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

Celgene

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo capsules; Drug: 350 mg AVL-292; Drug: 50 mg AVL-292; Drug: 100 mg AVL-292; Drug: 200 mg AVL-292

Study type: Interventional

Funder types: Industry

Identifiers

NCT01692184

AVL-292-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

54 participants in 6 patient groups, including a placebo group

50 mg of AVL-292 and Placebo

Experimental group

Description:

50 mg AVL-292 (2 x 25 mg AVL-292 capsules and 6 placebo capsules) once daily for 7 days administered orally under fasted condition

Treatment:

Drug: 50 mg AVL-292

Drug: Placebo capsules

100 mg of AVL-292 and Placebo

Experimental group

Description:

100 mg AVL-292 (4 x 25 mg AVL-292 capsules and 4 placebo capsules) once daily for 7 days administered orally under fasted condition

Treatment:

Drug: 100 mg AVL-292

Drug: Placebo capsules

200 mg AVL-292

Experimental group

Description:

8 x 25 mg AVL-292 capsules orally once daily for 7 days under fasted condition

Treatment:

Drug: 200 mg AVL-292

350 mg of AVL-292

Experimental group

Description:

350 mg AVL-292 (14 x 25 mg AVL-292 capsules) once daily for 7 days administered orally under fasted condition

Treatment:

Drug: 350 mg AVL-292

Placebo - 8 capsules

Placebo Comparator group

Description:

8 placebo capsules once daily for 7 days administered orally under fasted condition

Treatment:

Drug: Placebo capsules

Placebo - 14 capsules

Placebo Comparator group

Description:

14 placebo capsules once daily for 7 days administered orally under fasted condition

Treatment:

Drug: Placebo capsules