Invasive AspergillosisPhase 1NCT03095547
Drug/Drug Interactions With F901318
A Phase 1 study testing cyclosporine A, Posaconazole and Pantoprazole in people with Invasive Aspergillosis, run by F2G Ltd.
Trial summary
Study of interactions between F901318 and multiple doses of posaconazole and pantoprazole and single doses of cyclosporine A and tacrolimus in healthy subjects. Pharmacokinetic (PK) profiles, safety and tolerability will be assessed. 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?
- cyclosporine A, Posaconazole and Pantoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2017to Oct 2017
- 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 males and females of any ethnic origin between 18 and 55 years of age and weighing between 60 and 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
- Hepatic transaminases must be within normal limits but congenital non haemolytic hyperbilirubinaemia is acceptable.
- Negative pregnancy test in all females of child bearing potential at screening and Day -1
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
Who cannot join
- Female and male subjects who are not, or whose partners have not used for at least three months prior to screening and are not willing to use appropriate contraception during the study and for 3 months after end of dosing.
- Pregnancy and lactation.
- For cohort A only, clinically significant infection within the past 6 months or recurring herpes infections within the past 6 months or history of tuberculosis
- 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
About this study
Official title: An Open Label Assessment of the Effect of Coadministration of Posaconazole or Pantoprazole on Systemic Exposure of F901318 and the Effect of F901318 on the Single Dose Pharmacokinetics of Tacrolimus and Cyclosporine A in Healthy Male and Female Subjects
Study of interactions between F901318 and multiple doses of posaconazole and pantoprazole and single doses of cyclosporine A and tacrolimus in healthy subjects. Pharmacokinetic (PK) profiles, safety and tolerability will be assessed.
Read the detailed description
Open label randomised parallel group evaluation of three or four dosing schedules over a period of 21 days. Subjects will be randomised into the groups as follows:
- Cohort A: Pre-treat with tacrolimus 2 mg on day -9 and cyclosporine A 100 mg on Day -3 and obtain pharmacokinetic (PK) curves for both compounds prior to dosing with F901318. Then, F901318 360 mg b.i.d. for 1 or two days followed by 240 mg b.i.d. for 18 or 19 days (Days 2 or 3-20) and 240 mg o.m. on Day 21 (n=12, ideally 6 females minimum 3 females, 6 males, maximum 9 males). Dose again with tacrolimus on Day 9 and with cyclosporine A on day 16 and obtain full PK curves.
- Cohort B: F901318 360 mg b.i.d. for 1 or 2 days followed by 240 mg b.i.d. for 5 or 6 days. On Day 8, add posaconazole tablets 300 mg b.i.d. followed by 300 mg daily for 6 days (Days 9-14) and decrease F901318 dose to 120 mg daily from Day 8 onwards. On Day 15, discontinue posaconazole but continue F901318 for a further 6 days at a dose of 120 mg daily (Days 15 to 21) (n=12, ideally 6 females, 6 males).
- Cohort C: F901318 360 mg b.i.d. for one or two days followed by 240 mg b.i.d for 19 days (Day 1-20) and 240 mg o.m. on Day 21. On Day 8, add pantoprazole 40 mg daily for 7 days. On Day 15, discontinue pantoprazole but continue F901318 240 mg b.i.d to day 20 and 240 mg o.m. on Day 21 (n=12, ideally 6 females, 6 males).
- Cohort D (optional): F901318 for 21 days. Will be conducted, if necessary after completion of cohorts A-C. Dose schedule to be determined on the basis of results from ongoing study F901318-01-06-16 and cohort A of this study but could be up to 480 mg b.i.d for up to three days followed by up to 360 mg bid for 17-19 days and up to 360 o.m. on Day 21 with the objective of achieving and maintaining C12 of 1µg/mL throughout the dosing period (n=12, ideally 6 females, 6 males). The decision to proceed will be taken based on QC'd pharmacokinetic data by the PI and representative(s) of the Sponsor.
Intensive PK evaluations of F901318 and metabolite and concomitant medications will occur as follows:
- Day 1 (F901318 and metabolite alone)
- Day 7 (F901318 and metabolite alone)
- Day 14 (F901318 and metabolite and posaconazole cohort B)
- Day 21 (F901318 and metabolite)
Peak and trough levels of F901318 and metabolite (and posaconazole in cohort B on Days 8-20) will be obtained on intermediate days.
PK curves for tacrolimus will be obtained from Day -9 to Day -3 and from Day 9 to Day 15 (cohort A)
PK curves for cyclosporine A will be obtained from Day -3 to Day 1 (prior to dosing with F901318) and from Day 18 to Day 21 (cohort A)
Adverse events and 12 lead ECGs will be recorded and blood and urine samples will be obtained for safety evaluation throughout.
All subjects will return for a post-study visit 8 to 10 days after the last dose of study medication.
- Conditions
- Invasive Aspergillosis
- Being tested
- cyclosporine A, Posaconazole, Pantoprazole, F901318, Tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclosporine ADrug
Pharmacokinetic assessment Area Under the plasma concentration: time Curve (AUC) 0-t
PosaconazoleDrug
Pharmacokinetic assessment AUC 0-tau
PantoprazoleDrug
Pharmacokinetic assessment AUC 0-tau
F901318Drug
Pharmacokinetic assessment AUC 0-tau
TacrolimusDrug
Pharmacokinetic assessment AUC 0-t
| Study group | Role | What they receive |
|---|---|---|
| F901318 & cyclosporine A & tacrolimus | Experimental | Interaction between cyclosporine A and tacrolimus with F901318 Receives: Drug: cyclosporine A; Drug: F901318; Drug: Tacrolimus |
| F901318 & posaconazole | Experimental | Interaction between posaconazole and F901318 Receives: Drug: Posaconazole; Drug: F901318 |
| F901318 & pantoprazole | Experimental | Interaction between pantoprazole and F901318 Receives: Drug: Pantoprazole; Drug: F901318 |
| F901318 | Experimental | F901318 alone Receives: Drug: F901318 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Area under curve 0-t
Area under curve 0-t
Measured: 21 days
Secondary outcomes (1)
Tolerability: Adverse events
Adverse events
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study startMay 2017 (estimated)
- Primary completionJul 2017 (estimated)
- Study completionOct 2017 (estimated)
Why it stopped: study no longer required in current format
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
- Model description
- Three arm parallel group evaluation with fourth arm in series
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- F2G Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bio-Kinetic Europe, Ltd.
- Responsible party
- Sponsor
- Investigators
- David Bell, MD, Principal investigator, BioKinetic Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095547
- Sponsor's protocol ID
- F901318-01-11-17
- Status last verified
- Oct 2017
- First submitted
- 24 Mar 2017
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Assessment of the Effect of Coadministration of Posaconazole or Pantoprazole on Systemic Exposure of F901318 and the Effect of F901318 on the Single Dose Pharmacokinetics of Tacrolimus and Cyclosporine A in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT03095547
- Acronym / sponsor ID
- F901318-01-11-17
- Conditions
- Invasive Aspergillosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study no longer required in current format
- Enrolment
- 0 participants (actual)
- Lead sponsor
- F2G LtdIndustry (pharma, biotech, devices)
- Collaborators
- Bio-Kinetic Europe, Ltd.
- Study start
- May 2017 (estimated)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 29 Mar 2017 (actual)
- 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.
Study of interactions between F901318 and multiple doses of posaconazole and pantoprazole and single doses of cyclosporine A and tacrolimus in healthy subjects. Pharmacokinetic (PK) profiles, safety and tolerability will be assessed.
Detailed description
Open label randomised parallel group evaluation of three or four dosing schedules over a period of 21 days. Subjects will be randomised into the groups as follows:
- Cohort A: Pre-treat with tacrolimus 2 mg on day -9 and cyclosporine A 100 mg on Day -3 and obtain pharmacokinetic (PK) curves for both compounds prior to dosing with F901318. Then, F901318 360 mg b.i.d. for 1 or two days followed by 240 mg b.i.d. for 18 or 19 days (Days 2 or 3-20) and 240 mg o.m. on Day 21 (n=12, ideally 6 females minimum 3 females, 6 males, maximum 9 males). Dose again with tacrolimus on Day 9 and with cyclosporine A on day 16 and obtain full PK curves.
- Cohort B: F901318 360 mg b.i.d. for 1 or 2 days followed by 240 mg b.i.d. for 5 or 6 days. On Day 8, add posaconazole tablets 300 mg b.i.d. followed by 300 mg daily for 6 days (Days 9-14) and decrease F901318 dose to 120 mg daily from Day 8 onwards. On Day 15, discontinue posaconazole but continue F901318 for a further 6 days at a dose of 120 mg daily (Days 15 to 21) (n=12, ideally 6 females, 6 males).
- Cohort C: F901318 360 mg b.i.d. for one or two days followed by 240 mg b.i.d for 19 days (Day 1-20) and 240 mg o.m. on Day 21. On Day 8, add pantoprazole 40 mg daily for 7 days. On Day 15, discontinue pantoprazole but continue F901318 240 mg b.i.d to day 20 and 240 mg o.m. on Day 21 (n=12, ideally 6 females, 6 males).
- Cohort D (optional): F901318 for 21 days. Will be conducted, if necessary after completion of cohorts A-C. Dose schedule to be determined on the basis of results from ongoing study F901318-01-06-16 and cohort A of this study but could be up to 480 mg b.i.d for up to three days followed by up to 360 mg bid for 17-19 days and up to 360 o.m. on Day 21 with the objective of achieving and maintaining C12 of 1µg/mL throughout the dosing period (n=12, ideally 6 females, 6 males). The decision to proceed will be taken based on QC'd pharmacokinetic data by the PI and representative(s) of the Sponsor.
Intensive PK evaluations of F901318 and metabolite and concomitant medications will occur as follows:
- Day 1 (F901318 and metabolite alone)
- Day 7 (F901318 and metabolite alone)
- Day 14 (F901318 and metabolite and posaconazole cohort B)
- Day 21 (F901318 and metabolite)
Peak and trough levels of F901318 and metabolite (and posaconazole in cohort B on Days 8-20) will be obtained on intermediate days.
PK curves for tacrolimus will be obtained from Day -9 to Day -3 and from Day 9 to Day 15 (cohort A)
PK curves for cyclosporine A will be obtained from Day -3 to Day 1 (prior to dosing with F901318) and from Day 18 to Day 21 (cohort A)
Adverse events and 12 lead ECGs will be recorded and blood and urine samples will be obtained for safety evaluation throughout.
All subjects will return for a post-study visit 8 to 10 days after the last dose of study medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Three arm parallel group evaluation with fourth arm in series
| Arm | Type | Receives |
|---|---|---|
| F901318 & cyclosporine A & tacrolimus | Experimental | Drug: cyclosporine A, Drug: F901318, Drug: TacrolimusInteraction between cyclosporine A and tacrolimus with F901318 |
| F901318 & posaconazole | Experimental | Drug: Posaconazole, Drug: F901318Interaction between posaconazole and F901318 |
| F901318 & pantoprazole | Experimental | Drug: Pantoprazole, Drug: F901318Interaction between pantoprazole and F901318 |
| F901318 | Experimental | Drug: F901318F901318 alone |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects will be males and females of any ethnic origin between 18 and 55 years of age and weighing between 60 and 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
- Hepatic transaminases must be within normal limits but congenital non haemolytic hyperbilirubinaemia is acceptable.
- Negative pregnancy test in all females of child bearing potential at screening and Day -1
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
Key exclusion criteria (5 listed)
- Female and male subjects who are not, or whose partners have not used for at least three months prior to screening and are not willing to use appropriate contraception during the study and for 3 months after end of dosing.
- Pregnancy and lactation.
- For cohort A only, clinically significant infection within the past 6 months or recurring herpes infections within the past 6 months or history of tuberculosis
- 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
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 |
|---|---|---|
| cyclosporine APharmacokinetic assessment Area Under the plasma concentration: time Curve (AUC) 0-t | Drug | F901318 & cyclosporine A & tacrolimus |
| PosaconazolePharmacokinetic assessment AUC 0-tau | Drug | F901318 & posaconazole |
| PantoprazolePharmacokinetic assessment AUC 0-tau | Drug | F901318 & pantoprazole |
| F901318Pharmacokinetic assessment AUC 0-tau | Drug | F901318, F901318 & cyclosporine A & tacrolimus, F901318 & pantoprazole, F901318 & posaconazole |
| TacrolimusPharmacokinetic assessment AUC 0-t | Drug | F901318 & cyclosporine A & tacrolimus |
Primary outcome
Pharmacokinetics: Area under curve 0-t
Time frame: 21 days
Area under curve 0-t
1 secondary outcome
Tolerability: Adverse events
Time frame: 21 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- 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.
David Bell, MD principal investigator
BioKinetic Europe
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cyclosporine A, Posaconazole and Pantoprazole in people with Invasive Aspergillosis, run by F2G Ltd.
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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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: Area under curve 0-t (time frame: 21 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 1 Nov 2017.