Safety and Pharmacokinetics of AVL-292 Following Multiple Doses and the Effect of Food on the Single-dose Pharmacokinetics of AVL-292
- Conditions
- Healthy
- Interventions
- Drug: 50 mg AVL-292Drug: 100 mg AVL-292Drug: 200 mg AVL-292Drug: 350 mg AVL-292Drug: Placebo capsules
- Registration Number
- NCT01692184
- Lead Sponsor
- Celgene
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- Healthy male or female subjects of any ethnic origin between ages of 18 and 65 with a body mass index between 18 and 33
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 50 mg of AVL-292 and Placebo 50 mg AVL-292 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 50 mg of AVL-292 and Placebo Placebo capsules 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 100 mg of AVL-292 and Placebo Placebo capsules 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 Placebo - 8 capsules Placebo capsules 8 placebo capsules once daily for 7 days administered orally under fasted condition Placebo - 14 capsules Placebo capsules 14 placebo capsules once daily for 7 days administered orally under fasted condition 100 mg of AVL-292 and Placebo 100 mg AVL-292 100 mg AVL-292 (4 x 25 mg AVL-292 capsules and 4 placebo capsules) once daily for 7 days administered orally under fasted condition 200 mg AVL-292 200 mg AVL-292 8 x 25 mg AVL-292 capsules orally once daily for 7 days under fasted condition 350 mg of AVL-292 350 mg AVL-292 350 mg AVL-292 (14 x 25 mg AVL-292 capsules) once daily for 7 days administered orally under fasted condition
- Primary Outcome Measures
Name Time Method Adverse Events Up to 28 days after last AVL-292 dose Number of participants with adverse events
PK-(Cmax) 24 hours after the last AVL-292 dose on days 1 and 7 Maximum observed concentration in plasma
PK-(AUC) 24 hours after the last AVL-292 dose days 1 and 7 Area under the plasma concentration-time curve
- Secondary Outcome Measures
Name Time Method Pharmacodynamic response measured in percentage of target occupancy by AVL-292 in peripheral blood mononuclear cells 24 hours after the last AVL-292 dose days 1 and 7 Pharmacodynamic response measured in percentage of target occupancy by AVL-292 in peripheral blood mononuclear cells
Trial Locations
- Locations (1)
Covance Clinical Research Unit
🇺🇸Dallas, Texas, United States