Pharmacokinetics of IV Formulation

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

NCT03076905•F2G Biotech GmbH

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

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

Key Dates

Start Date

May 1, 2017

Primary Completion Date

July 1, 2017

Completion Date

August 1, 2017

Last Updated

November 1, 2017

Conditions

Invasive Aspergillosis

Interventions

F901318

DRUG

Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants

NCT03717623

PosaconazolePharmacokinetics+5 more

View study

RECRUITING

Role of Antifungal Prophylaxis in Elderly Patients With Acute Myeloid Leukemia During Consolidation Therapy

NCT06382922

Invasive Aspergillosis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 1, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pharmacokinetics of IV Formulation

Inclusion Criteria

Exclusion Criteria

Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants

Role of Antifungal Prophylaxis in Elderly Patients With Acute Myeloid Leukemia During Consolidation Therapy

European Study of Cerebral Aspergillosis Treated With Isavuconazole

Diagnostic Performance of an Aspergillus-specific Nested PCR Assay in Cerebrospinal Fluid Samples

Diagnosing Pulmonary Aspergillosis in Patients With Hematological Malignancies: A Multicentre Prospective Evaluation of an Aspergillus PCR Assay and a Galactomannan ELISA in Bronchoalveolar Lavage Samples

VL-2397 Compared to Standard First-Line Treatment for Invasive Aspergillosis (IA) in Adults