Invasive AspergillosisPhase 1ADMENCT02912026
Radiolabelled IV and Oral Metabolism Study of F901318
A Phase 1 study testing IV F901318 and Oral F901318 in people with Invasive Aspergillosis, run by F2G Ltd at 1 site in United Kingdom.
Trial summary
Open label radiolabelled metabolism study of intravenous and oral solution forms of F901318. Five healthy male subjects will receive IV and five will receive an oral solution. Blood, urine and faeces will be collected over a period adequate to obtain 90% recovery of parent compound and to determine the metabolic… Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Invasive Aspergillosis
- What is being tested?
- IV F901318 and Oral F901318
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2019to Jul 2019
- 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 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males who do not wish to father children within the 6 months following IMP administration.
- Age 40 to 65 years of age at the time of signing the ICF.
- Body mass index of 18.0 to 35.0 kg/m2, with a weight of 50 to 100 kg.
- Must be willing and able to communicate and participate in the whole study.
- Subjects must be in good health as determined by a medical history, physical examination, 12-lead ECG and clinical laboratory evaluations.
- Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day).
- Must provide written informed consent and agree to abide by the study restrictions
- Must agree to use an adequate method of contraception during the study and for 6 months after study discharge
Who cannot join
- Subjects who have received any IMP in a clinical research study within the previous 3 months prior to dosing.
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
- Subjects who have previously been enrolled in this study or have previously been exposed to F901318.
- History of any drug or alcohol abuse in the past 2 years.
- Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).
- Current smokers and those who have smoked or used nicotine containing products (eg electronic cigarettes) within the last 6 months. A confirmed positive urine cotinine test at screening or admission.
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study.
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Clinical
Nottingham, Nottinghamshire, NG11 6JS
About this study
Official title: An Open-Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-F901318 Administered Via the Intravenous and Oral Routes to Healthy Male Subjects
Open label radiolabelled metabolism study of intravenous and oral solution forms of F901318. Five healthy male subjects will receive IV and five will receive an oral solution. Blood, urine and faeces will be collected over a period adequate to obtain 90% recovery of parent compound and to determine the metabolic profile of both IV and oral forms.
Read the detailed description
Subjects will be screened for eligibility to participate in the study up to 28 days before dosing. Eligible subjects will be admitted to the clinical unit on the evening of Day -1 prior to investigational medicinal product (IMP) administration, and will be dosed on the morning of Day 1. In Cohort 1 (Regimen A), subjects will be dosed after a light breakfast; to assess tolerability of the IV administration, the first subject will be dosed at least 30 min prior to dosing the second subject. All subsequent dosing of the IV formulation will be staggered by at least 15 min. In Cohort 2 (Regimen B), subjects will be dosed following an overnight fast with an appropriate interval between subjects based on logistical requirements. Subjects will remain resident in the clinic up to 336 h post-dose (Day 15). It is planned that subjects will return to the clinical unit for 2 further 24 h residency periods on Day 21 and Day 28 if discharge criteria outlined in this protocol are not met. It is planned that subjects will be released from the study as a group when all subjects have achieved a mass balance cumulative recovery of >90% or <1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 h periods. If this occurs earlier than Day 28, collection of all samples (blood, urine and faeces) will be stopped and the subjects will undergo discharge assessments. If this criterion has not been met by all subjects following the Day 28 return visit, home collections of urine and faeces may be requested at the discretion of the investigator for individual subjects.
- Conditions
- Invasive Aspergillosis
- Being tested
- IV F901318, Oral F901318
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV F901318Drug
Metabolic profile AUC 0 to infinity
Oral F901318Drug
Metabolic profile AUC 0 to infinity
| Study group | Role | What they receive |
|---|---|---|
| Intravenous | Experimental | Intravenous AUC0-infinity Receives: Drug: IV F901318 |
| Oral | Experimental | Oral AUC0-infinity Receives: Drug: Oral F901318 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance
Metabolic profiling over 28 days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startMay 2019 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Why it stopped: Major change to study design
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT02912026
- Sponsor's protocol ID
- F901318-01-08-16
- Acronym
- ADME
- Status last verified
- Jul 2018
- First submitted
- 21 Sep 2016
- Last updated
- 26 Jul 2019
- 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 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-F901318 Administered Via the Intravenous and Oral Routes to Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02912026
- Acronym / sponsor ID
- ADME / F901318-01-08-16
- Conditions
- Invasive Aspergillosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Major change to study design
- Enrolment
- 0 participants (actual)
- Lead sponsor
- F2G LtdIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Study start
- May 2019 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 23 Sep 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.
Open label radiolabelled metabolism study of intravenous and oral solution forms of F901318. Five healthy male subjects will receive IV and five will receive an oral solution. Blood, urine and faeces will be collected over a period adequate to obtain 90% recovery of parent compound and to determine the metabolic profile of both IV and oral forms.
Detailed description
Subjects will be screened for eligibility to participate in the study up to 28 days before dosing. Eligible subjects will be admitted to the clinical unit on the evening of Day -1 prior to investigational medicinal product (IMP) administration, and will be dosed on the morning of Day 1. In Cohort 1 (Regimen A), subjects will be dosed after a light breakfast; to assess tolerability of the IV administration, the first subject will be dosed at least 30 min prior to dosing the second subject. All subsequent dosing of the IV formulation will be staggered by at least 15 min. In Cohort 2 (Regimen B), subjects will be dosed following an overnight fast with an appropriate interval between subjects based on logistical requirements. Subjects will remain resident in the clinic up to 336 h post-dose (Day 15). It is planned that subjects will return to the clinical unit for 2 further 24 h residency periods on Day 21 and Day 28 if discharge criteria outlined in this protocol are not met. It is planned that subjects will be released from the study as a group when all subjects have achieved a mass balance cumulative recovery of >90% or <1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 h periods. If this occurs earlier than Day 28, collection of all samples (blood, urine and faeces) will be stopped and the subjects will undergo discharge assessments. If this criterion has not been met by all subjects following the Day 28 return visit, home collections of urine and faeces may be requested at the discretion of the investigator for individual subjects.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous | Experimental | Drug: IV F901318Intravenous AUC0-infinity |
| Oral | Experimental | Drug: Oral F901318Oral AUC0-infinity |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy males who do not wish to father children within the 6 months following IMP administration.
- Age 40 to 65 years of age at the time of signing the ICF.
- Body mass index of 18.0 to 35.0 kg/m2, with a weight of 50 to 100 kg.
- Must be willing and able to communicate and participate in the whole study.
- Subjects must be in good health as determined by a medical history, physical examination, 12-lead ECG and clinical laboratory evaluations.
Key exclusion criteria (8 listed)
- Subjects who have received any IMP in a clinical research study within the previous 3 months prior to dosing.
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
- Subjects who have previously been enrolled in this study or have previously been exposed to F901318.
- History of any drug or alcohol abuse in the past 2 years.
- Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).
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 |
|---|---|---|
| IV F901318Metabolic profile AUC 0 to infinity | Drug | Intravenous |
| Oral F901318Metabolic profile AUC 0 to infinity | Drug | Oral |
Primary outcome
Mass balance
Time frame: 28 days
Metabolic profiling over 28 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 26 Jul 2019.
- 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 IV F901318 and Oral F901318 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 8 inclusion and 8 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 26 Jul 2019. 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 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?
Mass balance (time frame: 28 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 26 Jul 2019.