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Pharmacokinetics of IV Formulation

Primary Purpose

Invasive Aspergillosis

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

F901318

About this trial

This is an interventional treatment trial for Invasive Aspergillosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects will be males or females of any ethnic origin between 18 and 55 years or age and weighing between 50 and 100kg.
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
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)
Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions

Exclusion Criteria:

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).
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
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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IV drug

Arm Description

AUC0-t of single intravenous dose of F901318

Outcomes

Primary Outcome Measures

Pharmacokinetic profile (AUC0-t)

AUC0-t

Secondary Outcome Measures

Tolerability (Adverse events)

Adverse events

Full Information

NCT ID

NCT03076905

First Posted

March 6, 2017

Last Updated

October 30, 2017

Sponsor

F2G Biotech GmbH

Collaborators

Quotient Clinical

1. Study Identification

Unique Protocol Identification Number

NCT03076905

Brief Title

Pharmacokinetics of IV Formulation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Withdrawn

Why Stopped

study no longer required in current format

Study Start Date

May 2017 (Anticipated)

Primary Completion Date

July 2017 (Anticipated)

Study Completion Date

August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

F2G Biotech GmbH

Collaborators

Quotient Clinical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Invasive Aspergillosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Assessment of IV pharmacokinetics

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IV drug

Arm Type

Experimental

Arm Description

AUC0-t of single intravenous dose of F901318

Intervention Type

Drug

Intervention Name(s)

F901318

Intervention Description

Evaluation of AUC0-t

Primary Outcome Measure Information:

Title

Pharmacokinetic profile (AUC0-t)

Description

AUC0-t

Time Frame

120 hours

Secondary Outcome Measure Information:

Title

Tolerability (Adverse events)

Description

Adverse events

Time Frame

120 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects will be males or females of any ethnic origin between 18 and 55 years or age and weighing between 50 and 100kg. 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 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) Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions Exclusion Criteria: 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). 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Litza McKenzie, MD

Organizational Affiliation

Quotient Clinical

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pharmacokinetics of IV Formulation

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