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

NCT ID: NCT01287858

Last Updated: 2015-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-06-30

Brief Summary

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.

Detailed Description

A dose-finding study of AC430 in healthy volunteers.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

AC430

Intervention Type: DRUG

Healthy volunteers will either receive AC430 or placebo.

AC430

AC430

Group Type: ACTIVE_COMPARATOR

AC430

Intervention Type: DRUG

Healthy volunteers will either receive AC430 or placebo.

Interventions

AC430

Healthy volunteers will either receive AC430 or placebo.

Intervention Type: DRUG

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guy Gammon, MB BS, MRCP

Role: STUDY_DIRECTOR

Interim Chief Medical Officer / Ambit Biosciences Corporation

Locations

Covance Clinical Research Unit

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

AC430-001

Identifier Type: -

Identifier Source: org_study_id