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Double blind, placebo controlled, ascending multiple (10) oral dose, sequential group study. Twenty-four subjects will complete the study in 3 cohorts (Groups A to C), each group consisting of 8 subjects. Each cohort will consist of 4 male and 4 female subjects. Each subject will be dosed for 10 days and will be on study for approximately 7 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 15 (120 hours post the last dose). The dose will range between 2 and 10 mg/kg daily, given as either a single daily dose or as two doses divided over the 24-hour dosing period.
All subjects will return for a post-study visit 8 to 10 days after the last dose of study medication.
Cohorts will be dosed at least at 3 weekly intervals. There will be a review of the safety and pharmacokinetic data of each cohort prior to each dose escalation.
Full description
Male and female healthy subjects conforming to the selection criteria will be invited to take part in the study.
Screening visit (Visit 1) After giving fully informed, written consent, subjects will attend the clinic.
Subjects will undergo screening within 28 days prior to the first dose administration. Prior to the screening visit, subjects will:
The following information and procedures will be recorded and performed as part of the screening assessments:
Up to 28 days after screening, subjects will attend the clinic. Subjects will be admitted to the research unit at approximately 09:00 hours in the morning the day before dosing (Day -1). Urine will be subjected to a screen for drugs of abuse and detection of any of these substances which will disqualify the subject from the study. A physical examination, check of inclusion/exclusion criteria, clinical laboratory evaluations, pregnancy test where relevant and which must be negative, oral temperature and body weight will be performed. Subjects will be asked whether they have experienced any adverse events or taken any concomitant medication since their previous visit. Supper will be served starting at approximately 19.30 hours and a snack at approximately 21.00 hours after which they will fast overnight and until 4 hours post dose. Water will be allowed ad libitum throughout.
On Day 1, the total first urine void of the morning for each subject will be collected into a polyethylene container and, from this, a sample will be taken for urinalysis and pre-dose / baseline F901318 concentration. Within one hour before dosing commences ( 1 hour), blood will be drawn for laboratory safety assessments (haematology and clinical chemistry), and pre-dose baseline F901318 and metabolites concentration. Supine and standing blood pressure and pulse rate in duplicate, body temperature and a 12-lead ECG will be recorded. The subjects will also be connected to continuous ECG recording from -1 hour) until at least 12 hours after the start of dosing.
Subjects will be asked whether they have experienced any adverse events overnight. Any concomitant medications will be recorded.
Subjects will then be dosed. This will be an oral suspension washed down with 250 mL of phosphate buffer. Subjects will be dosed with regular intervals between each subject.
After dosing, the following measurements and observations will be obtained:
Subjects may leave the Research Unit on Day 15, unless they have experienced adverse events that, in the opinion of the Investigator, warrant further observation and/or treatment.
All subjects will be followed up 8-10 days after the last dose of study drug with a post-study visit.
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40 participants in 6 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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