Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects

Invasive Aspergillosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03340597
• Other study ID #: F901318-01-13-17
• Status: Completed
• Phase: Phase 1
• Start date: December 12, 2017
• Est. completion date: April 13, 2018

Study information

• Verified date: July 2018
• Source: F2G Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 13, 2018
• Est. primary completion date: April 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aspergillosis
• Invasive Aspergillosis

Intervention

Drug:
• F901318
F901318 tablet

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit	Leeds	West Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
F2G Ltd.	Covance

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment emergent adverse events	safety and tolerability	18 days
Secondary	Area under the curve (AUC) 0-tau for F901318	Pharmacokinetics (PK) of oral doses of F90318	11 days
Secondary	maximum plasma concentration (Cmax) for F901318	PK of oral doses of F90318	11 days
Secondary	minimum plasma concentration (Cmin) for F901318	PK of oral doses of F90318	11 days