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Pharmacokinetics of IV Formulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03076905
Recruitment Status : Withdrawn (study no longer required in current format)
First Posted : March 10, 2017
Last Update Posted : November 1, 2017
Quotient Clinical
Information provided by (Responsible Party):
F2G Ltd.

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

Condition or disease Intervention/treatment Phase
Invasive Aspergillosis Drug: F901318 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Assessment of IV pharmacokinetics
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: F901318 - A Phase I, Single Intravenous Dose, Safety, Tolerability and Pharmacokinetics Study in Healthy Male and Female Subjects
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Arm Intervention/treatment
Experimental: IV drug
AUC0-t of single intravenous dose of F901318
Drug: F901318
Evaluation of AUC0-t

Primary Outcome Measures :
  1. Pharmacokinetic profile (AUC0-t) [ Time Frame: 120 hours ]

Secondary Outcome Measures :
  1. Tolerability (Adverse events) [ Time Frame: 120 hours ]
    Adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03076905

Sponsors and Collaborators
F2G Ltd.
Quotient Clinical
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Principal Investigator: Litza McKenzie, MD Quotient Clinical

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Responsible Party: F2G Ltd. Identifier: NCT03076905    
Other Study ID Numbers: F901318-01-10-17
QCL117986 ( Other Identifier: Quotient Clinical )
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Antifungal Agents
Anti-Infective Agents