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Study to Assess Safety, Tolerability, and Pharmacokinetics of Oral Doses for AC430 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ambit Biosciences Corporation
ClinicalTrials.gov Identifier:
NCT01287858
First received: January 12, 2011
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

AC430 will be administered, orally under fasting conditions (fasting 4 hours before and 2 hours after dosing) with approximately 240 mL of water either once daily or twice daily. It is designed to assess the safety, tolerability, and pharmacokinetics of single and multiple oral doses of AC430.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: AC430
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double Blind, Placebo Controlled, Sequential, Ascending Single-Dose and Multiple-Dose First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AC430 in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Ambit Biosciences Corporation:

Primary Outcome Measures:
  • Assess the safety, tolerability, and pharmacokinetics of single and multiple oral doses of AC430. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    • Number of participants with adverse events as measurement of safety and tolerability of AC430. [Time frame: 1-28 days]
    • Maximum concentration (Cmax) for AC430 in plasma (measured in ng/mL) [Time frame: 1-28 days]
    • Tmax = Time of maximum concentration of AC430 in plasma (hr) [Time frame: 1-28 days]
    • AUC = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL) [Time frame: 1-28 days]
    • Urine: amount of AC430 excreted in urine (Ae0-48), renal clearance (CLr) and fraction of drug excreted in urine (Fe). [Time frame: 1-28 days]


Secondary Outcome Measures:
  • Determine the pharmacodynamic effects of single and multiple oral doses of AC430. [ Time Frame: Measured at specific timepoints prior to and following dosing regimen. ] [ Designated as safety issue: No ]
    • Single ascending dose (SAD): Pharmacodynamics (blood analysis) of AC430 [Time Frame: up to 8 days post dose] [Designated as safety issue: No]
    • Multiple ascending doses (MAD): Pharmacodynamics (blood analysis) of AC430 [Time Frame: up to 17 days postdose] [Designated as safety issue: No]


Enrollment: 88
Study Start Date: November 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: AC430
Healthy volunteers will either receive AC430 or placebo.
Other Name: AC430
Active Comparator: AC430
AC430
Drug: AC430
Healthy volunteers will either receive AC430 or placebo.
Other Name: AC430

Detailed Description:

A dose-finding study of AC430 in healthy volunteers.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Important Inclusion Criteria:

  1. Healthy normal males and females, age 18 to 45, inclusive, at the time of consent
  2. Able to communicate effectively in the English language
  3. Able to provide valid, written informed consent
  4. Able to swallow up to 20 capsules of study drug
  5. BMI (body mass index) ranging between 18 and 30 kg/m2, inclusive
  6. Minimum weight of 50 kg
  7. Serum Creatinine ≤ ULN (upper limit of normal) and estimated creatinine clearance at screening of ≥ 80 mL/min per the Cockcroft-Gault equation
  8. Total serum bilirubin ≤ ULN (may be repeated to confirm eligibility)
  9. Serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ ULN (may be repeated to confirm eligibility)
  10. Male subjects must either be sterile or agree to use from Check-in until 90 days following the last dose of AC430, an acceptable form of birth control.
  11. Female participants must be either of non-child-bearing potential or agree to use an acceptable form of birth control.

Important Exclusion Criteria:

  1. History of clinically significant drug allergy
  2. Participation in another clinical trial with receipt of an Investigational Product within 90 days before dose administration (or 5 half-lives, whichever is longer)
  3. Major surgery within 90 days before study enrollment
  4. Use of prescription, over the counter, or herbal medications or supplements, including oral contraceptives within 14 days of check-in
  5. A history of drug abuse or a history of alcohol abuse within 1 year prior to Screening
  6. Current or recent (within 30 days before enrollment) use of tobacco or nicotine products
  7. Consumption of alcohol containing beverages > an average of 14 drinks per week or unwillingness to refrain from ethanol consumption while confined to the study unit
  8. Inadequate venous access that would interfere with obtaining blood samples
  9. Recipients of blood transfusion or transfusion of blood or plasma products, within 90 days before study drug administration
  10. Donation of blood ≥ 500 mL within 2 months before study drug administration
  11. History or positive laboratory evidence of Human immunodeficiency virus (HIV), Hepatitis B antigen and antibody, or Hepatitis C, or history of Tuberculosis (TB) infection, or a positive result for Quantiferon Gold test
  12. Prolonged average of the corrected QTc by Fridericia's correction factor (QTcF) interval on screening electrocardiogram (ECG) triplicate (≥ 450 ms for males and ≥ 470 ms for females)
  13. Abnormal laboratory values that are considered clinically significant by the Investigator
  14. History of cancer
  15. History of eating disorders within the past 3 months
  16. History of a seizure disorder or clinically significant head injury
  17. Positive urine drug screen for drugs of abuse including alcohol
  18. Active infection within 90 days of check-in
  19. Medical condition, serious intercurrent illness, cardiovascular, pulmonary, neurologic, psychiatric, renal, hepatic or gastrointestinal disease, or other extenuating circumstance that, in the judgment of the Principal Investigator, could jeopardize subject safety or interfere with the objectives of the study
  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: NCT01287858

Locations
United States, Wisconsin
Covance Clinical Research Unit
Madison, Wisconsin, United States, 53718
Sponsors and Collaborators
Ambit Biosciences Corporation
Investigators
Study Director: Guy Gammon, MB BS, MRCP Interim Chief Medical Officer / Ambit Biosciences Corporation
  More Information

No publications provided

Responsible Party: Ambit Biosciences Corporation
ClinicalTrials.gov Identifier: NCT01287858     History of Changes
Other Study ID Numbers: AC430-001
Study First Received: January 12, 2011
Last Updated: April 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014