NCT06145607

A Phase 1 Study Assessing the Effect of Food on the Pharmacokinetics of ABBV- CLS-7262

A Phase 1 Study to Evaluate Safety, Tolerability, and Food-Effect Following Administration of ABBV-CLS-7262 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Calico Life Sciences LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, three period, six sequence, single dose crossover design with ABBV-CLS-7262 in healthy adult subjects.

Detailed description

On Day 1 of each period, subjects will receive a single oral dose of ABBV-CLS-7262 administered according to the food regimen assigned. There will be a 4-day washout period between doses. Food regimens include administration after fasting, following a high-fat/high-calorie meal, or with apple sauce. Upon completion each subject will have taken a total of three doses of ABBV-CLS-7262, with one dose administered with each food regimen.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ABBV-CLS-7262	ABBV-CLS-7262

Timeline

• Start date: 2023-12-19
• Primary completion: 2024-01-30
• Completion: 2024-02-26
• First posted: 2023-11-24
• Last updated: 2024-03-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study