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Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03340597
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : February 15, 2018
Sponsor:
Collaborator:
Covance
Information provided by (Responsible Party):
F2G Ltd.

Brief Summary:
A Phase I, open label study evaluating safety, tolerability and pharmacokinetics of F901318 in healthy subjects following up to 28 days dosing, where F901318 is given orally . The effect of food upon the pharmacokinetics of F901318 and the effect of F901318 upon the pharmacokinetics of midazolam will also be assessed.

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

Detailed Description:
Each cohort will comprise 12 healthy subjects and cohorts A1 (A2), B1 and B2 will be conducted in a sequential manner such that the dose level can be optimised upon review of emerging safety, tolerability and PK data.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase I, Open Label Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of Varying Oral Dosing Regimens for F901318
Actual Study Start Date : December 12, 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Arm Intervention/treatment
Experimental: A1; F901318 (10 days)
F901318 : 10 days dose 1 orally
Drug: F901318
F901318 tablet

Experimental: A2; F901318 (optional cohort)
F901318 : 10 days dosing orally, alternative dosing regimen if required
Drug: F901318
F901318 tablet

Experimental: B1; F901318 (28 days)
F901318: 28 days dose 1 orally
Drug: F901318
F901318 tablet

Experimental: B2: F901318 (28 days) & midazolam
F901318: 28 days alternative regimen orally and midazolam (2 mg oral):
Drug: F901318
F901318 tablet

Drug: Midazolam
Midazolam oral solution

Experimental: C: F901318 (single dose fed/fasted)
randomised 2-way crossover (oral dose)
Drug: F901318
F901318 tablet




Primary Outcome Measures :
  1. Incidence of treatment emergent adverse events [ Time Frame: 38 days ]
    safety and tolerability


Secondary Outcome Measures :
  1. Area under the curve (AUC) 0-tau for F901318 [ Time Frame: 29 days ]
    Pharmacokinetics (PK) of oral doses of F90318

  2. maximum plasma concentration (Cmax) for F901318 [ Time Frame: 29 days ]
    PK of oral doses of F90318

  3. minimum plasma concentration (Cmin) for F901318 [ Time Frame: 29 days ]
    PK of oral doses of F90318

  4. Area under the curve (AUC) 0-infinity for midazolam [ Time Frame: 1 day ]
    PK of single oral dose of midazolam (with and without F901318)

  5. maximum plasma concentration (Cmax) for midazolam [ Time Frame: 1 day ]
    PK of single oral dose of midazolam (with and without F901318)



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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:

  • Subjects will be males or females of any ethnic origin between 18 and 55 years of age, weighing between 60 and 100 kg, with a body mass index (BMI) between 18 and 30 kg/m2.
  • 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 not acceptable)
  • Male subjects and female subjects of childbearing potential must agree to use appropriate contraception from screening, during the study and for 3 months after the last dose of study drug

Exclusion Criteria:

  • Female subjects who are pregnant or lactating.
  • Subjects who have received any prescribed systemic or topical medication (other than hormonal contraception or hormone replacement therapy) 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.
  • 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) unless in the opinion of the Investigator and the medical monitor the medication will not interfere with the study procedures or compromise safety.
  • 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.

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): NCT03340597


Contacts
Contact: Karen Cornelissen, PhD +44 (0)7900 220371 kcornelissen@f2g.com

Locations
United Kingdom
Covance Clinical Research Unit Recruiting
Leeds, West Yorkshire, United Kingdom
Sponsors and Collaborators
F2G Ltd.
Covance
Investigators
Principal Investigator: Jim Bush, MB ChB PhD MRCS FFPM Covance CRU Ltd

Responsible Party: F2G Ltd.
ClinicalTrials.gov Identifier: NCT03340597     History of Changes
Other Study ID Numbers: F901318-01-13-17
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Aspergillosis
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action