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Rheumatoid ArthritisPhase 1NCT01287858

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

A Phase 1 study testing AC430 in people with Rheumatoid Arthritis, run by Daiichi Sankyo at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
AC430
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
1 siteUnited States
Study dates
Nov 2010to Jun 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Covance Clinical Research Unit

    Madison, Wisconsin, 53718

Other trials in United States

About this study

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

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.

Read the detailed description

A dose-finding study of AC430 in healthy volunteers.

Being tested
AC430
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AC430Drug

    Healthy volunteers will either receive AC430 or placebo.

Study groups in NCT01287858
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo
Receives: Drug: AC430
AC430Active comparatorAC430
Receives: Drug: AC430

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess the safety, tolerability, and pharmacokinetics of single and multiple oral doses of AC430.

    • 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]

    Measured: 6 months

Secondary outcomes (1)
  1. Determine the pharmacodynamic effects of single and multiple oral doses of AC430.

    • 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]

    Measured: Measured at specific timepoints prior to and following dosing regimen.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2011 (estimated)
  2. Study startNov 2010
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01287858
Sponsor's protocol ID
AC430-001
Status last verified
Oct 2015
First submitted
12 Jan 2011
Last updated
2 Nov 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AC430 in people with Rheumatoid Arthritis, run by Daiichi Sankyo at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess the safety, tolerability, and pharmacokinetics of single and multiple oral doses of AC430. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2015.

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