Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects

NCT03340597 | Completed Phase 1

• 1 other identifier: F901318-01-13-17
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Invasive Aspergillosis

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment emergent adverse events

  safety and tolerability

  18 days

Secondary Outcomes (3)

• Area under the curve (AUC) 0-tau for F901318

  11 days

• maximum plasma concentration (Cmax) for F901318

  11 days

• minimum plasma concentration (Cmin) for F901318

  11 days

Study Arms (4)

A1; F901318 (10 days)

EXPERIMENTAL

F901318 : 10 days dosing orally

Drug: F901318

A2; F901318

EXPERIMENTAL

F901318 : 10 days dosing orally, alternative dosing regimen

Drug: F901318

A3; F901318

EXPERIMENTAL

F901318 : 10 days dosing orally, alternative dosing regimen

Drug: F901318

A4; F901318

EXPERIMENTAL

F901318 : 10 days dosing orally, alternative dosing regimen

Drug: F901318

Interventions

F901318 DRUG

F901318 tablet

A1; F901318 (10 days); A2; F901318; A3; F901318; A4; F901318

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• F2G Biotech GmbH: lead
• Covance: collaborator

Study Sites (1)

Covance Clinical Research Unit

Leeds, West Yorkshire, United Kingdom

Location

MeSH Terms

Interventions

olorofim

Study Officials

• Jim Bush, MB ChB PhD MRCS FFPM

  Covance CRU Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 13, 2017
• Study Start: December 12, 2017
• Primary Completion: April 13, 2018
• Study Completion: April 13, 2018
• Last Updated: August 2, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)