Status:
COMPLETED
Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects
Lead Sponsor:
F2G Biotech GmbH
Collaborating Sponsors:
Covance
Conditions:
Invasive Aspergillosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ...
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, tolerabi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2018
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03340597
Start Date
December 12 2017
End Date
April 13 2018
Last Update
August 2 2018
Active Locations (1)
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1
Covance Clinical Research Unit
Leeds, West Yorkshire, United Kingdom