives, whichever is longer
  • 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 anticipates an inability to abstain from alcohol or caffeine use for 48 hours prior and throughout the duration of the study; or from grapefruit, grapefruit juice, star fruit, or Seville oranges or any products containing these items from 72 hours prior and throughout the duration of the study
  • The subject has 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/hard liquor) or the subject tests positive for alcohol or drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates)
  • The subject has taken part in strenuous exercise within 3 days before Day 1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128893


Locations
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United States, Maryland
Parexel Early Phase Clinical Unit
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Basilea Pharmaceutica International Ltd
Investigators
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Study Director: Senior Medical Director Astellas Pharma Global Development, Inc.

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Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT02128893     History of Changes
Other Study ID Numbers: 9766-CL-0054
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: May 1, 2014
Last Verified: April 2014

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
Isavuconazole
Esomeprazole
BAL4815
BAL8728
Healthy Subjects

Additional relevant MeSH terms:
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Isavuconazole
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents