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
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 April 16, 2014