A PK Study of IkT-148009 in Older and Elderly Healthy Subjects

Completed · Phase 1

Conditions studied: Healthy

In brief

This is a two-part study. Part A consists of two different IkT-148009-201 solid dosage formulations that are being evaluated to determine their steady-state pharmacokinetic profile. Part B is a drug-drug interaction (DDI) study focused on evaluating the impact of a strong CYP3A inhibitor on the preferred dosage determined in part A.

Key facts

Study ID: NCT06644326
Run by: ABLi Therapeutics, Inc.
People needed: 8
Starts: 2023-06-21
Expected to finish: 2024-08-27
Last updated by the study team: 2024-10-16

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Subject must have all questions about the study answered and must have signed the informed consent document before any study-specific procedures are performed.
Healthy ambulatory male and female subjects with no history or evidence of clinically relevant medical disorders as determined by the Investigator in consultation with the Sponsor.
Bodyweight > 50 kg and body mass index (BMI) > 18.0 and < 32.0 kg/m2.
Physical examination, clinical laboratory values, vital signs, and electrocardiogram (ECG) data.
Female subjects must be postmenopausal, permanently sterile (bilateral tubal occlusion), or of childbearing potential with a negative pregnancy test, non-breastfeeding, and using two highly effective methods of birth control.
Male subjects must agree to practice an acceptable method of highly effective birth control.
Males must be willing to abstain from sperm donation from the screening visit, while on study and through 30 days after receiving the last dose of study drug.

You may not qualify if…

Any subject with previous exposure to imatinib or known hypersensitivity to imatinib.
Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at the screening and admission visits.
Clinically significant abnormal physical examination or 12-lead electrocardiogram (ECG) at the screening or admission visits.
Clinically significant abnormal renal function.
Significant history (within six months prior to receiving the study drug) and/or presence of hepatic, renal, cardiovascular, pulmonary, gastrointestinal, endocrinological, hematological, dermatological, psychiatric, neurological, immunologic, ophthalmologic, metabolic, fluid retention and edema, bleeding disorders including hemorrhage or oncological disease.
Any subject with a history, presence and/or current evidence of serologic positive result for hepatitis B surface antigen, hepatitis C antibodies, or HIV antibodies 1 or 2.
Recent history (within previous six months prior to screening) of alcohol or drug abuse (as judged by the investigator), or has consumed > 2 alcohol drinks/day during the last three months prior to screening.
Any subject who currently uses or has regularly used tobacco or tobacco-containing products (cigarettes, pipes, etc.) for at least 30 days prior to screening or positive urine cotinine screen at the screening or admission visits.
Any subject who has received treatment with an investigational drug during the 30 days prior to screening. Exposure to an investigational medical device within 30 days of screening.
Use of agents known to affect drug metabolism: use of any known CYP3A4 inducers and/or inhibitors or consumed grapefruit juice, grapefruit, Seville oranges or St John's Wort or products containing these within 14 days prior to first administration of study drug. Strong inducers of CYP3A4 include dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifampicin and phenobarbital. Strong inhibitors of CYP3A4 include ketoconazole, itroconazole, clarythromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole.
Investigative site personnel or their immediate families (spouse, parent, child or sibling whether biological or legally adopted).
Any subject unwilling or unable to comply with study procedures.
Pregnant or nursing women.
Anyone who does not meet the requirements for exclusion of certain concomitant medications as defined in Section 7.5.

Where it is running

Celerion — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.