Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects
Primary Purpose
Invasive Aspergillosis
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
F901318
Sponsored by
About this trial
This is an interventional other trial for Invasive Aspergillosis
Eligibility 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.
Sites / Locations
- Covance Clinical Research Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
A1; F901318 (10 days)
A2; F901318
A3; F901318
A4; F901318
Arm Description
F901318 : 10 days dosing orally
F901318 : 10 days dosing orally, alternative dosing regimen
F901318 : 10 days dosing orally, alternative dosing regimen
F901318 : 10 days dosing orally, alternative dosing regimen
Outcomes
Primary Outcome Measures
Incidence of treatment emergent adverse events
safety and tolerability
Secondary Outcome Measures
Area under the curve (AUC) 0-tau for F901318
Pharmacokinetics (PK) of oral doses of F90318
maximum plasma concentration (Cmax) for F901318
PK of oral doses of F90318
minimum plasma concentration (Cmin) for F901318
PK of oral doses of F90318
Full Information
NCT ID
NCT03340597
First Posted
November 9, 2017
Last Updated
July 31, 2018
Sponsor
F2G Biotech GmbH
Collaborators
Covance
1. Study Identification
Unique Protocol Identification Number
NCT03340597
Brief Title
Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
December 12, 2017 (Actual)
Primary Completion Date
April 13, 2018 (Actual)
Study Completion Date
April 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
F2G Biotech GmbH
Collaborators
Covance
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Aspergillosis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A1; F901318 (10 days)
Arm Type
Experimental
Arm Description
F901318 : 10 days dosing orally
Arm Title
A2; F901318
Arm Type
Experimental
Arm Description
F901318 : 10 days dosing orally, alternative dosing regimen
Arm Title
A3; F901318
Arm Type
Experimental
Arm Description
F901318 : 10 days dosing orally, alternative dosing regimen
Arm Title
A4; F901318
Arm Type
Experimental
Arm Description
F901318 : 10 days dosing orally, alternative dosing regimen
Intervention Type
Drug
Intervention Name(s)
F901318
Intervention Description
F901318 tablet
Primary Outcome Measure Information:
Title
Incidence of treatment emergent adverse events
Description
safety and tolerability
Time Frame
18 days
Secondary Outcome Measure Information:
Title
Area under the curve (AUC) 0-tau for F901318
Description
Pharmacokinetics (PK) of oral doses of F90318
Time Frame
11 days
Title
maximum plasma concentration (Cmax) for F901318
Description
PK of oral doses of F90318
Time Frame
11 days
Title
minimum plasma concentration (Cmin) for F901318
Description
PK of oral doses of F90318
Time Frame
11 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Bush, MB ChB PhD MRCS FFPM
Organizational Affiliation
Covance CRU Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
Covance Clinical Research Unit
City
Leeds
State/Province
West Yorkshire
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects
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