A Study to Assess an ATX Inhibitor (IOA-289) in Healthy Volunteers

iOnctura

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: IOA-289

Drug: Nab paclitaxel / gemcitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT05027568

IOA-289-101

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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