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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01692184
First received: September 21, 2012
Last updated: October 5, 2012
Last verified: October 2012
  Purpose

This is a 2-part study. The first part is to evaluate the safety, pharmacokinetics 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.


Condition Intervention Phase
Healthy
Drug: 50 mg of AVL-292
Drug: 100 mg of AVL-292
Drug: 200 mg of AVL-292
Drug: 350 mg of AVL-292
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: 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

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Up to 28 days after last AVL-292 dose ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events

  • PK-(Cmax) [ Time Frame: 24 hours after the last AVL-292 dose on days 1 and 7 ] [ Designated as safety issue: No ]
    Maximum observed concentration in plasma

  • PK-(AUC) [ Time Frame: 24 hours after the last AVL-292 dose days 1 and 7 ] [ Designated as safety issue: No ]
    Area under the plasma concentration-time curve


Secondary Outcome Measures:
  • Pharmacodynamic response measured in percentage of target occupancy by AVL-292 in peripheral blood mononuclear cells [ Time Frame: 24 hours after the last AVL-292 dose days 1 and 7 ] [ Designated as safety issue: No ]
    Pharmacodynamic response measured in percentage of target occupancy by AVL-292 in peripheral blood mononuclear cells


Estimated Enrollment: 54
Study Start Date: August 2012
Estimated Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 50 mg of AVL-292 and Placebo
50 mg AVL-292
Drug: 50 mg of AVL-292
50 mg AVL-292 (2X 25 mg AVL-292 capsules and 6 placebo capsules) once daily for 7 days administered orally under fasted condition
Other Name: AVL-292
Drug: Placebo
Experimental: 100 mg of AVL-292 and Placebo
100 mg AVL-292
Drug: 100 mg of AVL-292
100 mg AVL-292 (4X 25 mg AVL-292 capsules and 4 placebo capsules) once daily for 7 days administered orally under fasted condition
Other Name: AVL-292
Drug: Placebo
Experimental: 200 mg of AVL-292 and Placebo
200 mg AVL-292
Drug: 200 mg of AVL-292
200 mg AVL-292 (8X 25 mg AVL-292 capsules and 8 placebo capsules) once daily for 7 days administered orally under fasted condition.
Other Name: AVL-292
Drug: Placebo
Experimental: 350 mg of AVL-292 and Placebo
350 mg AVL-292
Drug: 350 mg of AVL-292
350 mg AVL-292 (14X 25 mg AVL-292 capsules and 14 placebo capsules) once daily for 7 days administered orally under fasted condition
Other Name: AVL-292
Drug: Placebo
Placebo Comparator: Placebo
Placebo
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692184

Locations
United States, Texas
Covance Clinical Research Unit
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Maria Palmisano, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01692184     History of Changes
Other Study ID Numbers: AVL-292-004
Study First Received: September 21, 2012
Last Updated: October 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
AVL-292
Safety
Pharmacokinetics
Pharmacodynamics
Pharmacology, Clinical

ClinicalTrials.gov processed this record on August 20, 2014