Evaluation of Immediate Release Tablet

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Single dose comparison of liquid and solid formulation, followed by study of effect of high fat breakfast.

Evaluation of multiple dose pharmacokinetics and tolerability

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: F2G Biotech GmbH; F2G Ltd.
• Collaborator: Quotient Clinical
• Treatments: Olorofim

Criteria

Inclusion Criteria:

1. Subjects will be healthy males or females of any ethnic origin between 18 and 55 years of age and weighing between 50-100 kg (body mass index of 18.0-32.0 kg/m2 inclusive).

2. Females of child bearing potential must be established on a reliable form of contraception and have a negative pregnancy test at screening.

3. 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).

4. Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.

Exclusion Criteria:

1. Subjects who do not have suitable veins for multiple vene-punctures/cannulation as assessed by the investigator at screening

2. Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator

3. Male or female subjects who are not willing to use appropriate contraception during the study and until 3 months after the last dose.

4. Subjects who have received any prescribed systemic or topical medication 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.