NCT06644326

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

A Pharmacokinetic Bridging Study of Film-Coated Tablets of IkT-148009 in Older and Elderly Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: ABLi Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a two-part study. Part A is a single dose (7-day) study to determine the safety, tolerability and pharmacokinetics (PK) of two different tablet formulations of IkT-148009 in older and elderly healthy subjects. Subjects in each cohort of the study will be admitted to the unit the day prior to the expected day of dosing and will be confined to the unit for approximately 12 days. Each cohort will consist of six (6) subjects who will receive treatment with one of two formulations of IkT- 148009 film-coated tablets at a single dose once daily for 7 days. Part B is a Drug-Drug Interaction (DDI) study to determine the effect of itraconazole on the pharmacokinetics of IkT-148009. Subjects in each cohort of the study will be admitted to the unit the day prior to the expected day of dosing in each period and will be confined to the unit for approximately 6 days in period 1 and 10 days in period 2. Up to eight (8) subjects will be evaluated in a two-period design in the fed state. In Period 1, the 50 mg film-coated IkT-148009 tablet dose pharmacokinetics will be measured, followed by a 7-day washout. In Period 2, the same eight subjects will first be administered a 200 mg once daily capsule dose of itraconazole for four days. On Period 2 day 4 subjects will take a single 200 mg capsule dose of itraconazole, followed one hour later by a 50 mg film-coated tablet dose of IkT-148009.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	100mg IkT-148009 Wet	100mg wet tablet formulation
DRUG	200 mg Itraconazole	2 100mg capsules
DRUG	100mg IkT-148009 Dry	100mg dry tablet formulation
DRUG	50mg IkT-148009 Wet	50mg wet tablet formulation

Timeline

• Start date: 2023-06-21
• Primary completion: 2024-08-17
• Completion: 2024-08-27
• First posted: 2024-10-16
• Last updated: 2024-10-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study