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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01692184
First Posted: September 25, 2012
Last Update Posted: March 25, 2016
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.
Information provided by (Responsible Party):
Celgene Corporation
  Purpose
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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


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 ]
    Pharmacodynamic response measured in percentage of target occupancy by AVL-292 in peripheral blood mononuclear cells


Estimated Enrollment: 54
Study Start Date: August 2012
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 (2 x 25 mg AVL-292 capsules and 6 placebo capsules) once daily for 7 days administered orally under fasted condition
Drug: 50 mg AVL-292
Other Name: 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
Drug: 100 mg AVL-292
Other Name: 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
Drug: 200 mg AVL-292
Other Name: 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
Drug: 350 mg AVL-292
Other Name: AVL-292
Placebo Comparator: Placebo - 8 capsules
8 placebo capsules once daily for 7 days administered orally under fasted condition
Drug: Placebo capsules
Placebo Comparator: Placebo - 14 capsules
14 placebo capsules once daily for 7 days administered orally under fasted condition
Drug: Placebo capsules

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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01692184     History of Changes
Other Study ID Numbers: AVL-292-004
First Submitted: September 21, 2012
First Posted: September 25, 2012
Last Update Posted: March 25, 2016
Last Verified: March 2016

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