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Pharmacokinetics of RepaglinidePhase 1NCT02128321

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

A Phase 1 study testing Isavuconazole, Repaglinide and Caffeine in people with Pharmacokinetics of Repaglinide and Pharmacokinetics of Caffeine, run by Astellas Pharma Global Development, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
What is being tested?
Isavuconazole, Repaglinide and Caffeine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
Jan 2014to Feb 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Parexel Early Phase Clinical Unit

    Baltimore, Maryland, 21225

Other trials in United States

About this study

Official title: A Phase 1 Open Label 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.

Being tested
Isavuconazole, Repaglinide, Caffeine
Keywords
Isavuconazole, Repaglinide, Caffeine, BAL4815, BAL8728, Healthy Subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IsavuconazoleDrug

    Also called BAL4815

    oral

  • RepaglinideDrug

    Also called Prandin®

    oral

  • CaffeineDrug

    oral

Study groups in NCT02128321
Study groupRoleWhat they receive
Isavuconazole + Repaglinide + CaffeineExperimentalIsavuconazole three times a day on Days 5 and 6 and once a day on Days 7 through 17, repaglinide on Days 1 and Day 14, caffeine on Days 3 and 16
Receives: Drug: Isavuconazole; Drug: Repaglinide; Drug: Caffeine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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)

    Measured: Days 1 and 14

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

    Measured: 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)

    Measured: 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)

    Measured: Days 3 and 16

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

    Measured: Days 3 and 16

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

    Measured: Days 10-18

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

    Measured: Days 13, 14 and 16

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

    Measured: Days 13, 14 and 16

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

    Measured: Days 13, 14 and 16

  11. Safety assessed through adverse events

    Measured: up to Day 24

  12. Safety assessed through clinical laboratory evaluations

    Laboratory assessments will include hematology, serum chemistry and urinalysis parameters

    Measured: up to Day 18

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

    Measured: up to Day 18

  14. Safety assessed through vital signs

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

    Measured: up to Day 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02128321
Sponsor's protocol ID
9766-CL-0053
Status last verified
Apr 2014
First submitted
29 Apr 2014
Last updated
1 May 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Isavuconazole, Repaglinide and Caffeine in people with Pharmacokinetics of Repaglinide and Pharmacokinetics of Caffeine, run by Astellas Pharma Global Development, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02128321.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2014.

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