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A Study to Evaluate the Effect of Multiple Doses of Esomeprazole on the Pharmacokinetics of Isavuconazole | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Phase 1 Randomized Open Label, Parallel Group Study to Evaluate the Effect of Multiple Doses of Esomeprazole on the Pharmacokinetics of Isavuconazole

NCT02128893•Astellas Pharma Global Development, Inc.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

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
+5 more criteria

Locations (1)

Parexel Early Phase Clinical Unit

Baltimore, Maryland, United States

Key Dates

Start Date

January 1, 2014

Primary Completion Date

February 1, 2014

Completion Date

February 1, 2014

Last Updated

May 1, 2014

Enrollment

ACTUAL participants

Conditions

Pharmacokinetics of IsavuconazoleHealthy Subjects

Interventions

Isavuconazole

DRUG

Esomeprazole

DRUG

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Healthy ParticipantsHealthy Subjects+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 1, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

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