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Completed

NCT Number: NCT02128321

A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Repaglinide and Caffeine

The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of Repaglinide and possible metabolites after single dose administration. In addition, this study will assess the effect of multiple doses of isavuconazole on the pharmacokinetics of caffeine and possible metabolites after single dose administration. Safety and tolerability of isavuconazole alone and in combination with Repaglinide or in combination with caffeine will be assessed.

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Key information

Conditions

Pharmacokinetics of Repaglinide Healthy Subjects Pharmacokinetics of Caffeine

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel Early Phase Clinical Unit

Baltimore, Maryland, 21225, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

Isavuconazole

Drug

oral

Other names: BAL4815

repaglinide

Drug

oral

Other names: Prandin®

Caffeine

Drug

oral

Primary outcomes

  1. Pharmacokinetics of plasma repaglinide and possible metabolite concentration: Area under the concentration-time curve from time of dosing to the last quantifiable concentration (AUClast)

    Time frame: Days 1 and 14

  2. Pharmacokinetics of plasma repaglinide and possible metabolite concentration: Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf)

    Time frame: Days 1 and 14

  3. Pharmacokinetics of plasma repaglinide and possible metabolite concentration: Maximum concentration (Cmax)

    Time frame: Days 1 and 14

  4. Pharmacokinetics of caffeine and possible metabolite concentration: Area under the concentration-time curve from time of dosing to the last quantifiable concentration (AUClast)

    Time frame: Days 3 and 16

  5. Pharmacokinetics of caffeine and possible metabolite concentration: Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf)

    Time frame: Days 3 and 16

  6. Pharmacokinetics of caffeine and possible metabolite concentration: Maximum concentration (Cmax)

    Time frame: Days 3 and 16

  7. Pharmacokinetics of plasma isavuconazole concentration: Trough concentration (Ctrough)

    Time frame: Days 10-18

  8. Pharmacokinetics of plasma isavuconazole concentration: Area under the concentration-time curve during the time interval between consecutive dosing (AUCtau)

    Time frame: Days 13, 14 and 16

  9. Pharmacokinetics of plasma isavuconazole concentration: Maximum concentration (Cmax)

    Time frame: Days 13, 14 and 16

  10. Pharmacokinetics of plasma isavuconazole concentration: Time after dosing when Cmax occurs (tmax)

    Time frame: Days 13, 14 and 16

  11. Safety assessed through adverse events

    Time frame: up to Day 24

  12. Safety assessed through clinical laboratory evaluations

    Time frame: up to Day 18

    Laboratory assessments will include hematology, serum chemistry and urinalysis parameters

  13. Safety assessed by 12-lead electrocardiograms (ECGs)

    Time frame: up to Day 18

  14. Safety assessed through vital signs

    Time frame: up to Day 18

    Vital signs will be measured including oral temperature, pulse, and sitting blood pressure

Sponsors and collaborators

Lead sponsor

Astellas Pharma Global Development, Inc.

Industry

Collaborators

  • Basilea Pharmaceutica International Ltd

Registry information

Official study title

A Phase 1 Open Label Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Repaglinide and Caffeine

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 1, 2014
Registry last updated
May 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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