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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000823-25 | EudraCT Number |
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| Name | Class |
|---|---|
| Simbec Research | INDUSTRY |
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F901318 is a potent new antifungal agent for the treatment of systemic fungal infections. This study will test it for the first time in man with the objective of assessing its safety, tolerability and pharmacokinetic profile.
Double blind, placebo controlled, ascending single intravenous dose, sequential group study. Forty subjects will be studied in 5 cohorts (Groups A to E), each group consisting of 8 subjects. Each subject will be on study for approximately 6 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 post-dose). Each cohort will be dosed in a leading edge design in which two subjects will receive study drug (1 active and 1 placebo) on the first dosing day, and the last 6 will receive study drug (active or placebo) on the second dosing day.
All subjects will return for a post-study visit 8 to 10 days after the dose of study medication.
Cohorts will be dosed at 2 weekly intervals. There will be a review of safety and pharmacokinetic data prior to each dose escalation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F901318 0.25 mg/kg | Experimental | Single intravenous infusion over 4 hours |
|
| 0.25 mg/kg placebo | Placebo Comparator | Single intravenous infusion over 4 hours |
|
| F901318 0.75 mg/kg | Experimental | Single intravenous infusion over 4 hours |
|
| Placebo 0.75 mg/kg | Placebo Comparator | Single intravenous infusion over 4 hours |
|
| F901318 1.5 mg/kg | Experimental | Single intravenous infusion over 4 hours |
|
| Placebo 1.5 mg/kg | Placebo Comparator | Single intravenous infusion over 4 hours |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F901318 | Drug | Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Events | Adverse events will be collected from the time of screening until the final study visit | Single dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Significant Clinical Safety Labs and ECG Abnormalities | Number of subjects with significant Clinical safety labs and ECG abnormalities as judged by the investigator from screening until final study visit | Single dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | Blood samples (6 mL) for analysis of F901318 plasma concentration will be drawn pre-dose and at 1h, 2h, 3h and 4h and then 4.25, 4.5, 5.0, 5.5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours following the start of the infusion. (20 samples). | Single dose |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salvatore Febbraro, MD | Simbec Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simbec Research | Merthyr Tydfil | Mid Glamorgan | CF48 4DR | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | F901318 0.25 mg/kg | Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile |
| FG001 | 0.25 mg/kg Placebo | Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities |
| FG002 | F901318 0.75 mg/kg | Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile |
| FG003 | Placebo 0.75 mg/kg | Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities |
| FG004 | F901318 1.5 mg/kg | Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile |
| FG005 | Placebo 1.5 mg/kg | Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities |
| FG006 | F901318 3 mg/kg | Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile |
| FG007 | Placebo 3 mg/kg | Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities |
| FG008 | F901318 4 mg/kg | Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile |
| FG009 | Placebo 4 mg/kg | Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Healthy volunteers
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| ID | Title | Description |
|---|---|---|
| BG000 | F901318 0.25 mg/kg | Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile |
| BG001 | 0.25 mg/kg Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Adverse Events | Adverse events will be collected from the time of screening until the final study visit | Full analytical set | Posted | Number | participants | Single dose |
|
120 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | F901318 0.25 mg/kg | Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment | Epistaxis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Anthony Kennedy | F2G | 0044 161 785 1273 | TKennedy@f2g.com |
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| ID | Term |
|---|---|
| C000626907 | olorofim |
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| F901318 mg/kg | Experimental | Single intravenous infusion over 4 hours |
|
| Placebo 3 mg/kg | Placebo Comparator | Single intravenous infusion over 4 hours |
|
| F901318 5 mg/kg | Experimental | Single intravenous infusion over 4 hours |
|
| Placebo 5 mg/kg | Placebo Comparator | Single intravenous infusion over 4 hours |
|
| Placebo | Drug | Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities |
|
Single intravenous infusion over 4 hours
Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities
| BG002 | F901318 0.75 mg/kg | Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile |
| BG003 | Placebo 0.75 mg/kg | Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities |
| BG004 | F901318 1.5 mg/kg | Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile |
| BG005 | Placebo 1.5 mg/kg | Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities |
| BG006 | F901318 3 mg/kg | Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile |
| BG007 | Placebo 3 mg/kg | Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities |
| BG008 | F901318 4 mg/kg | Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile |
| BG009 | Placebo 4 mg/kg | Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities |
| BG010 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | F901318 0.75 mg/kg | Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile |
| OG003 | Placebo 0.75 mg/kg | Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities |
| OG004 | F901318 1.5 mg/kg | Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile |
| OG005 | Placebo 1.5 mg/kg | Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities |
| OG006 | F901318 3 mg/kg | Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile |
| OG007 | Placebo 3 mg/kg | Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities |
| OG008 | F901318 4 mg/kg | Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile |
| OG009 | Placebo 4 mg/kg | Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities |
|
|
| Secondary | Number of Subjects With Significant Clinical Safety Labs and ECG Abnormalities | Number of subjects with significant Clinical safety labs and ECG abnormalities as judged by the investigator from screening until final study visit | Posted | Number | participants | Single dose |
|
|
|
| Other Pre-specified | Pharmacokinetics | Blood samples (6 mL) for analysis of F901318 plasma concentration will be drawn pre-dose and at 1h, 2h, 3h and 4h and then 4.25, 4.5, 5.0, 5.5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours following the start of the infusion. (20 samples). | Not Posted | Single dose |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | 0.25 mg/kg Placebo | Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities | 0 | 2 | 1 | 2 |
| EG002 | F901318 0.75 mg/kg | Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile | 0 | 6 | 1 | 6 |
| EG003 | Placebo 0.75 mg/kg | Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities | 0 | 2 | 1 | 2 |
| EG004 | F901318 1.5 mg/kg | Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile | 0 | 6 | 1 | 6 |
| EG005 | Placebo 1.5 mg/kg | Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities | 0 | 2 | 0 | 2 |
| EG006 | F901318 3 mg/kg | Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile | 0 | 6 | 1 | 6 |
| EG007 | Placebo 3 mg/kg | Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities | 0 | 2 | 0 | 2 |
| EG008 | F901318 4 mg/kg | Single intravenous infusion over 4 hours F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities. Pharmacokinetic profile | 0 | 6 | 1 | 6 |
| EG009 | Placebo 4 mg/kg | Single intravenous infusion over 4 hours Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities | 0 | 2 | 0 | 2 |
|
| Paraesthesia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment | Pareasthesia |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment | Pain in extremity |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment | Headache |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment | Eczema |
|
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