Invasive AspergillosisPhase 1NCT02394483
Single Ascending Oral Dose Study of F901318
A Phase 1 study testing F901318 safety, F901318 tolerability and F901318 pharmacokinetics in people with Invasive Aspergillosis, run by F2G Ltd at 1 site in United Kingdom.
Trial summary
Double blind, placebo controlled, ascending single oral dose, sequential group study. Forty subjects will complete the study in 5 cohorts (Groups A to E), each group consisting of 8 subjects. Each subject will be on study for approximately 6 weeks. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Invasive Aspergillosis
- What is being tested?
- F901318 safety, F901318 tolerability and F901318 pharmacokinetics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Sep 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will be males of any ethnic origin between 18 and 45 years of age and with a body weight of 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.
Who cannot join
- 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 the dose administration 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 the dose administration (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.
- Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the dose administration 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.
- Subjects who have donated any blood, plasma or platelets in the 2 months prior to screening or who have made donations on more than two occasions within the 12 months preceding the dose administration.
Show all 16Show fewer
- Subjects with a significant history of drug allergy as determined by the Investigator.
- Subjects who have any clinically significant allergic disease (excluding non-active hay fever) as determined by the Investigator.
- Subjects who have a supine blood pressure and supine pulse rate higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 40 bpm, respectively, confirmed by a repeat assessment.
- Subjects who consume more than 28 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse as determined by the Investigator (one unit of alcohol equals ½ pint [285 mL] of beer or lager, one glass [125 mL] of wine, or 1/6 gill [25 mL] of spirits).
- Subjects with a positive urine drug screen or alcohol breath test result at screening or first admission.
- Subjects must not have smoked for 3 months prior to first dose administration unless otherwise specified by the Investigator or Sponsor.
- Subjects with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, ocular (including minor trauma) haematological or other major disorders as determined by the Investigator.
- Subjects who are known to have serum hepatitis, or who are carriers of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody, or who have a positive result to the test for HIV antibodies.
- Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the Investigator, increases the risk of participating in the study, such as QTcB interval >430 msec, 2nd or 3rd degree atrioventricular block, complete left bundle branch block, complete right bundle branch block or Wolff-Parkinson-White Syndrome, defined as PR<110 msec, confirmed by a repeat ECG.
- Subjects who, in the opinion of the Investigator, should not participate in the study for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: F901318 - A Phase I, Double-Blind, Placebo Controlled, Single Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Subjects
Double blind, placebo controlled, ascending single oral dose, sequential group study. Forty subjects will complete the study 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 (5 active and 1 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 data, after the first two subjects have been dosed and before dosing of the subsequent six subjects. There will be a complete review of safety and pharmacokinetic data of each cohort prior to each dose escalation.
Read the detailed description
Male 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:
- Refrain from vigorous exercise for 7 days
- Abstain from alcohol for 48 hours
- Subjects will sign the consent form in the presence of a CRU physician prior to any screening procedures being performed. The information recorded for all subjects, regardless of their suitability for the study, will be retained and archived
The following information and procedures will be recorded and performed as part of the screening assessments:
- Medical history
- Ethnic origin, sex, age, height, weight, and BMI
- Vital signs: supine blood pressure, supine pulse rate, and oral body temperature
- Resting 12 lead ECG
- Physical examination
- Urine drugs of abuse screen, cotinine and breath alcohol
- Fasting clinical laboratory and serology investigations
Up to 28 days after screening, subjects will attend the clinic. Subjects will be admitted to the research unit at approximately 13:00 hours in the afternoon the day before dosing (Day -1; -19 hours pre-dose). Urine will be subjected to a screen for drugs of abuse and there will be a breath test for alcohol and cotinine. Detection of any of these substances will disqualify the subject from the study. A physical examination, check of inclusion/exclusion criteria, clinical laboratory evaluations, 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 19.30 hours and a snack at 21.00 hours, following which subjects will be fasting. 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 triplicate, body temperature and a 12-lead ECG will be recorded. The subjects will also be connected to continuous ECG recording from -1 hour until 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.
Option 1: Subjects will then be dosed. This will be oral ingestion of a liquid formulation followed by 250 mL of water. Subjects will be dosed with regular (at least 5 minute) intervals between each subject.
After initial dosing, the following measurements and observations will be obtained:
- Blood samples for analysis of F901318 plasma concentration will be drawn at 15, 30, 45, 60, 75, 90, 120 minutes, then 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96 and 120 hours following dosing. Pharmacokinetic blood samples will be analysed and reviewed before each dose escalation. After the first dose administration, the timing of each blood sample may if necessary be adjusted within the 120-hour period for the subsequent dose escalation. The basis for this decision will depend upon the pharmacokinetic profiles obtained from the preceding group of subjects. All changes will be documented in a file note. The number of samples or volume of blood drawn must not be increased without prior approval of the relevant ethics committee.
Option 2: If it appears from pharmacokinetic measurements that oral absorption is extremely rapid, leading to a high Cmax with a relatively low AUC0-12, the dose may be split in half, with the second half being given 4-8 hours after the first. Under these circumstances, the blood sampling schedule would be decided prior to dosing but would not exceed 26 samples over a 120 hour period.
For Both Options:
- Blood samples for analysis of metabolites will be drawn 4 and 8 hours after initial dosing.
- Blood will be collected for safety measurements (haematology and clinical chemistry) 24, 48 and 72 hours post initial dosing.
- Complete urine collections for analysis of F901318 urine concentration will be made for the following intervals in relation to dosing: 0-4, 4-8, 8-12, 12-16, 16-24, 24-48, 48-72, 72-96 and 96-120 hours after initial dosing.
- Supine and standing pulse rate and blood pressure; and body temperature (vital signs) will be recorded 30, 60 and 120 minutes, 4, 8, 24, 48 and 72 hours after initial dosing.
- Twelve-lead ECGs will be obtained 1, 4, 24, 48 and 72 hours after initial dosing.
- The continuous ECG recording will cease 12 hours after initial dosing.
- Spontaneously reported adverse events will be noted throughout.
- A urine sample will be taken for urinalysis 24, 48 hours and 72 hours after initial dosing.
- Lunch will be served approximately 4 hours after initial dosing but after all the 4 hour observations and blood sampling have been completed and a main meal will be served approximately 8 hours and a snack approximately 12 hours after dosing.
Subjects may leave the Research Unit on Day 6, 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 dosing with a post-study visit.
- Conditions
- Invasive Aspergillosis
- Being tested
- F901318 safety, F901318 tolerability, F901318 pharmacokinetics, Placebo safety, Placebo tolerability
- Keywords
- Single ascending dose, double blind
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F901318 safetyDrug
Also called adverse events
Safety assessments
F901318 tolerabilityDrug
Also called adverse events
Tolerability assessments
F901318 pharmacokineticsDrug
Also called metabolism
Pharmacokinetic assessments
Placebo safetyOther
Also called adverse events
Safety assessments
Placebo tolerabilityOther
Also called adverse events
Placebo tolerability
Placebo pharmacokineticsOther
Also called metabolism
Plaacebo pharmacokinetics
| Study group | Role | What they receive |
|---|---|---|
| Cohort A active | Experimental | 2 mg/kg orally F901318 safety,F901318 tolerability and F901318 pharmacokinetics Receives: Drug: F901318 safety; Drug: F901318 tolerability; Drug: F901318 pharmacokinetics |
| Cohort A placebo | Placebo comparator | Matching placebo safety,placebo tolerability and placebo pharmacokinetics Receives: Other: Placebo safety; Other: Placebo tolerability; Other: Placebo pharmacokinetics |
| Cohort B active | Experimental | 4 mg/kg orally F901318 safety,F901318 tolerability and F901318 pharmacokinetics Receives: Drug: F901318 safety; Drug: F901318 tolerability; Drug: F901318 pharmacokinetics |
| Cohort B placebo | Placebo comparator | Matching placebo safety,placebo tolerability and placebo pharmacokinetics Receives: Other: Placebo safety; Other: Placebo tolerability; Other: Placebo pharmacokinetics |
| Cohort C active | Experimental | 6 mg/kg orally F901318 safety,F901318 tolerability and F901318 pharmacokinetics Receives: Drug: F901318 safety; Drug: F901318 tolerability; Drug: F901318 pharmacokinetics |
| Cohort C placebo | Placebo comparator | Matching placebo safety,placebo tolerability and placebo pharmacokinetics Receives: Other: Placebo safety; Other: Placebo tolerability; Other: Placebo pharmacokinetics |
| Cohort D active | Experimental | 8 mg/kg orally F901318 safety,F901318 tolerability and F901318 pharmacokinetics Receives: Drug: F901318 safety; Drug: F901318 tolerability; Drug: F901318 pharmacokinetics |
| Cohort D placebo | Placebo comparator | Matching placebo safety,placebo tolerability and placebo pharmacokinetics Receives: Other: Placebo safety; Other: Placebo tolerability; Other: Placebo pharmacokinetics |
| Cohort E active | Experimental | 10 mg/kg orally F901318 safety,F901318 tolerability and F901318 pharmacokinetics Receives: Drug: F901318 safety; Drug: F901318 tolerability; Drug: F901318 pharmacokinetics |
| Cohort E placebo | Placebo comparator | Matching placebo safety,placebo tolerability and placebo pharmacokinetics Receives: Other: Placebo safety; Other: Placebo tolerability; Other: Placebo pharmacokinetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Adverse events)
Adverse events
Measured: 10 days
Secondary outcomes (3)
Tolerability (Adverse events)
Adverse events
Measured: 10 days
Pharmacokinetics (Area under concentration time curve, AUC)
Area under concentration time curve
Measured: 120 hours
Pharmacokinetics (Cmax)
Cmax
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive AspergillosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- F2G Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec-Orion Group
- Responsible party
- Sponsor
- Investigators
- Girish Sharma, Principal investigator, Simbec Orion Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394483
- Sponsor's protocol ID
- F901318-01-03-15
- Status last verified
- Aug 2016
- First submitted
- 16 Mar 2015
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- F901318 - A Phase I, Double-Blind, Placebo Controlled, Single Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02394483
- Acronym / sponsor ID
- F901318-01-03-15
- Conditions
- Invasive Aspergillosis
- Keywords
- Single ascending dose, double blind
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- F2G LtdIndustry (pharma, biotech, devices)
- Collaborators
- Simbec-Orion Group
- Study start
- Oct 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double blind, placebo controlled, ascending single oral dose, sequential group study. Forty subjects will complete the study 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 (5 active and 1 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 data, after the first two subjects have been dosed and before dosing of the subsequent six subjects. There will be a complete review of safety and pharmacokinetic data of each cohort prior to each dose escalation.
Detailed description
Male 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:
- Refrain from vigorous exercise for 7 days
- Abstain from alcohol for 48 hours
- Subjects will sign the consent form in the presence of a CRU physician prior to any screening procedures being performed. The information recorded for all subjects, regardless of their suitability for the study, will be retained and archived
The following information and procedures will be recorded and performed as part of the screening assessments:
- Medical history
- Ethnic origin, sex, age, height, weight, and BMI
- Vital signs: supine blood pressure, supine pulse rate, and oral body temperature
- Resting 12 lead ECG
- Physical examination
- Urine drugs of abuse screen, cotinine and breath alcohol
- Fasting clinical laboratory and serology investigations
Up to 28 days after screening, subjects will attend the clinic. Subjects will be admitted to the research unit at approximately 13:00 hours in the afternoon the day before dosing (Day -1; -19 hours pre-dose). Urine will be subjected to a screen for drugs of abuse and there will be a breath test for alcohol and cotinine. Detection of any of these substances will disqualify the subject from the study. A physical examination, check of inclusion/exclusion criteria, clinical laboratory evaluations, 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 19.30 hours and a snack at 21.00 hours, following which subjects will be fasting. 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 triplicate, body temperature and a 12-lead ECG will be recorded. The subjects will also be connected to continuous ECG recording from -1 hour until 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.
Option 1: Subjects will then be dosed. This will be oral ingestion of a liquid formulation followed by 250 mL of water. Subjects will be dosed with regular (at least 5 minute) intervals between each subject.
After initial dosing, the following measurements and observations will be obtained:
- Blood samples for analysis of F901318 plasma concentration will be drawn at 15, 30, 45, 60, 75, 90, 120 minutes, then 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96 and 120 hours following dosing. Pharmacokinetic blood samples will be analysed and reviewed before each dose escalation. After the first dose administration, the timing of each blood sample may if necessary be adjusted within the 120-hour period for the subsequent dose escalation. The basis for this decision will depend upon the pharmacokinetic profiles obtained from the preceding group of subjects. All changes will be documented in a file note. The number of samples or volume of blood drawn must not be increased without prior approval of the relevant ethics committee.
Option 2: If it appears from pharmacokinetic measurements that oral absorption is extremely rapid, leading to a high Cmax with a relatively low AUC0-12, the dose may be split in half, with the second half being given 4-8 hours after the first. Under these circumstances, the blood sampling schedule would be decided prior to dosing but would not exceed 26 samples over a 120 hour period.
For Both Options:
- Blood samples for analysis of metabolites will be drawn 4 and 8 hours after initial dosing.
- Blood will be collected for safety measurements (haematology and clinical chemistry) 24, 48 and 72 hours post initial dosing.
- Complete urine collections for analysis of F901318 urine concentration will be made for the following intervals in relation to dosing: 0-4, 4-8, 8-12, 12-16, 16-24, 24-48, 48-72, 72-96 and 96-120 hours after initial dosing.
- Supine and standing pulse rate and blood pressure; and body temperature (vital signs) will be recorded 30, 60 and 120 minutes, 4, 8, 24, 48 and 72 hours after initial dosing.
- Twelve-lead ECGs will be obtained 1, 4, 24, 48 and 72 hours after initial dosing.
- The continuous ECG recording will cease 12 hours after initial dosing.
- Spontaneously reported adverse events will be noted throughout.
- A urine sample will be taken for urinalysis 24, 48 hours and 72 hours after initial dosing.
- Lunch will be served approximately 4 hours after initial dosing but after all the 4 hour observations and blood sampling have been completed and a main meal will be served approximately 8 hours and a snack approximately 12 hours after dosing.
Subjects may leave the Research Unit on Day 6, 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 dosing with a post-study visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort A active | Experimental | Drug: F901318 safety, Drug: F901318 tolerability, Drug: F901318 pharmacokinetics2 mg/kg orally F901318 safety,F901318 tolerability and F901318 pharmacokinetics |
| Cohort A placebo | Placebo comparator | Other: Placebo safety, Other: Placebo tolerability, Other: Placebo pharmacokineticsMatching placebo safety,placebo tolerability and placebo pharmacokinetics |
| Cohort B active | Experimental | Drug: F901318 safety, Drug: F901318 tolerability, Drug: F901318 pharmacokinetics4 mg/kg orally F901318 safety,F901318 tolerability and F901318 pharmacokinetics |
| Cohort B placebo | Placebo comparator | Other: Placebo safety, Other: Placebo tolerability, Other: Placebo pharmacokineticsMatching placebo safety,placebo tolerability and placebo pharmacokinetics |
| Cohort C active | Experimental | Drug: F901318 safety, Drug: F901318 tolerability, Drug: F901318 pharmacokinetics6 mg/kg orally F901318 safety,F901318 tolerability and F901318 pharmacokinetics |
| Cohort C placebo | Placebo comparator | Other: Placebo safety, Other: Placebo tolerability, Other: Placebo pharmacokineticsMatching placebo safety,placebo tolerability and placebo pharmacokinetics |
| Cohort D active | Experimental | Drug: F901318 safety, Drug: F901318 tolerability, Drug: F901318 pharmacokinetics8 mg/kg orally F901318 safety,F901318 tolerability and F901318 pharmacokinetics |
| Cohort D placebo | Placebo comparator | Other: Placebo safety, Other: Placebo tolerability, Other: Placebo pharmacokineticsMatching placebo safety,placebo tolerability and placebo pharmacokinetics |
| Cohort E active | Experimental | Drug: F901318 safety, Drug: F901318 tolerability, Drug: F901318 pharmacokinetics10 mg/kg orally F901318 safety,F901318 tolerability and F901318 pharmacokinetics |
| Cohort E placebo | Placebo comparator | Other: Placebo safety, Other: Placebo tolerability, Other: Placebo pharmacokineticsMatching placebo safety,placebo tolerability and placebo pharmacokinetics |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects will be males of any ethnic origin between 18 and 45 years of age and with a body weight of 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.
Key exclusion criteria (16 listed)
- 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 the dose administration 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 the dose administration (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.
- Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the dose administration 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F901318 safetyAlso: adverse eventsSafety assessments | Drug | Cohort A active, Cohort B active, Cohort C active, Cohort D active, Cohort E active |
| F901318 tolerabilityAlso: adverse eventsTolerability assessments | Drug | Cohort A active, Cohort B active, Cohort C active, Cohort D active, Cohort E active |
| F901318 pharmacokineticsAlso: metabolismPharmacokinetic assessments | Drug | Cohort A active, Cohort B active, Cohort C active, Cohort D active, Cohort E active |
| Placebo safetyAlso: adverse eventsSafety assessments | Other | Cohort A placebo, Cohort B placebo, Cohort C placebo, Cohort D placebo, Cohort E placebo |
| Placebo tolerabilityAlso: adverse eventsPlacebo tolerability | Other | Cohort A placebo, Cohort B placebo, Cohort C placebo, Cohort D placebo, Cohort E placebo |
| Placebo pharmacokineticsAlso: metabolismPlaacebo pharmacokinetics | Other | Cohort A placebo, Cohort B placebo, Cohort C placebo, Cohort D placebo, Cohort E placebo |
Primary outcome
Safety (Adverse events)
Time frame: 10 days
Adverse events
3 secondary outcomes
Tolerability (Adverse events)
Time frame: 10 days
Pharmacokinetics (Area under concentration time curve, AUC)
Time frame: 120 hours
Pharmacokinetics (Cmax)
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Girish Sharma principal investigator
Simbec Orion Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing F901318 safety, F901318 tolerability and F901318 pharmacokinetics in people with Invasive Aspergillosis, run by F2G Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (Adverse events) (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2016.