NCT01692184

Safety and Pharmacokinetics of AVL-292 Following Multiple Doses and the Effect of Food on the Single-dose Pharmacokinetics of AVL-292

A Phase 1, Two-part Study to Investigate the Safety and Pharmacokinetics of AVL-292 Following Multiple Oral Doses and to Evaluate the Effect of Food on the Pharmacokinetics of AVL-292 Following a Single Oral Dose in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a 2-part study. The first part is to evaluate the safety, pharmacokinetics (PK) and pharmacodynamics of AVL-292 following multiple oral doses; and the second part is to evaluate the effect of food on the pharmacokinetics of a single oral dose of AVL-292.

Detailed description

Part 2 is an open-label, randomized, 2-period, 2-way crossover study to evaluate the effect of a standard high-fat breakfast on the pharmacokinetics of AVL-292. Ten subjects will be enrolled to receive 2 single doses of 200 mg AVL-292, one with food (i.e., fed) and the other without (i.e., fasted), in a randomized sequence.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	50 mg AVL-292
DRUG	100 mg AVL-292
DRUG	200 mg AVL-292
DRUG	350 mg AVL-292
DRUG	Placebo capsules

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-10-08
• Completion: 2012-10-08
• First posted: 2012-09-25
• Last updated: 2019-11-04

Locations

1 site across 1 country: United States