NCT02342574

Brief Summary

Double blind, placebo controlled, parallel group ascending dose study evaluating single and multiple (x8 days) dose levels of F901318 in groups of male healthy subjects with the objective of defining a dosing schedule for phase ll clinical trials. F901318, a novel and potent antifungal agent for the treatment of invasive aspergillosis, will be delivered intravenously in a range of dosing schedules driven by pharmacokinetic evaluation in real time. Safety and tolerability of those schedules will also be assessed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 19, 2016

Status Verified

August 1, 2016

Enrollment Period

1.6 years

First QC Date

January 15, 2015

Last Update Submit

September 16, 2016

Conditions

Invasive Aspergillosis

Outcome Measures

Primary Outcomes (1)

  • safety: adverse events

    adverse events

    13 days

Secondary Outcomes (2)

  • pharmacokinetics AUC

    13 days

  • pharmacokinetics Cmin

    13 days

Study Arms (18)

A active

EXPERIMENTAL

Six subjects receiving F901318 1.5 mg/kg intravenously for eight days

Drug: F901318

A placebo

PLACEBO COMPARATOR

Two subjects receiving F901318 placebo intravenously for eight days

Drug: Placebo

B active

EXPERIMENTAL

Six subjects receiving F901318 3 mg/kg intravenously for eight days

Drug: F901318

B placebo

PLACEBO COMPARATOR

Two subjects receiving F901318 placebo intravenously for eight days

Drug: Placebo

C active

EXPERIMENTAL

Six subjects receiving F901318 4 mg/kg intravenously for eight days

Drug: F901318

C placebo

PLACEBO COMPARATOR

Two subjects receiving F901318 placebo intravenously for eight days

Drug: Placebo

D1 active

EXPERIMENTAL

Six subjects dosed for one day with F901318 intravenously dose to be determined

Drug: F901318

D1 placebo

PLACEBO COMPARATOR

Two subjects receiving F901318 placebo intravenously for one day

Drug: Placebo

E1 active

EXPERIMENTAL

Six subjects dosed for one day with F901318 intravenously dose to be determined

Drug: F901318

E1 placebo

PLACEBO COMPARATOR

Two subjects receiving F901318 placebo intravenously for one day

Drug: Placebo

F1 active

EXPERIMENTAL

Six subjects dosed for one day with F901318 intravenously dose to be determined

Drug: F901318

F1 placebo

PLACEBO COMPARATOR

Two subjects receiving F901318 placebo intravenously for one day

Drug: Placebo

D2 active

EXPERIMENTAL

Six subjects dosed for eight days with F901318 intravenously dose to be determined

Drug: F901318

D2 placebo

PLACEBO COMPARATOR

Two subjects receiving F901318 placebo intravenously for eight days

Drug: Placebo

E2 active

EXPERIMENTAL

Six subjects dosed for eight days with F901318 intravenously dose to be determined

Drug: F901318

E2 placebo

PLACEBO COMPARATOR

Two subjects receiving F901318 placebo intravenously for eight days

Drug: Placebo

F2 active

EXPERIMENTAL

Six subjects dosed for eight days with F901318 intravenously dose to be determined

Drug: F901318

F2 placebo

PLACEBO COMPARATOR

Two subjects receiving F901318 placebo intravenously for eight days

Drug: Placebo

Interventions

F901318DRUG

Administration of active compound

A activeB activeC activeD1 activeD2 activeE1 activeE2 activeF1 activeF2 active
PlaceboDRUG

Administration of placebo

A placeboB placeboC placeboD1 placeboD2 placeboE1 placeboE2 placeboF1 placeboF2 placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects will be males of any ethnic origin between 18 and 45 years of age and weighing 60-100 kg inclusive
  • Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (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
  • Subjects must have ophthalmology assessments within the normal limits at screening. This includes normal Meibomian gland function

You may not qualify if:

  • Male subjects who are not willing to use appropriate contraception (such as a condom) during the study and until follow up
  • Subjects who have received any prescribed systemic or topical medication within 14 days of dosing with study drug 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 dosing with study drug (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
  • Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of dosing with study drug 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 are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical or biological entity) in the past 3 months since the last dose.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammersmith Medicines Research

London, UK, NW10 7EW, United Kingdom

Location

MeSH Terms

Interventions

olorofim

Study Officials

  • Frans van den Berg, MB ChB

    Hammersmith Medicines Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2015

First Posted

January 21, 2015

Study Start

February 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 19, 2016

Record last verified: 2016-08

Locations

GB(1)