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F901318 Single Ascending Dose Study in Healthy Male Volunteers

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.
 
ClinicalTrials.gov Identifier: NCT02142153
Recruitment Status : Completed
First Posted : May 20, 2014
Results First Posted : September 7, 2015
Last Update Posted : September 7, 2015
Sponsor:
Collaborator:
Simbec Research
Information provided by (Responsible Party):
F2G Ltd.

Brief Summary:
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.

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

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: F901318 - A Phase I, Double-Blind, Placebo Controlled, Single Ascending Intravenous Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Subjects
Study Start Date : August 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Arm Intervention/treatment
Experimental: F901318 0.25 mg/kg
Single intravenous infusion over 4 hours
Drug: F901318

Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.

Pharmacokinetic profile


Placebo Comparator: 0.25 mg/kg placebo
Single intravenous infusion over 4 hours
Drug: Placebo
Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities

Experimental: F901318 0.75 mg/kg
Single intravenous infusion over 4 hours
Drug: F901318

Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.

Pharmacokinetic profile


Placebo Comparator: Placebo 0.75 mg/kg
Single intravenous infusion over 4 hours
Drug: Placebo
Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities

Experimental: F901318 1.5 mg/kg
Single intravenous infusion over 4 hours
Drug: F901318

Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.

Pharmacokinetic profile


Placebo Comparator: Placebo 1.5 mg/kg
Single intravenous infusion over 4 hours
Drug: Placebo
Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities

Experimental: F901318 mg/kg
Single intravenous infusion over 4 hours
Drug: F901318

Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.

Pharmacokinetic profile


Placebo Comparator: Placebo 3 mg/kg
Single intravenous infusion over 4 hours
Drug: Placebo
Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities

Experimental: F901318 5 mg/kg
Single intravenous infusion over 4 hours
Drug: F901318

Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.

Pharmacokinetic profile


Placebo Comparator: Placebo 5 mg/kg
Single intravenous infusion over 4 hours
Drug: Placebo
Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities




Primary Outcome Measures :
  1. Number of Subjects With Adverse Events [ Time Frame: Single dose ]
    Adverse events will be collected from the time of screening until the final study visit


Secondary Outcome Measures :
  1. Number of Subjects With Significant Clinical Safety Labs and ECG Abnormalities [ Time Frame: Single dose ]
    Number of subjects with significant Clinical safety labs and ECG abnormalities as judged by the investigator from screening until final study visit


Other Outcome Measures:
  1. Pharmacokinetics [ Time Frame: Single dose ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects will be males of any ethnic origin between 18 and 45 years of age and weighing 60-90 kg inclusive
  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

Exclusion Criteria:

  1. Male subjects who are not, or whose partners are not willing to use appropriate contraception (such as a condom) with established use of oral, injected or implanted hormonal contraceptive, intrauterine device or diaphragm with spermicide for three months after the last dose
  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) 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

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 ClinicalTrials.gov identifier (NCT number): NCT02142153


Locations
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United Kingdom
Simbec Research
Merthyr Tydfil, Mid Glamorgan, United Kingdom, CF48 4DR
Sponsors and Collaborators
F2G Ltd.
Simbec Research
Investigators
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Principal Investigator: Salvatore Febbraro, MD Simbec Research
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Responsible Party: F2G Ltd.
ClinicalTrials.gov Identifier: NCT02142153    
Other Study ID Numbers: F901318-01-01-14
2014-000823-25 ( EudraCT Number )
First Posted: May 20, 2014    Key Record Dates
Results First Posted: September 7, 2015
Last Update Posted: September 7, 2015
Last Verified: June 2015
Keywords provided by F2G Ltd.:
First in man
Antifungal
Intravenous infusion
Healthy volunteers
Additional relevant MeSH terms:
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Aspergillosis
Mycoses
Olorofim
Antifungal Agents
Anti-Infective Agents