Safety and TolerabilityPhase 1NCT06181760
A Study to Evaluate the Safety of Fenretinide in Healthy Volunteers
A Phase 1 study testing Fenretinide in people with Safety and Tolerability, run by Island Pharmaceuticals at 1 site in Australia.
Trial summary
The goal of this clinical trial was to learn about a single dose of fenretinide in healthy volunteers, in both a fasted and fed state. The main questions to answer were: How well is a single dose of fenretinide tolerated? AND How is a single dose of fenretinide metabolized in healthy volunteers? Participants will be… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability
- What is being tested?
- Fenretinide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteAustralia
- Study dates
- 22 Nov 2023to 13 Feb 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female volunteers not of childbearing potential, who are 18 years to 65 years of age (inclusive) at the time of signing the informed consent form (ICF).
- Females not of childbearing potential, as defined in the following criteria:
- History of hysterectomy.
- Post-menopausal.
- Natural post-menopausal females with at least 12 months from natural spontaneous amenorrhea and a serum follicle-stimulating hormone (FSH) concentration ≥ 40 IU/L.
- Post-surgical females must have undergone bilateral oophorectomy at least 6 weeks prior to study.
Show all 17Show fewer
- Male subjects with female partners of childbearing potential must agree to practice abstinence or use a combination of 2 of the following acceptable birth control methods during the study and for at least 90 days after dosing:
- Partners have an intrauterine device (IUD) without hormones in place for at least 3 months.
- Barrier method (condom or diaphragm) for at least 14 days prior to screening and 90 days after dosing with study drug.
- Partners using stable hormonal contraceptive for at least 3 months prior to screening and for 90 days after dosing with study drug.
- History of vasectomy at least 3 months prior to signing the ICF.
- Must be able to understand and provide signed informed consent for study participation.
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Body mass index (BMI) 18.0 to 32.0 kg/m2 (inclusive), and a body weight ≥ 50 kg.
- Normal renal function, defined as estimated glomerular filtration rate (eGFR) ≥ 70 mL/min/1.73 m2 at screening and Day -1.
- Clinical laboratory values should be within the laboratory's stated normal range. If not within this range, they must be without clinical significance, as determined by the Investigator.
- No history of clinically relevant medical disorders, as determined by the Investigator.
Who cannot join
- Known or suspected pregnancy (confirmed via a positive serum human chorionic gonadotropin [hCG] pregnancy test at screening), planned pregnancy during the study period, nursing, or lactation.
- Women of childbearing potential or men who intend to father a child or donate sperm during the study period and for 3 months after study drug administration.
- Known allergy to fenretinide or any of the components of ISLA101.
- Evidence or history of clinically significant medical conditions, such as hematological, renal, endocrine (e.g., polycystic ovarian syndrome or other anovulatory states), immunologic, pulmonary, metabolic, gastrointestinal (e.g., Crohn's disease, acute or chronic pancreatitis, and others) and surgery (except for simple appendectomy or repair of a hernia), which all can influence the absorption of study drug; cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), or any other illness that the Investigator considers exclusionary or that could interfere with the interpretation of the study results.
- History of severe infectious disease or recurrent infections.
- Aspartate transaminase (AST), alanine aminotransferase (ALT), or total bilirubin above the 1.5 x upper limit of normal (ULN) at screening and Day -1.
Show all 27Show fewer
- Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities at screening and Day -1, long QT syndrome, or a history of cardiac disease.
- Abnormal diet that may affect absorption, distribution, metabolism, or excretion of drugs, for example, lacking standard nutrients (e.g, cleansing diet 2 weeks before or during the study).
- Positive result for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening.
- History of positive test for tuberculosis (TB) at screening.
- A subject who has donated 1 unit of blood of over 500 mL within 56 days prior to the study drug administration, or donated plasma within 14 days prior to study drug administration.
- Use of systemic antibiotics within 30 days prior to dosing.
- Any use of drugs that inhibit or induce CYP enzymes within 30 days prior to administration of study drug and for the duration of study participation.
- Use of any tobacco products, e-cigarettes, and/or nicotine replacement products in the 3 months preceding screening.
- Any food allergy, intolerance, or restriction that, in the opinion of the Investigator, could contraindicate the subject's participation in this study.
- Recent history of (within the past 12 months), or strong potential for, alcohol or substance abuse. Alcohol abuse will be defined as > 14 drinks per week (1 drink = 10g of ethanol).
- History of drug or alcohol abuse within 5 years before screening or positive result of UDS (e.g, amphetamines, benzodiazepines, cannabinoids, cocaine, hallucinogens, opiates) or alcohol breath test at screening.
- Exposure to any investigational agent or used an invasive investigational medical device within 30 days or within a period less than 5 drug half-lives prior to study entry (whichever is longer).
- Study site employees, Sponsor's employees, or immediate family members of a study site or Sponsor employee.
- Previously enrolled in this study.
- Vaccination 14 days from screening or plans to get a vaccine within 30 days after dosing.
- Acute infection (such as influenza) or relevant lesion at the time of Screening or Day -1. Subjects can be rescreened once they have recovered.
- Criteria at the discretion of the Investigator:
- Chronic medical condition that impacts subject safety.
- Clinically significant abnormal physical examination or vital signs at screening.
- Condition believed to interfere with the subject's ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk.
- History or evidence of a clinically significant disorder, condition, or disease that that is believed to significantly impair pain perception (e.g., history of stroke, history of neuropathy), would pose a risk to subject safety or interfere with evaluation, procedures, or study completion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1a, Randomized, Double-blind Placebo-controlled Study to Evaluate Safety and Tolerability and to Characterize the Pharmacokinetic Profile of Single Ascending Doses of Fenretinide Oral Capsules in Healthy Adult Volunteers
The goal of this clinical trial was to learn about a single dose of fenretinide in healthy volunteers, in both a fasted and fed state. The main questions to answer were:
- How well is a single dose of fenretinide tolerated? AND
- How is a single dose of fenretinide metabolized in healthy volunteers?
Read more
Participants will be asked to:
- Remain confined in a clinical research unit for 5 days after dosing.
- Provide blood samples for intense PK sampling and safety labs.
- Fast for 10 hours prior to administration of study drug (fasted cohorts).
- Consume a high fat meal prior to administration of study drug (fed cohort).
- Return to the clinic for a single follow-up visit for safety assessments.
The study will compare active fenretinide to placebo to see if fenretinide is more or less tolerable than placebo.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled single ascending dose study. There are 3 planned dose-level cohorts (Cohorts 1-3). Each dose-level cohort will consist of 8 subjects (6 active + 2 placebo), who will be treated under fasted conditions. The subjects in the highest tolerated dose-level cohort (determined by the Safety Review Committee) will also be administered ISLA101 or placebo under fed conditions, in a cross-over manner (Cohort 4).
Proposed doses are 300, 600, and 900 mg/m^2 (equivalent to 8.1, 16.2, and 24.3 mg/kg). Each subject will be allocated to 1 dose level only.
The study will include a 5-day stay in the clinical research unit followed by a final safety follow-up visit at Day 8, where subjects will be under fasted conditions when they are dosed on Study Day 1.
For cohort 4, the study will again include a 5-day stay in the clinical research unit followed by a final safety follow-up visit at Day 17, where subjects will be under fed conditions when they are dosed on Study Day 10.
- Conditions
- Safety and Tolerability
- Being tested
- Fenretinide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenretinideDrug
Ascending single doses of oral fenretinide
PlaceboDrug
Single oral dose of matching placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Fenretinide 300 mg/m^2 | Active comparator | Single oral dose of fenretinide, 300 mg/m^2 under fasted conditions (Phase 1) Receives: Drug: Fenretinide |
| Fenretinide 600 mg/m^2 | Active comparator | Single oral dose of fenretinide, 600 mg/m^2 under fasted conditions (Phase 1)
Once all groups finish Phase 1, return to complete Phase 2 with a single oral dose of fenretinide, 600 mg/m^2 under fed conditions per recommendation from the independent Safety Review Committee. Receives: Drug: Fenretinide |
| Fenretinide 900 mg/m^2 | Active comparator | Single oral dose of fenretinide, 900 mg/m^2 under fasted conditions (Phase 1) Receives: Drug: Fenretinide |
| Placebo | Placebo comparator | Single oral dose of placebo capsules under fasted conditions (Phase 1)
Once all groups finish Phase 1, return to complete Phase 2 with a single oral dose of placebo capsules under fed conditions per recommendation from the independent Safety Review Committee. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and % of Subjects Experiencing Adverse Events Following a Single Oral Dose of Fenretinide Under Fasted Conditions
Measured: First Intervention (Day 1 to Day 8)
Number and % of Subjects Experiencing Serious Adverse Events Following a Single Oral Dose of Fenretinide Under Fasted Conditions
25 total subjects were enrolled in the study.
Measured: First Intervention (Day 1 to Day 8)
Number and % of Subjects Experiencing Adverse Events Following a Single Oral Dose of Fenretinide Under Fed Conditions
Subjects in the 600 mg/m^2 came back to complete the fed cohort, as this was the only group to return based on the recommendations by the Safety Review Committee. Only 4 out of the 6 subjects returned for this cohort (i.e., 3 subjects on ISLA101 and 1 subject on placebo).
Measured: Second Intervention (Day 9 to Day 17)
Number and % of Subjects Experiencing Serious Adverse Events Following a Single Oral Dose of Fenretinide Under Fed Conditions
25 total subjects were enrolled in the study. After all fasted cohorts completed (i.e., 300 mg/m^2, 600 mg/m^2, 900 mg/m^2 as well as placebo) data was reviewed by the independent Safety Review Committee. The recommendation was to bring back the 600 mg/m^2 group to complete the fed cohort and only 4 out of the 6 subjects were available (i.e., 3 subjects on ISLA101 and 1 subject on placebo).
Measured: Second Intervention (Day 9 to 17)
Secondary outcomes (5)
Assess the CMax - Observed Maximum Plasma Concentration Following a Single Oral Dose of Fenretinide
Secondary objective
Measured: First Intervention (Day 1 to Day 8), washout period, Second Intervention (Day 9-17)
Assess the TMax - Time to Reach Maximum Concentration Curve Following a Single Oral Dose of Fenretinide in the Fasted and Fed State
25 total subjects were enrolled in the study. After all fasted cohorts completed (i.e., 300 mg/m^2, 600 mg/m^2, 900 mg/m^2 as well as placebo) data was reviewed by the independent Safety Review Committee. The recommendation was to bring back the 600 mg/m^2 group to complete the fed cohort and only 4 out of the 6 subjects were available (i.e., 3 subjects on ISLA101 and 1 subject on placebo).
Measured: First Intervention (Day 1 to Day 8), washout period, Second Intervention (Day 9-17)
Assess the AUC-∞ Area Under the Concentration Curve From Zero to Infinite Time Following a Single Oral Dose of Fenretinide in the Fasted and Fed State
25 total subjects were enrolled in the study. After all fasted cohorts completed (i.e., 300 mg/m^2, 600 mg/m^2, 900 mg/m^2 as well as placebo) data was reviewed by the independent Safety Review Committee. The recommendation was to bring back the 600 mg/m^2 group to complete the fed cohort and only 4 out of the 6 subjects were available (i.e., 3 subjects on ISLA101 and 1 subject on placebo).
Measured: First Intervention (Day 1 to Day 8), washout period, Second Intervention (Day 9-17)
Assess the AUC(Last) - Area Under the Curve up to the Last Quantifiable Timepoint After a Single Oral Dose of Fenretinide in the Fasted and Fed State
25 total subjects were enrolled in the study. After all fasted cohorts completed (i.e., 300 mg/m^2, 600 mg/m^2, 900 mg/m^2 as well as placebo) data was reviewed by the independent Safety Review Committee. The recommendation was to bring back the 600 mg/m^2 group to complete the fed cohort and only 4 out of the 6 subjects were available (i.e., 3 subjects on ISLA101 and 1 subject on placebo).
Measured: First Intervention (Day 1 to Day 8), washout period, Second Intervention (Day 9-17)
Assess the Half Life of a Single Oral Dose of Fenretinide in the Fasted and Fed State
25 total subjects were enrolled in the study. After all fasted cohorts completed (i.e., 300 mg/m^2, 600 mg/m^2, 900 mg/m^2 as well as placebo) data was reviewed by the independent Safety Review Committee. The recommendation was to bring back the 600 mg/m^2 group to complete the fed cohort and only 4 out of the 6 subjects were available (i.e., 3 subjects on ISLA101 and 1 subject on placebo).
Measured: First Intervention (Day 1 to Day 8), washout period, Second Intervention (Day 9-17)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start22 Nov 2023
- Primary completion13 Feb 2024
- Study completion13 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Safety and TolerabilityStudies 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
- Randomized, double-blind, placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Island Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beyond Drug Development
- Responsible party
- Sponsor
- Investigators
- Christopher Argent, MD, Principal investigator, Scientia Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181760
- Sponsor's protocol ID
- ISLA101-P01-CT001
- Status last verified
- Jan 2025
- First submitted
- 25 Oct 2023
- Last updated
- 27 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a, Randomized, Double-blind Placebo-controlled Study to Evaluate Safety and Tolerability and to Characterize the Pharmacokinetic Profile of Single Ascending Doses of Fenretinide Oral Capsules in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06181760
- Acronym / sponsor ID
- ISLA101-P01-CT001
- Conditions
- Safety and Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Island PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Beyond Drug Development
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 13 Feb 2024 (actual)
- First posted
- 26 Dec 2023 (actual)
- Results
- Posted 27 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial was to learn about a single dose of fenretinide in healthy volunteers, in both a fasted and fed state. The main questions to answer were:
- How well is a single dose of fenretinide tolerated? AND
- How is a single dose of fenretinide metabolized in healthy volunteers?
Participants will be asked to:
- Remain confined in a clinical research unit for 5 days after dosing.
- Provide blood samples for intense PK sampling and safety labs.
- Fast for 10 hours prior to administration of study drug (fasted cohorts).
- Consume a high fat meal prior to administration of study drug (fed cohort).
- Return to the clinic for a single follow-up visit for safety assessments.
The study will compare active fenretinide to placebo to see if fenretinide is more or less tolerable than placebo.
Detailed description
This study is a randomized, double-blind, placebo-controlled single ascending dose study. There are 3 planned dose-level cohorts (Cohorts 1-3). Each dose-level cohort will consist of 8 subjects (6 active + 2 placebo), who will be treated under fasted conditions. The subjects in the highest tolerated dose-level cohort (determined by the Safety Review Committee) will also be administered ISLA101 or placebo under fed conditions, in a cross-over manner (Cohort 4).
Proposed doses are 300, 600, and 900 mg/m^2 (equivalent to 8.1, 16.2, and 24.3 mg/kg). Each subject will be allocated to 1 dose level only.
The study will include a 5-day stay in the clinical research unit followed by a final safety follow-up visit at Day 8, where subjects will be under fasted conditions when they are dosed on Study Day 1.
For cohort 4, the study will again include a 5-day stay in the clinical research unit followed by a final safety follow-up visit at Day 17, where subjects will be under fed conditions when they are dosed on Study Day 10.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized, double-blind, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Fenretinide 300 mg/m^2 | Active comparator | Drug: FenretinideSingle oral dose of fenretinide, 300 mg/m^2 under fasted conditions (Phase 1) |
| Fenretinide 600 mg/m^2 | Active comparator | Drug: FenretinideSingle oral dose of fenretinide, 600 mg/m^2 under fasted conditions (Phase 1) Once all groups finish Phase 1, return to complete Phase 2 with a single oral dose of fenretinide, 600 mg/m^2 under fed conditions per recommendation from the independent Safety Review Committee. |
| Fenretinide 900 mg/m^2 | Active comparator | Drug: FenretinideSingle oral dose of fenretinide, 900 mg/m^2 under fasted conditions (Phase 1) |
| Placebo | Placebo comparator | Drug: PlaceboSingle oral dose of placebo capsules under fasted conditions (Phase 1) Once all groups finish Phase 1, return to complete Phase 2 with a single oral dose of placebo capsules under fed conditions per recommendation from the independent Safety Review Committee. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Healthy male or female volunteers not of childbearing potential, who are 18 years to 65 years of age (inclusive) at the time of signing the informed consent form (ICF).
- Females not of childbearing potential, as defined in the following criteria:
- Male subjects with female partners of childbearing potential must agree to practice abstinence or use a combination of 2 of the following acceptable birth control methods during the study and for at least 90 days after dosing:
- Must be able to understand and provide signed informed consent for study participation.
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (27 listed)
- Known or suspected pregnancy (confirmed via a positive serum human chorionic gonadotropin [hCG] pregnancy test at screening), planned pregnancy during the study period, nursing, or lactation.
- Women of childbearing potential or men who intend to father a child or donate sperm during the study period and for 3 months after study drug administration.
- Known allergy to fenretinide or any of the components of ISLA101.
- Evidence or history of clinically significant medical conditions, such as hematological, renal, endocrine (e.g., polycystic ovarian syndrome or other anovulatory states), immunologic, pulmonary, metabolic, gastrointestinal (e.g., Crohn's disease, acute or chronic pancreatitis, and others) and surgery (except for simple appendectomy or repair of a hernia), which all can influence the absorption of study drug; cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), or any other illness that the Investigator considers exclusionary or that could interfere with the interpretation of the study results.
- History of severe infectious disease or recurrent infections.
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 |
|---|---|---|
| FenretinideAscending single doses of oral fenretinide | Drug | Fenretinide 300 mg/m^2, Fenretinide 600 mg/m^2, Fenretinide 900 mg/m^2 |
| PlaceboSingle oral dose of matching placebo capsules | Drug | Placebo |
Primary outcome
Number and % of Subjects Experiencing Adverse Events Following a Single Oral Dose of Fenretinide Under Fasted Conditions
Time frame: First Intervention (Day 1 to Day 8)
Number and % of Subjects Experiencing Serious Adverse Events Following a Single Oral Dose of Fenretinide Under Fasted Conditions
Time frame: First Intervention (Day 1 to Day 8)
25 total subjects were enrolled in the study.
Number and % of Subjects Experiencing Adverse Events Following a Single Oral Dose of Fenretinide Under Fed Conditions
Time frame: Second Intervention (Day 9 to Day 17)
Subjects in the 600 mg/m^2 came back to complete the fed cohort, as this was the only group to return based on the recommendations by the Safety Review Committee. Only 4 out of the 6 subjects returned for this cohort (i.e., 3 subjects on ISLA101 and 1 subject on placebo).
Number and % of Subjects Experiencing Serious Adverse Events Following a Single Oral Dose of Fenretinide Under Fed Conditions
Time frame: Second Intervention (Day 9 to 17)
25 total subjects were enrolled in the study. After all fasted cohorts completed (i.e., 300 mg/m^2, 600 mg/m^2, 900 mg/m^2 as well as placebo) data was reviewed by the independent Safety Review Committee. The recommendation was to bring back the 600 mg/m^2 group to complete the fed cohort and only 4 out of the 6 subjects were available (i.e., 3 subjects on ISLA101 and 1 subject on placebo).
5 secondary outcomes
Assess the CMax - Observed Maximum Plasma Concentration Following a Single Oral Dose of Fenretinide
Time frame: First Intervention (Day 1 to Day 8), washout period, Second Intervention (Day 9-17)
Assess the TMax - Time to Reach Maximum Concentration Curve Following a Single Oral Dose of Fenretinide in the Fasted and Fed State
Time frame: First Intervention (Day 1 to Day 8), washout period, Second Intervention (Day 9-17)
Assess the AUC-∞ Area Under the Concentration Curve From Zero to Infinite Time Following a Single Oral Dose of Fenretinide in the Fasted and Fed State
Time frame: First Intervention (Day 1 to Day 8), washout period, Second Intervention (Day 9-17)
Assess the AUC(Last) - Area Under the Curve up to the Last Quantifiable Timepoint After a Single Oral Dose of Fenretinide in the Fasted and Fed State
Time frame: First Intervention (Day 1 to Day 8), washout period, Second Intervention (Day 9-17)
Assess the Half Life of a Single Oral Dose of Fenretinide in the Fasted and Fed State
Time frame: First Intervention (Day 1 to Day 8), washout period, Second Intervention (Day 9-17)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Safety and Tolerability
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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.
Christopher Argent, MD principal investigator
Scientia Clinical Research
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 Fenretinide in people with Safety and Tolerability, run by Island Pharmaceuticals at 1 site in Australia.
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 17 inclusion and 27 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 27 Jan 2025. 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 Australia. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 27 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number and % of Subjects Experiencing Adverse Events Following a Single Oral Dose of Fenretinide Under Fasted Conditions (time frame: First Intervention (Day 1 to Day 8)). The study lists 4 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 27 Jan 2025.