F901318 Single Ascending Dose Study in Healthy Male Volunteers
Condition: Invasive Aspergillosis
MeSH terms: Aspergillosis
Intervention: F901318; Placebo
Intervention description: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile; Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities
Intervention MeSH terms: Olorofim
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: First in man; Antifungal; Intravenous infusion; Healthy volunteers

Summary:

      F901318 is a potent new antifungal agent for the treatment of systemic fungal infections.
      This study will test it for the first time in man with the objective of assessing its safety,
      tolerability and pharmacokinetic profile.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects will be males of any ethnic origin between 18 and 45 years of age and
             weighing 60-90 kg inclusive

          2. 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 acceptable)

          3. Subjects will have given their written informed consent to participate in the study
             and to abide by the study restrictions

        Exclusion Criteria:

          1. Male subjects who are not, or whose partners are not willing to use appropriate
             contraception (such as a condom) with established use of oral, injected or implanted
             hormonal contraceptive, intrauterine device or diaphragm with spermicide for three
             months after the last dose

          2. Subjects who have received any prescribed systemic or topical medication within 14
             days of dosing with study drug unless in the opinion of the Investigator and the
             Medical Monitor the medication will not interfere with the study procedures or
             compromise safety

          3. Subjects who have used any non-prescribed systemic or topical medication (including
             herbal remedies) within 7 days of dosing with study drug (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

          4. Subjects who have received any medications, including St John's Wort, known to
             chronically alter drug absorption or elimination processes within 30 days of dosing
             with study drug unless in the opinion of the Investigator and the Medical Monitor the
             medication will not interfere with the study procedures or compromise safety

          5. Subjects who are still participating in a clinical study (e.g. attending follow-up
             visits) or who have participated in a clinical study involving administration of an
             investigational drug (new chemical or biological entity) in the past 3 months