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

NCT06644326 | Completed Phase 1 FDA Drug

• 1 other identifier: IkT-148009-103
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (11)

• Patient Safety

  Changes in vital sign measurements including HR and blood pressure.

  Through study completion, an average of 17 days

• Patient Safety

  Changes in clinical laboratory data consisting of CBC, Serum Chemistry, FSH

  Through study completion, an average of 17 days

• Patient Safety

  Electrocardiogram \[ECG\] parameters of ventricular rate, RR or PR interval, QRS complex, and QTcF interval.

  Through study completion, an average of 17 days

• Patient Safety

  C-SSRS assessment values.

  Through study completion, an average of 17 days

• Pharmacokinetic parameters in the absence or presence of itraconazole:

  Pharmacokinetic parameters: • Area under the concentration-time curve from time zero to 96 hours (AUC0-∞)

  Through study completion, an average of 17 days

• Pharmacokinetic parameters in the absence or presence of itraconazole:

  Pharmacokinetic parameters: • Maximum plasma concentration (Cmax)

  Through study completion, an average of 17 days

• Pharmacokinetic parameters in the absence or presence of itraconazole:

  Pharmacokinetic parameters: • Area under the concentration-time curve from time zero to last time point (AUC0-last)

  Through study completion, an average of 17 days

• Assess the pharmacokinetics (PK) of IkT-148009

  Pharmacokinetic parameters: • Area under the concentration-time curve from time zero to 96 hours (AUC0-∞)

  Through study completion, an average of 17 days

• Assess the pharmacokinetics (PK) of IkT-148009

  Pharmacokinetic parameters: • Maximum plasma concentration (Cmax)

  Through study completion, an average of 17 days

• Assess the pharmacokinetics (PK) of IkT-148009

  Pharmacokinetic parameters: • Area under the concentration-time curve from time zero to last time point (AUC0-last)

  Through study completion, an average of 17 days

• Patient Tolerability

  Adverse event reporting

  Through study completion, an average of 17 days

Study Arms (2)

Part A IkT-148009 Dry/Wet

ACTIVE COMPARATOR

100mg IkT-148009 Wet \& 100mg IkT-148009 Dry

Drug: 100mg IkT-148009 Wet; Drug: 100mg IkT-148009 Dry

Part B - Ikt-148009 wet/ Itraconazole

ACTIVE COMPARATOR

200 mg Itraconazole \& 50mg IkT-148009 Wet

Drug: 200 mg Itraconazole; Drug: 50mg IkT-148009 Wet

Interventions

100mg IkT-148009 Wet DRUG

100mg wet tablet formulation

Part A IkT-148009 Dry/Wet

200 mg Itraconazole DRUG

2 100mg capsules

Part B - Ikt-148009 wet/ Itraconazole

100mg IkT-148009 Dry DRUG

100mg dry tablet formulation

Part A IkT-148009 Dry/Wet

50mg IkT-148009 Wet DRUG

50mg wet tablet formulation

Part B - Ikt-148009 wet/ Itraconazole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• ABLi Therapeutics, Inc.: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: October 16, 2024
• Study Start: June 21, 2023
• Primary Completion: August 17, 2024
• Study Completion: August 27, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)