Fungal InfectionPhase 1NCT04307082
ADME Study of [14C]-Ibrexafungerp in Healthy Male Subjects
A Phase 1 study testing [14C]-Ibrexafungerp in people with Fungal Infection, run by Scynexis, Inc. at 1 site in United Kingdom.
Trial summary
This is a Phase 1, open-label, single-centre, non-randomised study to evaluate the absorption, distribution, metabolism, and excretion (ADME) of an oral solution of [14C]-ibrexafungerp following 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 Infection
- What is being tested?
- [14C]-Ibrexafungerp
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Dec 2019to 30 Jun 2020
- 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
- Age 30 to 65 years of age at the time of signing informed consent
- Must be willing and able to participate in the whole study
- Must provide written informed consent
- Must agree to adhere to the contraception requirements
Who cannot join
- Subjects who have received any investigational drug in a clinical research study within the 90 days prior to Day 1
- Current smokers
- Recent radiation exposure
- Subjects who have been enrolled in a 14C ADME study in the last 12 months
- An acute or chronic disease determined by the investigator to be clinically significant
- Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis at screening as judged by the investigator
- Evidence of renal impairment at screening
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder
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 [14C]-Ibrexafungerp in Healthy Male Subjects
This is a Phase 1, open-label, single-centre, non-randomised study to evaluate the absorption, distribution, metabolism, and excretion (ADME) of an oral solution of [14C]-ibrexafungerp following administration in healthy male subjects.
Each subject will receive a single dose of [14C]-ibrexafungerp and will be followed for up to 20 days. During this period total radioactivity will be measured in blood, urine and faeces.
Read the detailed description
This is a Phase 1, open-label, single-centre, non-randomised study to evaluate the absorption, distribution, metabolism, and excretion (ADME) of an oral solution of [14C]-ibrexafungerp following administration in healthy male subjects.
Each subject will receive a single dose of [14C]-ibrexafungerp and will be followed for up to 20 days. During this period total radioactivity will be measured in blood, urine and faeces.
All subjects will undergo preliminary screening procedures for the study at the screening visit. Subjects will be admitted to the clinical unit on the evening prior to dosing (Day -1). A single oral dose containing [14C]-ibrexafungerp oral solution will be administered to subjects. Individual subjects will be released from the clinical unit following study-related procedures on Days 8 to 20 according to their % of radioactivity collected in relation to the dose administered.
- Conditions
- Fungal Infection
- Being tested
- [14C]-Ibrexafungerp
- Keywords
- SCY-078, Ibrexafungerp, ADME
- Medical subject headings
- Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-IbrexafungerpDrug
Also called [14C]-SCY-078
Radio-labeled Ibrexafungerp, single dose.
| Study group | Role | What they receive |
|---|---|---|
| Ibrexafungerp | Experimental | Oral [14C]-Ibrexafungerp Single Dose Receives: Drug: [14C]-Ibrexafungerp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance
Amount recovered expressed as a percentage of the dose administered
Measured: Day 20
Secondary outcomes (2)
Routes and rates of elimination of [14C]-ibrexafungerp
Metabolite concentrations in body fluids and excreta
Measured: Day 20
Number of subjects with treatment-emergent adverse events
Number of subjects with treatment-emergent adverse events
Measured: Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start5 Dec 2019
- Primary completion29 May 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal InfectionStudies 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
- Model description
- Open Label, single arm
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scynexis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inncelerex
- Responsible party
- Sponsor
- Investigators
- Nkechi Azie, MD, Study director, Scynexis, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307082
- Sponsor's protocol ID
- SCY-078-116
- Status last verified
- Aug 2020
- First submitted
- 4 Mar 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. 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 [14C]-Ibrexafungerp in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04307082
- Acronym / sponsor ID
- SCY-078-116
- Conditions
- Fungal Infection
- Keywords
- SCY-078, Ibrexafungerp, ADME
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Scynexis, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Inncelerex
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 13 Mar 2020 (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-centre, non-randomised study to evaluate the absorption, distribution, metabolism, and excretion (ADME) of an oral solution of [14C]-ibrexafungerp following administration in healthy male subjects.
Each subject will receive a single dose of [14C]-ibrexafungerp and will be followed for up to 20 days. During this period total radioactivity will be measured in blood, urine and faeces.
Detailed description
This is a Phase 1, open-label, single-centre, non-randomised study to evaluate the absorption, distribution, metabolism, and excretion (ADME) of an oral solution of [14C]-ibrexafungerp following administration in healthy male subjects.
Each subject will receive a single dose of [14C]-ibrexafungerp and will be followed for up to 20 days. During this period total radioactivity will be measured in blood, urine and faeces.
All subjects will undergo preliminary screening procedures for the study at the screening visit. Subjects will be admitted to the clinical unit on the evening prior to dosing (Day -1). A single oral dose containing [14C]-ibrexafungerp oral solution will be administered to subjects. Individual subjects will be released from the clinical unit following study-related procedures on Days 8 to 20 according to their % of radioactivity collected in relation to the dose administered.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label, single arm
| Arm | Type | Receives |
|---|---|---|
| Ibrexafungerp | Experimental | Drug: [14C]-IbrexafungerpOral [14C]-Ibrexafungerp Single Dose |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy males
- Age 30 to 65 years of age at the time of signing informed consent
- Must be willing and able to participate in the whole study
- Must provide written informed consent
- Must agree to adhere to the contraception requirements
Key exclusion criteria (8 listed)
- Subjects who have received any investigational drug in a clinical research study within the 90 days prior to Day 1
- Current smokers
- Recent radiation exposure
- Subjects who have been enrolled in a 14C ADME study in the last 12 months
- An acute or chronic disease determined by the investigator to be clinically significant
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 |
|---|---|---|
| [14C]-IbrexafungerpAlso: [14C]-SCY-078Radio-labeled Ibrexafungerp, single dose. | Drug | Ibrexafungerp |
Primary outcome
Mass balance
Time frame: Day 20
Amount recovered expressed as a percentage of the dose administered
2 secondary outcomes
Routes and rates of elimination of [14C]-ibrexafungerp
Time frame: Day 20
Number of subjects with treatment-emergent adverse events
Time frame: Day 20
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 14 Aug 2020.
- 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.
Nkechi Azie, MD study director
Scynexis, Inc.
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 [14C]-Ibrexafungerp in people with Fungal Infection, 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 5 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: finished, as of the sponsor's last update on 14 Aug 2020. 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 (time frame: Day 20). 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 14 Aug 2020.