Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01692184
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date  ICMJE September 21, 2012
First Posted Date  ICMJE September 25, 2012
Last Update Posted Date November 4, 2019
Actual Study Start Date  ICMJE August 1, 2012
Actual Primary Completion Date October 8, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2012)
  • Adverse Events [ Time Frame: Up to 28 days after last AVL-292 dose ]
    Number of participants with adverse events
  • PK-(Cmax) [ Time Frame: 24 hours after the last AVL-292 dose on days 1 and 7 ]
    Maximum observed concentration in plasma
  • PK-(AUC) [ Time Frame: 24 hours after the last AVL-292 dose days 1 and 7 ]
    Area under the plasma concentration-time curve
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2012)
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 ]
Pharmacodynamic response measured in percentage of target occupancy by AVL-292 in peripheral blood mononuclear cells
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Pharmacokinetics of AVL-292 Following Multiple Doses and the Effect of Food on the Single-dose Pharmacokinetics of AVL-292
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: 50 mg AVL-292
    Other Name: AVL-292
  • Drug: 100 mg AVL-292
    Other Name: AVL-292
  • Drug: 200 mg AVL-292
    Other Name: AVL-292
  • Drug: 350 mg AVL-292
    Other Name: AVL-292
  • Drug: Placebo capsules
Study Arms  ICMJE
  • Experimental: 50 mg of AVL-292 and Placebo
    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
    Interventions:
    • Drug: 50 mg AVL-292
    • Drug: Placebo capsules
  • Experimental: 100 mg of AVL-292 and Placebo
    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
    Interventions:
    • Drug: 100 mg AVL-292
    • Drug: Placebo capsules
  • Experimental: 200 mg AVL-292
    8 x 25 mg AVL-292 capsules orally once daily for 7 days under fasted condition
    Intervention: Drug: 200 mg AVL-292
  • Experimental: 350 mg of AVL-292
    350 mg AVL-292 (14 x 25 mg AVL-292 capsules) once daily for 7 days administered orally under fasted condition
    Intervention: Drug: 350 mg AVL-292
  • Placebo Comparator: Placebo - 8 capsules
    8 placebo capsules once daily for 7 days administered orally under fasted condition
    Intervention: Drug: Placebo capsules
  • Placebo Comparator: Placebo - 14 capsules
    14 placebo capsules once daily for 7 days administered orally under fasted condition
    Intervention: Drug: Placebo capsules
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 24, 2012)
54
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 8, 2012
Actual Primary Completion Date October 8, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01692184
Other Study ID Numbers  ICMJE AVL-292-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celgene
Study Sponsor  ICMJE Celgene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Maria Palmisano, MD Celgene Corporation
PRS Account Celgene
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP