Pharmacokinetics of IV Formulation

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

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

Study Overview

• Status: Withdrawn
• Conditions: Invasive Aspergillosis
• Intervention / Treatment: Drug: F901318

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.

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects will be males or females of any ethnic origin between 18 and 55 years or age and weighing between 50 and 100kg.
2. Females of child bearing potential must be established on a reliable form of contraception and have a negative pregnancy test at screening and Day -1
3. Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (hepatic transaminases must be within normal limits, 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. Female and male subjects who are not, or whose partners are not willing to use appropriate contraception with two reliable forms of contraception or who are not otherwise unable to conceive children (hysterectomy, oophorectomy, tubal ligation or post menopausal).
2. 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
3. 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 and paracetamol) unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IV drug; AUC0-t of single intravenous dose of F901318	Drug: F901318; Evaluation of AUC0-t

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic profile (AUC0-t)	AUC0-t	120 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability (Adverse events)	Adverse events	120 hours

Collaborators and Investigators

• Sponsor: F2G Biotech GmbH
• Collaborators: Quotient Clinical
• Investigators: Principal Investigator: Litza McKenzie, MD, Quotient Clinical

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2017
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: March 6, 2017
• First Submitted That Met QC Criteria: March 9, 2017
• First Posted (Actual): March 10, 2017

Study Record Updates

• Last Update Posted (Actual): November 1, 2017
• Last Update Submitted That Met QC Criteria: October 30, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Aspergillosis; Anti-Infective Agents; Antifungal Agents; Olorofim
• Other Study ID Numbers: F901318-01-10-17; QCL117986 (Other Identifier: Quotient Clinical)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No