Evaluate F901318 Treatment of Invasive Fungal Infections in Patients Lacking Treatment Options

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

A study to evaluate F901318 (study drug) for the treatment of invasive fungal infections in patients lacking suitable alternative treatment options.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: F2G Biotech GmbH; F2G Ltd.
• Collaborators: IQVIA; Iqvia Pty Ltd
• Treatments: Olorofim

Criteria

Inclusion Criteria:

• Male and female aged at least 18 years, or male and female aged 16 years or 17 years and who weigh at least 40 kg whom have given informed consent

• Ability and willingness to comply with the protocol.

• Able to take oral medication

• Female must be non-lactating and at no risk of pregnancy

• Male with female partners of childbearing potential must either abstain from sexual intercourse or use a highly effective means of contraception

• Patients with invasive fungal disease

• Patients who have limited alternative treatment options

Exclusion Criteria:

• Women who are pregnant or breastfeeding.

• Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug.

• Patients with chronic aspergillosis, aspergilloma or allergic bronchopulmonary aspergillosis.

• HIV infection but not currently receiving antiretroviral therapy.

• Patients with a medical condition that may jeopardize adherence to the protocol or may cause unacceptable additional risk to the patient

• Previously enrolled patients or patients enrolled in any clinical trial within the last 30 days

• Patients receiving treatment limited to supportive care due to predicted short survival time.

• Prohibited concomitant medications.

• Any exclusion criteria required by local regulatory authorities.