Invasive AspergillosisPhase 1NCT02808741
Evaluation of Immediate Release Tablet
A Phase 1 study testing F901318 SDD, F901318 IR and F901318 IR Fasting in people with Invasive Aspergillosis, run by F2G Ltd at 1 site in United Kingdom.
Trial summary
Single dose comparison of liquid and solid formulation, followed by study of effect of high fat breakfast. Evaluation of multiple dose pharmacokinetics and tolerability Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Invasive Aspergillosis
- What is being tested?
- F901318 SDD, F901318 IR and F901318 IR Fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to Nov 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will be healthy males or females of any ethnic origin between 18 and 55 years of age and weighing between 50-100 kg (body mass index of 18.0-32.0 kg/m2 inclusive).
- Females of child bearing potential must be established on a reliable form of contraception and have a negative pregnancy test at screening.
- 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
- Subjects who do not have suitable veins for multiple vene-punctures/cannulation as assessed by the investigator at screening
- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
- Male or female subjects who are not willing to use appropriate contraception during the study and until 3 months after the last dose.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: F901318 - A Two Part Study Designed to Evaluate the Single and Multiple Dose Pharmacokinetics of an Immediate Release Tablet Formulation of F901318
Single dose comparison of liquid and solid formulation, followed by study of effect of high fat breakfast.
Evaluation of multiple dose pharmacokinetics and tolerability
Read the detailed description
The study will be split into 2 parts, Part 1, ( A and B), and Part 2.
Part 1A Part 1A of the study will be a single centre, open label, 2-way crossover in healthy male and female volunteers and will assess the relative bioavailability of a single 360 mg dose (as 3 x 120mg tablets) of F901318 IR tablet formulation in comparison to a 360 mg dose of an SDD suspension for oral dosing. It is planned that 10 volunteers will be enrolled to Part 1A of the study. These 10 subjects will continue into Part 1B of the study.
There will be a minimum washout of 10 days between doses provided to volunteers.
Following Part 1A there will be a two week period of interim analysis during which safety and pharmacokinetic data will be reviewed. In order to assess doses within the therapeutic range in Part 1B, a decision will be made using the available data, on whether the dose of F901318 IR tablet formulation should be altered. Dose will be altered by amending the number of units dosed.
Part 1B Following the dose decision meeting where data obtained in Part 1A of the study is reviewed, the selected dose of F901318 IR tablet formulation will be assessed in a further single centre, open label, 2-way crossover in healthy male and female volunteers. The selected dose will be administered in the fed (30 minutes following an FDA high fat meal) and fasted states in a randomised fashion. .
There will be a minimum washout of 10 days between doses provided to volunteers.
Following Part 1B there will period a period of interim analysis during which safety and pharmacokinetic data will be reviewed. In order to assess doses within the therapeutic range in Part 2, a decision will be made using the available data, on the dose of F901318 IR formulation to be dosed in Part 2. Dose will be altered by amending the number of units dosed. It will also be determined if doses in Part 2 will be administered in the fed or fasted state.
Part 2 In part 2, the dose(s) anticipated to yield therapeutic plasma concentrations will be tested over a 10-day period. This will be a double blind placebo controlled, randomised, parallel group design in 10 healthy male and female subjects, 8 taking active compound and 2 taking placebo. In order to mimic the expected treatment schedule in phase 2 trials, it is anticipated that there will be a loading dose given over 1 or 2 days, followed by once daily or twice daily doses of study drug up to a total of 10 days.
In both parts of the study, blood will be drawn for safety and pharmacokinetic evaluation. Adverse events, vital signs and 12 lead ECGs will be monitored throughout. In Part 1, Holter monitoring will be performed for 12 hours after each dose. Part 2, ECG Holter monitoring will be performed on Days 1 and 10 only.
- Conditions
- Invasive Aspergillosis
- Being tested
- F901318 SDD, F901318 IR, F901318 IR Fasting, F901318 IR Fed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F901318 SDDDrug
Pharmacokinetics area under curve
F901318 IRDrug
Pharmacokinetics area under curve
F901318 IR FastingDrug
Pharmacokinetics area under curve
F901318 IR FedDrug
Pharmacokinetics area under curve
| Study group | Role | What they receive |
|---|---|---|
| F901318 SDD | Experimental | Liquid formulation Receives: Drug: F901318 SDD |
| F901318 IR | Experimental | Solid formulation Receives: Drug: F901318 IR |
| F901318 IR Fasting | Experimental | Fasting solid formulation Receives: Drug: F901318 IR Fasting |
| F901318 IR Fed | Experimental | Fed solid formulation Receives: Drug: F901318 IR Fed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Area Under Concentration Time Curve
Measured: 120 hours
Secondary outcomes (1)
Treatment emergent adverse events
Incidence of Treatment-Emergent Adverse Events [Safety]).
Measured: 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionNov 2016
- Study completionNov 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
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- F2G Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808741
- Sponsor's protocol ID
- F901318-01-07-16
- Status last verified
- Jun 2016
- First submitted
- 11 Jun 2016
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- F901318 - A Two Part Study Designed to Evaluate the Single and Multiple Dose Pharmacokinetics of an Immediate Release Tablet Formulation of F901318
- ClinicalTrials.gov ID
- NCT02808741
- Acronym / sponsor ID
- F901318-01-07-16
- Conditions
- Invasive Aspergillosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- F2G LtdIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Study start
- Jul 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 22 Jun 2016 (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.
Single dose comparison of liquid and solid formulation, followed by study of effect of high fat breakfast.
Evaluation of multiple dose pharmacokinetics and tolerability
Detailed description
The study will be split into 2 parts, Part 1, ( A and B), and Part 2.
Part 1A Part 1A of the study will be a single centre, open label, 2-way crossover in healthy male and female volunteers and will assess the relative bioavailability of a single 360 mg dose (as 3 x 120mg tablets) of F901318 IR tablet formulation in comparison to a 360 mg dose of an SDD suspension for oral dosing. It is planned that 10 volunteers will be enrolled to Part 1A of the study. These 10 subjects will continue into Part 1B of the study.
There will be a minimum washout of 10 days between doses provided to volunteers.
Following Part 1A there will be a two week period of interim analysis during which safety and pharmacokinetic data will be reviewed. In order to assess doses within the therapeutic range in Part 1B, a decision will be made using the available data, on whether the dose of F901318 IR tablet formulation should be altered. Dose will be altered by amending the number of units dosed.
Part 1B Following the dose decision meeting where data obtained in Part 1A of the study is reviewed, the selected dose of F901318 IR tablet formulation will be assessed in a further single centre, open label, 2-way crossover in healthy male and female volunteers. The selected dose will be administered in the fed (30 minutes following an FDA high fat meal) and fasted states in a randomised fashion. .
There will be a minimum washout of 10 days between doses provided to volunteers.
Following Part 1B there will period a period of interim analysis during which safety and pharmacokinetic data will be reviewed. In order to assess doses within the therapeutic range in Part 2, a decision will be made using the available data, on the dose of F901318 IR formulation to be dosed in Part 2. Dose will be altered by amending the number of units dosed. It will also be determined if doses in Part 2 will be administered in the fed or fasted state.
Part 2 In part 2, the dose(s) anticipated to yield therapeutic plasma concentrations will be tested over a 10-day period. This will be a double blind placebo controlled, randomised, parallel group design in 10 healthy male and female subjects, 8 taking active compound and 2 taking placebo. In order to mimic the expected treatment schedule in phase 2 trials, it is anticipated that there will be a loading dose given over 1 or 2 days, followed by once daily or twice daily doses of study drug up to a total of 10 days.
In both parts of the study, blood will be drawn for safety and pharmacokinetic evaluation. Adverse events, vital signs and 12 lead ECGs will be monitored throughout. In Part 1, Holter monitoring will be performed for 12 hours after each dose. Part 2, ECG Holter monitoring will be performed on Days 1 and 10 only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| F901318 SDD | Experimental | Drug: F901318 SDDLiquid formulation |
| F901318 IR | Experimental | Drug: F901318 IRSolid formulation |
| F901318 IR Fasting | Experimental | Drug: F901318 IR FastingFasting solid formulation |
| F901318 IR Fed | Experimental | Drug: F901318 IR FedFed solid formulation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects will be healthy males or females of any ethnic origin between 18 and 55 years of age and weighing between 50-100 kg (body mass index of 18.0-32.0 kg/m2 inclusive).
- Females of child bearing potential must be established on a reliable form of contraception and have a negative pregnancy test at screening.
- 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 (4 listed)
- Subjects who do not have suitable veins for multiple vene-punctures/cannulation as assessed by the investigator at screening
- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
- Male or female subjects who are not willing to use appropriate contraception during the study and until 3 months after the last dose.
- 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.
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 SDDPharmacokinetics area under curve | Drug | F901318 SDD |
| F901318 IRPharmacokinetics area under curve | Drug | F901318 IR |
| F901318 IR FastingPharmacokinetics area under curve | Drug | F901318 IR Fasting |
| F901318 IR FedPharmacokinetics area under curve | Drug | F901318 IR Fed |
Primary outcome
Pharmacokinetics
Time frame: 120 hours
Area Under Concentration Time Curve
1 secondary outcome
Treatment emergent adverse events
Time frame: 120 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 28 Nov 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 SDD, F901318 IR and F901318 IR Fasting 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 4 inclusion and 4 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 28 Nov 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. 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?
Pharmacokinetics (time frame: 120 hours). 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 28 Nov 2016.