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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05027568
Other study ID # IOA-289-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 5, 2021
Est. completion date December 20, 2021

Study information

Verified date October 2022
Source iOnctura
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 20, 2021
Est. primary completion date September 7, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Single ascending doses of IOA-289
Single dose, oral administration of liquid-filled capsules, with a starting dose of 30 mg
Placebo single doses
Single dose, oral administration of liquid-filled capsules, matching placebo

Locations

Country Name City State
Italy Centro Ricerche Cliniche di Verona srl Verona

Sponsors (1)

Lead Sponsor Collaborator
iOnctura

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
Secondary Pharmacokinetic profile of IOA-289 Blood samples for plasma IOA-289 concentrations Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
Secondary Cmax The maximum observed plasma concentration Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
Secondary Tmax The time at which Cmax occurs Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
Secondary AUCinf The area under the plasma concentration-time curve from time of dosing to infinity Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
Secondary To determine the change from baseline of LPA levels Measurement of LPA levels in plasma Day 1: Predose and at 0.5,1, 2, 4, 8, 10 and 24 hours postdose
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