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.
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:
- Healthy normal males and females, age 18 to 45, inclusive, at the time of consent
- Able to communicate effectively in the English language
- Able to provide valid, written informed consent
- Able to swallow up to 20 capsules of study drug
- BMI (body mass index) ranging between 18 and 30 kg/m2, inclusive
- Minimum weight of 50 kg
- Serum Creatinine ≤ ULN (upper limit of normal) and estimated creatinine clearance at screening of ≥ 80 mL/min per the Cockcroft-Gault equation
- Total serum bilirubin ≤ ULN (may be repeated to confirm eligibility)
- Serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ ULN (may be repeated to confirm eligibility)
- 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.
- Female participants must be either of non-child-bearing potential or agree to use an acceptable form of birth control.
Important Exclusion Criteria:
- History of clinically significant drug allergy
- Participation in another clinical trial with receipt of an Investigational Product within 90 days before dose administration (or 5 half-lives, whichever is longer)
- Major surgery within 90 days before study enrollment
- Use of prescription, over the counter, or herbal medications or supplements, including oral contraceptives within 14 days of check-in
- A history of drug abuse or a history of alcohol abuse within 1 year prior to Screening
- Current or recent (within 30 days before enrollment) use of tobacco or nicotine products
- 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
- Inadequate venous access that would interfere with obtaining blood samples
- Recipients of blood transfusion or transfusion of blood or plasma products, within 90 days before study drug administration
- Donation of blood ≥ 500 mL within 2 months before study drug administration
- 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
- 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)
- Abnormal laboratory values that are considered clinically significant by the Investigator
- History of cancer
- History of eating disorders within the past 3 months
- History of a seizure disorder or clinically significant head injury
- Positive urine drug screen for drugs of abuse including alcohol
- Active infection within 90 days of check-in
- 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
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.
- Conditions
- Rheumatoid Arthritis
- 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 group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: AC430 |
| AC430 | Active comparator | AC430 Receives: Drug: AC430 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted2 Feb 2011 (estimated)
- Study startNov 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guy Gammon, MB BS, MRCP, Study director, Interim Chief Medical Officer / Ambit Biosciences Corporation
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01287858
- Acronym / sponsor ID
- AC430-001
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: AC430Placebo |
| AC430 | Active comparator | Drug: AC430AC430 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AC430Healthy volunteers will either receive AC430 or placebo. | Drug | AC430, Placebo |
Primary outcome
Assess the safety, tolerability, and pharmacokinetics of single and multiple oral doses of AC430.
Time frame: 6 months
* 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]
1 secondary outcome
Determine the pharmacodynamic effects of single and multiple oral doses of AC430.
Time frame: Measured at specific timepoints prior to and following dosing regimen.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Gammon, MB BS, MRCP study director
Interim Chief Medical Officer / Ambit Biosciences Corporation
1 site in 1 country: see every site and its status.
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.