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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01692184

Run by

Celgene

People needed

54

Starts

2012-08-01

Expected to finish

2012-10-08

Last updated by the study team

2019-11-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male or female subjects of any ethnic origin between ages of 18 and 65 with a body mass index between 18 and 33

You may not qualify if…

• Recent history (i.e., within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine, hematological, dermatological, psychological, ophthalmological, allergic or other major disorders;
• Use of any prescribed systemic or topical medication within 30 days of the first dose;
• Use of any non-prescribed systemic or topical medication (including vitamin/mineral supplements and herbal medicines, e.g., St. John's Wort) within 7 days of the first dose administration;
• Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration

Where it is running

• Covance Clinical Research Unit — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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