Fungal DiseasePhase 1NCT05668429
ADME Study of [14^C]-Ibrexafungerp in Healthy Male Subjects
A Phase 1 study testing Ibrexafungerp in people with Fungal Disease, run by Scynexis, Inc. at 1 site in United Kingdom.
Trial summary
This is a Phase 1, open-label, single center, non-randomized study to evaluate the absorption, distribution, metabolism and excretion (ADME) of an oral solution of radiolabeled Ibrexafungerp following repeat administration in healthy male subjects. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fungal Disease
- What is being tested?
- Ibrexafungerp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Dec 2022to 28 Jan 2023
- 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 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males aged 30 to 65 years willing and able to sign and informed consent.
Who cannot join
- Clinically significant medical history or concurrent medical conditions included but not limited to infections, liver or kidney disease
- Use of certain concomitant medications
- History of smoking or alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Single-Centre Study to Evaluate the Absorption, Distribution, Metabolism and Excretion (ADME) of Oral [14^C]-Ibrexafungerp in Healthy Male Subjects After Repeat Dosing
This is a Phase 1, open-label, single center, non-randomized study to evaluate the absorption, distribution, metabolism and excretion (ADME) of an oral solution of radiolabeled Ibrexafungerp following repeat administration in healthy male subjects. All subjects will undergo preliminary screening procedures, will remain the clinical unit for approximately 26 days and will receive radiolabeled Ibrexafungerp, orally for 3 days.
- Conditions
- Fungal Disease
- Being tested
- Ibrexafungerp
- Medical subject headings
- Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrexafungerpDrug
carbon-14 ([14^C])-Ibrexafungerp
| Study group | Role | What they receive |
|---|---|---|
| Single dose of [14^C]-Ibrexafungerp | Experimental | Each subject will receive a dose of [14C]-Ibrexafungerp at 12 h intervals for 7 doses in total. Receives: Drug: Ibrexafungerp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance recovery
Mass balance recovery of total radioactivity in urine, faeces and all excreta (urine and faeces): cumulative recovery (CumAe) and cumulative recovery expressed as a percentage of the dose (Cum%Ae)
Measured: Day 26
Metabolite identification in plasma, urine and faeces
Determination of primary metabolites using liquid chromatography-radio-detection
Measured: Day 26
Area under the plasma concentration versus time curve (AUC) of Ibrexafungerp
Area under the plasma concentration versus time curve (AUC) will be estimated where possible
Measured: Day1 and Day 4
Area under the plasma concentration versus time curve (AUC) of total radioactivity
Area under the plasma concentration versus time curve (AUC) of total radioactivity in blood where possible
Measured: Day 1 and Day 4
Peak Plasma Concentration (Cmax) of Ibrexafungerp
Peak Plasma Concentration (Cmax) of Ibrexafungerp will be estimated
Measured: Day 1 and Day 4
Secondary outcomes (3)
Routes and rates of elimination of [14^C]-Ibrexafungerp
Determination of routes and rates of elimination of [14C]-Ibrexafungerp primarily by Ae total radioactivity for urine and faeces.
Measured: Day 26
Distribution of total radioactivity into blood cells
Evaluation of whole blood plasma concentration ratios for total radioactivity
Measured: Day 4
Safety of Ibrexafungerp
Number of participants with treatment-related adverse events as assessed by the investigator.
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start14 Dec 2022
- Primary completion28 Jan 2023
- Study completion28 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scynexis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668429
- Sponsor's protocol ID
- SCY-078-122
- Status last verified
- Jun 2023
- First submitted
- 8 Dec 2022
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single-Centre Study to Evaluate the Absorption, Distribution, Metabolism and Excretion (ADME) of Oral [14^C]-Ibrexafungerp in Healthy Male Subjects After Repeat Dosing
- ClinicalTrials.gov ID
- NCT05668429
- Acronym / sponsor ID
- SCY-078-122
- Conditions
- Fungal Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Scynexis, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 28 Jan 2023 (actual)
- Study completion
- 28 Jan 2023 (actual)
- First posted
- 29 Dec 2022 (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.
This is a Phase 1, open-label, single center, non-randomized study to evaluate the absorption, distribution, metabolism and excretion (ADME) of an oral solution of radiolabeled Ibrexafungerp following repeat administration in healthy male subjects. All subjects will undergo preliminary screening procedures, will remain the clinical unit for approximately 26 days and will receive radiolabeled Ibrexafungerp, orally for 3 days.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single dose of [14^C]-Ibrexafungerp | Experimental | Drug: IbrexafungerpEach subject will receive a dose of [14C]-Ibrexafungerp at 12 h intervals for 7 doses in total. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy males aged 30 to 65 years willing and able to sign and informed consent.
Key exclusion criteria (3 listed)
- Clinically significant medical history or concurrent medical conditions included but not limited to infections, liver or kidney disease
- Use of certain concomitant medications
- History of smoking or alcohol abuse
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 |
|---|---|---|
| Ibrexafungerpcarbon-14 ([14^C])-Ibrexafungerp | Drug | Single dose of [14^C]-Ibrexafungerp |
Primary outcome
Mass balance recovery
Time frame: Day 26
Mass balance recovery of total radioactivity in urine, faeces and all excreta (urine and faeces): cumulative recovery (CumAe) and cumulative recovery expressed as a percentage of the dose (Cum%Ae)
Metabolite identification in plasma, urine and faeces
Time frame: Day 26
Determination of primary metabolites using liquid chromatography-radio-detection
Area under the plasma concentration versus time curve (AUC) of Ibrexafungerp
Time frame: Day1 and Day 4
Area under the plasma concentration versus time curve (AUC) will be estimated where possible
Area under the plasma concentration versus time curve (AUC) of total radioactivity
Time frame: Day 1 and Day 4
Area under the plasma concentration versus time curve (AUC) of total radioactivity in blood where possible
Peak Plasma Concentration (Cmax) of Ibrexafungerp
Time frame: Day 1 and Day 4
Peak Plasma Concentration (Cmax) of Ibrexafungerp will be estimated
3 secondary outcomes
Routes and rates of elimination of [14^C]-Ibrexafungerp
Time frame: Day 26
Distribution of total radioactivity into blood cells
Time frame: Day 4
Safety of Ibrexafungerp
Time frame: Day 4
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 Jun 2023.
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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 Ibrexafungerp in people with Fungal Disease, run by Scynexis, Inc. 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 1 inclusion and 3 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 Jun 2023. 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?
Mass balance recovery (time frame: Day 26). The study lists 5 primary outcomes in all. 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 Jun 2023.