HealthyPhase 1NCT05027568
A Study to Assess an ATX Inhibitor (IOA-289) in Healthy Volunteers
A Phase 1 study testing IOA-289 and Nab paclitaxel / gemcitabine in people with Healthy, run by iOnctura at 1 site in Italy.
Trial summary
The purpose of Part 1 of this First-in-Human trial is to evaluate the safety and tolerability after single ascending oral doses of IOA-289 given to healthy male subjects, compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IOA-289 and Nab paclitaxel / gemcitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 28 Jun 2021to 7 Sep 2021
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between 18 and 50 years of age (inclusive) at the screening visit
- Body mass index between 18.0 and 30.0 kg/m2 (inclusive) at the screening visit
- In good health as determined by medical history, physical examination, ECG, serum/urine, clinical chemistry, haematology, and serology tests
- Able to provide written, informed consent prior to initiation of any trial-related procedures, and able, in the opinion of the Principal Investigator, to comply with all the requirements of the trial
- Male subjects who are surgically sterile (i.e., have undergone bilateral orchidectomy); and male subjects who agree to remain abstinent or to practice double-barrier forms of birth control and refrain from sperm donation from trial screening through 90 days from the last dose of IMP
Who cannot join
- Clinically significant abnormality in past medical history, or at the screening physical examination, that in the Investigator's or Sponsor's opinion may place the subject at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of IMP
- History of drug and/or alcohol abuse within 2 years prior to the screening visit
- History of or current hepatitis or acquired immunodeficiency syndrome or carriers of HBsAg, anti-HCV, and/or HIV antibodies
- History of any significant drug allergy
- Positive alcohol breath test and/or urine drug screen for substance of abuse at the screening visit or upon check-in to the clinical trial site
- History of having taken an investigational drug within 30 days preceding trial entry
Show all 13Show fewer
- History of significant bleeding or haemorrhagic tendencies
- Donation of blood or plasma within 30 days prior to dosing
- Use of prescription medication, over-the-counter medication, herbal medication, or vitamin supplements within 14 days prior to dosing and antibiotics within 30 days prior to dosing. The Sponsor may allow exceptions only if the medication's administration is deemed unlikely to impact the PK result
- Exposure to any substances known to stimulate hepatic microsomal enzymes within 30 days prior to screening (e.g., occupational exposure to pesticides, organic solvents)
- Supine blood pressure, after resting for ≥3 minutes, higher than 140/90 mmHg or lower than 100/50 mmHg. The Sponsor may allow exceptions if they are not deemed clinically significant
- Supine pulse rate, after resting for ≥3 minutes, outside the range of 50 to 90 bpm. The Sponsor may allow exceptions if they are not deemed clinically significant
- History of serious mental disorders that, in the opinion of the Investigator, would exclude the subject from participating in this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Dose Escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of IOA-289 in Healthy Male Volunteers
The purpose of Part 1 of this First-in-Human trial is to evaluate the safety and tolerability after single ascending oral doses of IOA-289 given to healthy male subjects, compared to placebo. After the oral dose administrations, the amount of IOA-289 present in serum will be determined for pharmacokinetic characterisation. Also the reduction of LPA in plasma will be determined as a pharmacodynamic biomarker.
Part 2 is optional and its conduct will be dependent on the pharmacokinetic data generated in Part 1. Part 2 will be a randomized, crossover, open label, single oral dose administration of IOA-289 to healthy male subjects either in a fasted state, or after a high-fat meal.
- Conditions
- Healthy
- Being tested
- IOA-289, Nab paclitaxel / gemcitabine
- Keywords
- Healthy subjects, effect of food, Roginolisib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOA-289Drug
Daily oral twice daily dosing of IOA-289
Nab paclitaxel / gemcitabineDrug
Given in combination with IOA-289
| Study group | Role | What they receive |
|---|---|---|
| IOA-289 daily oral dosing plus gemcitabine and nabpaclitaxel every 3 weeks starting on Day 8 | Experimental | Not described Receives: Drug: IOA-289; Drug: Nab paclitaxel / gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of participants with treatment-related adverse events as assessed by MedDRA v24
Adverse Events will be assessed by nondirective questioning of the participants during the screening process and at each visit during the study
Measured: Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
Secondary outcomes (5)
Pharmacokinetic profile of IOA-289
Blood samples for plasma IOA-289 concentrations
Measured: Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
Cmax
The maximum observed plasma concentration
Measured: Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
Tmax
The time at which Cmax occurs
Measured: Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
AUCinf
The area under the plasma concentration-time curve from time of dosing to infinity
Measured: Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
To determine the change from baseline of LPA levels
Measurement of LPA levels in plasma
Measured: Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start28 Jun 2021
- Primary completion7 Sep 2021
- Study completion7 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- iOnctura
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027568
- Sponsor's protocol ID
- IOA-289-101
- Status last verified
- Mar 2025
- First submitted
- 16 Jul 2021
- Last updated
- 20 Mar 2025
- 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 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Dose Escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of IOA-289 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT05027568
- Acronym / sponsor ID
- IOA-289-101
- Conditions
- Healthy
- Keywords
- Healthy subjects, effect of food, Roginolisib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- iOncturaIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 30 Aug 2021 (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.
The purpose of Part 1 of this First-in-Human trial is to evaluate the safety and tolerability after single ascending oral doses of IOA-289 given to healthy male subjects, compared to placebo. After the oral dose administrations, the amount of IOA-289 present in serum will be determined for pharmacokinetic characterisation. Also the reduction of LPA in plasma will be determined as a pharmacodynamic biomarker.
Part 2 is optional and its conduct will be dependent on the pharmacokinetic data generated in Part 1. Part 2 will be a randomized, crossover, open label, single oral dose administration of IOA-289 to healthy male subjects either in a fasted state, or after a high-fat meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IOA-289 daily oral dosing plus gemcitabine and nabpaclitaxel every 3 weeks starting on Day 8 | Experimental | Drug: IOA-289, Drug: Nab paclitaxel / gemcitabine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subjects between 18 and 50 years of age (inclusive) at the screening visit
- Body mass index between 18.0 and 30.0 kg/m2 (inclusive) at the screening visit
- In good health as determined by medical history, physical examination, ECG, serum/urine, clinical chemistry, haematology, and serology tests
- Able to provide written, informed consent prior to initiation of any trial-related procedures, and able, in the opinion of the Principal Investigator, to comply with all the requirements of the trial
- Male subjects who are surgically sterile (i.e., have undergone bilateral orchidectomy); and male subjects who agree to remain abstinent or to practice double-barrier forms of birth control and refrain from sperm donation from trial screening through 90 days from the last dose of IMP
Key exclusion criteria (13 listed)
- Clinically significant abnormality in past medical history, or at the screening physical examination, that in the Investigator's or Sponsor's opinion may place the subject at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of IMP
- History of drug and/or alcohol abuse within 2 years prior to the screening visit
- History of or current hepatitis or acquired immunodeficiency syndrome or carriers of HBsAg, anti-HCV, and/or HIV antibodies
- History of any significant drug allergy
- Positive alcohol breath test and/or urine drug screen for substance of abuse at the screening visit or upon check-in to the clinical trial site
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 |
|---|---|---|
| IOA-289Daily oral twice daily dosing of IOA-289 | Drug | IOA-289 daily oral dosing plus gemcitabine and nabpaclitaxel every 3 weeks starting on Day 8 |
| Nab paclitaxel / gemcitabineGiven in combination with IOA-289 | Drug | IOA-289 daily oral dosing plus gemcitabine and nabpaclitaxel every 3 weeks starting on Day 8 |
Primary outcome
Numbers of participants with treatment-related adverse events as assessed by MedDRA v24
Time frame: Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
Adverse Events will be assessed by nondirective questioning of the participants during the screening process and at each visit during the study
5 secondary outcomes
Pharmacokinetic profile of IOA-289
Time frame: Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
Cmax
Time frame: Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
Tmax
Time frame: Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
AUCinf
Time frame: Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
To determine the change from baseline of LPA levels
Time frame: Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
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 20 Mar 2025.
- 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 IOA-289 and Nab paclitaxel / gemcitabine in people with Healthy, run by iOnctura at 1 site in Italy.
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 13 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 20 Mar 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 Italy. 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?
Numbers of participants with treatment-related adverse events as assessed by MedDRA v24 (time frame: Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose). 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 20 Mar 2025.