NCT06641557

A Phase I Dosing Study of IkT-148009.

A Phase I, 7-Day Dosing Study of 200 Mg IkT-148009 to Determine the Safety, Tolerability and Pharmacokinetics (PK) of IkT-148009 in Older Adult and Elderly Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: ABLi Therapeutics, Inc. · Industry
• Sex: All
• Age: 45 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1 study in older adult or elderly healthy volunteer subjects to measure the safety, tolerability and pharmacokinetic (PK) profile of IkT-148009 capsules given as multiple capsules.

Detailed description

This is a Phase 1 study in older adult or elderly healthy volunteer subjects to measure the safety, tolerability and pharmacokinetic (PK) profile of IkT-148009 capsules given as multiple capsules. This is a single arm study with subjects to treatment with IkT-148009 only. The study will consist of a total of up to 15 visits over a period of up to 29 days prior to dosing, 7 days of dosing and 14 days of follow up. Subjects will receive a single daily dose of study drug with a meal for a period of up to 7 days. A full breakfast must be consumed prior to receiving the dose study drug. Subjects will be confined to the unit for approximately 12 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	200mg of Ikt-148009	4 50mg capsules

Timeline

• Start date: 2023-02-21
• Primary completion: 2023-03-21
• Completion: 2023-04-19
• First posted: 2024-10-15
• Last updated: 2025-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study