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Trial record 22 of 51 for:    "Invasive Aspergillosis" | "Anti-Infective Agents"

Study of Potential for Interaction of Fluconazole With F901318

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ClinicalTrials.gov Identifier: NCT02730442
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : February 2, 2017
Sponsor:
Collaborator:
Celerion Ltd
Information provided by (Responsible Party):
F2G Ltd.

Brief Summary:

This will be an open label study in two parts. In the first part, F901318 (dose 2 mg/kg IV over 4 hours, Day 1) will be followed by F901318 (2 mg/kg IV over 4 hours) given on Day 8, after dosing with fluconazole 800 mg daily for 1 day (Day 4) and 400 mg daily orally for 4 days (Days 5 to 8). Up to twenty subjects will be included in two cohorts which will undergo the same dosing schedules of fluconazole and F901318 and undergo the same procedures. The first cohort will consist of 12 subjects studied in two groups of six subjects each. If there is clearly a difference in F901318 kinetics detectable before and after dosing with fluconazole in this first cohort, the second cohort will not be studied. If there is no clear difference, the second cohort will also be studied to give a final result. In this cohort, based on the pharmacokinetic findings in cohort 1, the dose of F901318 may be increased to up to 4 mg/kg to establish a dose suitable for phase 2 evaluation. PK sampling for plasma F901318 will continue from before the first dose up to and including 72 hours after dosing. PK sampling for fluconazole will continue from before the first dose and up to 72 hours after the fifth dose. A follow up visit will be conducted 7 +/- 2 days after discharge from the clinical unit following completion of blood sampling following the second dose of F901318 and the fifth dose of fluconazole.

The second part of the study will take place if no appreciable change in the pharmacokinetics of either F901318 or fluconazole has been observed in either the first or the second cohorts in the first part of the study. This second part will enrol 12 subjects. These subjects will receive fluconazole 800 mg daily for one day (Day 1) and 400 mg daily orally for 4 days (Days 2 to 5) in combination with F901318 which will be given in a dose of up to 4 mg/kg IV bid for one day (Day 1) followed by 7 doses of intravenous F901318 up to 2.5 mg/kg bid (Days 2 to 5). Pharmacokinetic profiles of F901318 and fluconazole will be obtained during dosing and over a 72-hour period following the final dose of both compounds.


Condition or disease Intervention/treatment Phase
Invasive Aspergillosis Drug: F901318 Drug: Fluconazole Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study in Healthy Volunteers to Evaluate the Potential for Drug/Drug Interactions Between F901318 and Fluconazole
Actual Study Start Date : February 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis
Drug Information available for: Fluconazole

Arm Intervention/treatment
Experimental: Single dose F901318 with fluconazole
AUC0-t for F901318 will be assessed before and after 5 days of treatment with fluconazole oral
Drug: F901318
Administration of F901318 intravenously
Other Name: Antifungal agent

Drug: Fluconazole
Oral administration
Other Name: Antifungal agent




Primary Outcome Measures :
  1. Treatment emergent adverse events [ Time Frame: 5 days ]
    Adverse events


Secondary Outcome Measures :
  1. Pharmacokinetics area under concentration/time curve 0-t [ Time Frame: 5 days ]
    Area under concentration time curve 0-t



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects will be males and females of any ethnic origin aged between 18 and 45 years of age and weighing 50-100 kg inclusive.
  2. Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is acceptable).
  3. Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.

Exclusion Criteria:

  1. Male and female subjects who are not willing to use appropriate contraception during the study and for three months thereafter.
  2. Subjects who have received any prescribed systemic or topical medication within 14 days of the dose administration unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety.
  3. Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the dose administration (with the exception of vitamin/mineral supplements and paracetamol) unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety.
  4. Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the dose administration unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety. For at least 2 weeks prior to dosing and until all blood samples and observations are completed on Day 18 +/- 2 (Part 1) or Day 15 +/- 2 (Part 2), subjects will not be allowed to eat any food or drink any beverage containing alcohol, grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family e.g. kale, broccoli, watercress, spring greens, kohlrabi, Brussels sprouts, mustard and charbroiled meats.

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): NCT02730442


Locations
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United Kingdom
CELERION
Belfast, Northern Ireland, United Kingdom, BT9 6AD
Sponsors and Collaborators
F2G Ltd.
Celerion Ltd
Investigators
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Principal Investigator: A Stewart Celerion Ltd

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Responsible Party: F2G Ltd.
ClinicalTrials.gov Identifier: NCT02730442     History of Changes
Other Study ID Numbers: F01318-01-05-15
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Anti-Infective Agents
Aspergillosis
Mycoses
Fluconazole
Antifungal Agents
Miconazole
Olorofim
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP3A Inhibitors