NCT03076905

Pharmacokinetics of IV Formulation

F901318 - A Phase I, Single Intravenous Dose, Safety, Tolerability and Pharmacokinetics Study in Healthy Male and Female Subjects

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: F2G Biotech GmbH · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Open label evaluation of a single intravenous dose of F901318 to healthy male and female subjects with pharmacokinetic and safety and tolerability evaluation.

Detailed description

Open label single intravenous dose, single group study. Eight subjects (ideally 4 male and 4 female, minimum of two females) will be studied. The drug product will be a F901318 solution for infusion (6mg/mL). The dose will be 4 mg/kg delivered in the fasted state (8 hours minimum) by intravenous infusion over 2 hours. Each subject will be on study for approximately 6 weeks. Each subject will reside at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 4 (72 hours post-dose). Blood samples for pharmacokinetic evaluation will be obtained up to and including 120 hours post dose. Safety and tolerability will also be assessed. Subjects will return to the clinical unit at 96 and 120 hours for pharmacokinetic blood sampling. All subjects will return for a post-study visit 8 to 10 days after the dose of study medication.

Conditions

• Invasive Aspergillosis

Interventions

Type	Name	Description
DRUG	F901318	Evaluation of AUC0-t

Timeline

• Start date: 2017-05-01
• Primary completion: 2017-07-01
• Completion: 2017-08-01
• First posted: 2017-03-10
• Last updated: 2017-11-01