Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2015-02-28
2016-09-30
Brief Summary
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Detailed Description
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This first part (Part 1) will test doses already evaluated in the previous single ascending dose study (F901318-01-01-14, 0.25-4 mg/kg given over 4 hours). The dose levels for the study are expected to be 1.5, 3 and 4 mg/kg/day given as a four hour infusion once daily.
In the second part of the study (Part 2), doses higher than those previously evaluated may be studied and/or different dosing schedules designed to deliver a maximum tolerated dose over 24 hours. If a dose level higher than those previously studied is chosen, there will be an optional single dose studied initially for safety and pharmacokinetic profile (Part 2A), followed about 14 days later in another group of subjects by exposure at that same dose level over 8 consecutive days (Part 2B). These higher doses may be given in a once or twice daily dosing schedule. Six subjects will receive active compound and two will receive placebo in both the single dose and multiple dose cohorts. The single dose cohorts will receive study drug in a sentinel group design in which two subjects receive study drug (one active and one placebo) on the first day and the rest of the group one day later. There will be a review of safety data by the Principal Investigator and the Medical Monitor after the first two subjects have been dosed and before the last six subjects are dosed in each cohort in part 2A.
In Part 2, up to forty-eight subjects will complete the study in up to 6 cohorts (Part 2A, Groups D1 to F1, single day dosing, and Part 2B, Groups D2 to F2 eight days' dosing). Subjects in Parts 1 and 2B will be on the study for approximately 7 weeks and Part 2A for approximately 8 weeks. Each subject will participate in one treatment cohort only, residing at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 6 (120 hours after the single dose in Parts 1 and 2A) and from Day -1 (the day before dosing) to Day 13 (120 hours after the first dose in Part 2B). The proposed total daily dose levels for Part 2 will be up to 10 mg/kg/day given either once daily or in two split daily doses. The duration of the infusions will be between 2 and 24 hours which may include a loading dose to achieve therapeutic plasma concentrations as quickly as possible.
All subjects will return for a post-study visit 8 to 10 days after the last dose of study medication.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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A active
Six subjects receiving F901318 1.5 mg/kg intravenously for eight days
F901318
Administration of active compound
A placebo
Two subjects receiving F901318 placebo intravenously for eight days
Placebo
Administration of placebo
B active
Six subjects receiving F901318 3 mg/kg intravenously for eight days
F901318
Administration of active compound
B placebo
Two subjects receiving F901318 placebo intravenously for eight days
Placebo
Administration of placebo
C active
Six subjects receiving F901318 4 mg/kg intravenously for eight days
F901318
Administration of active compound
C placebo
Two subjects receiving F901318 placebo intravenously for eight days
Placebo
Administration of placebo
D1 active
Six subjects dosed for one day with F901318 intravenously dose to be determined
F901318
Administration of active compound
D1 placebo
Two subjects receiving F901318 placebo intravenously for one day
Placebo
Administration of placebo
E1 active
Six subjects dosed for one day with F901318 intravenously dose to be determined
F901318
Administration of active compound
E1 placebo
Two subjects receiving F901318 placebo intravenously for one day
Placebo
Administration of placebo
F1 active
Six subjects dosed for one day with F901318 intravenously dose to be determined
F901318
Administration of active compound
F1 placebo
Two subjects receiving F901318 placebo intravenously for one day
Placebo
Administration of placebo
D2 active
Six subjects dosed for eight days with F901318 intravenously dose to be determined
F901318
Administration of active compound
D2 placebo
Two subjects receiving F901318 placebo intravenously for eight days
Placebo
Administration of placebo
E2 active
Six subjects dosed for eight days with F901318 intravenously dose to be determined
F901318
Administration of active compound
E2 placebo
Two subjects receiving F901318 placebo intravenously for eight days
Placebo
Administration of placebo
F2 active
Six subjects dosed for eight days with F901318 intravenously dose to be determined
F901318
Administration of active compound
F2 placebo
Two subjects receiving F901318 placebo intravenously for eight days
Placebo
Administration of placebo
Interventions
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F901318
Administration of active compound
Placebo
Administration of placebo
Eligibility Criteria
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Inclusion Criteria
2. 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)
3. Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
4. Subjects must have ophthalmology assessments within the normal limits at screening. This includes normal Meibomian gland function
Exclusion Criteria
2. 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
3. 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
4. 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
5. 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.
18 Years
45 Years
MALE
Yes
Sponsors
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Hammersmith Medicines Research
OTHER
F2G Biotech GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Frans van den Berg, MB ChB
Role: PRINCIPAL_INVESTIGATOR
Hammersmith Medicines Research
Locations
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Hammersmith Medicines Research
London, UK, United Kingdom
Countries
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Other Identifiers
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F901318-01-02-14
Identifier Type: -
Identifier Source: org_study_id
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