HealthyPhase 1NCT02088398
Alternative 10 mg/mL Liquid Formulation of ACY 1215 (Ricolinostat) in Healthy Subjects
A Phase 1 study testing ACY-1215 in people with Healthy, run by Acetylon Pharmaceuticals Incorporated at 1 site in United States.
Trial summary
This study will be an open-label, randomized, single dose, 3-period crossover PK study. This study will comprise 3 treatment periods with a 4-day washout between periods. On Day -1, subjects will be randomized to 1 of 6 treatment sequences. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ACY-1215
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Apr 2014
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 65 years of age, inclusive
- BMI range 18.5 to 32.0 kg/m2
- in good health, as determined by no clinically significant findings from medical history, 12-lead ECG, vital signs
- clinical laboratory evaluations, CBC, coagulation, and UA
- negative test for selected drugs of abuse
- negative hepatitis panel and negative HIV antibody
- females of non-childbearing potential as outlined in protocol
- males either be sterile or agree to use contraception as outlined in protocol
Who cannot join
- significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
- history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- history of Gilbert's Syndrome or suspicion of Gilbert's Syndrome
- abnormality in the 12-lead ECG (e.g. QTcF of >450 msec, a history of a prolonged QTc-interval or Brugada syndrome)
- history of alcoholism or drug addiction within 1 year prior
Show all 13Show fewer
- participation in any other investigational study drug trial in which receipt of an investigational study drug as outlined in protocol
- use of any prescription medications/products within 14 days (30 days for cytochrome P450 [CYP]-inducing or inhibiting products as outlined in protocol)
- use of any over-the-counter, nonprescription preparations within 14 days
- use of any tobacco or nicotine-containing products within 6 months and during study;
- poor peripheral venous access
- donation of blood from 30 days prior to Screening through the Follow-up visit
- any acute or chronic condition that, in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in this clinical study
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit Incorporated
Madison, Wisconsin, 53704
About this study
Official title: Open-Label, Randomized, Single Dose, 3-Period Crossover to Evaluate the Relative Bioavailability and Food-Effect on Pharmacokinetics of Alternative 10 mg/mL Liquid Formulation ACY-1215 (Ricolinostat) in Healthy Subjects
This study will be an open-label, randomized, single dose, 3-period crossover PK study. This study will comprise 3 treatment periods with a 4-day washout between periods. On Day -1, subjects will be randomized to 1 of 6 treatment sequences. On Days 1, 5, and 9, subjects will be administered Treatment A, B, or C according to the randomization schedule.
- Treatment A: a single dose of 160 mg ACY-1215 CLF (20 mg/mL) in the fed state
- Treatment B: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) in the fed state
- Treatment C: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) in the fasted state
Read the detailed description
Subjects will be confined to the Clinical Research Unit (CRU) from the time of Check-in (Day -1) to Day 10. Predose blood and urine samples will be obtained prior to each ACY-1215 administration. Following administration of ACY-1215 in each period, blood and urine samples will be collected at specified timepoints or intervals through 24 hours postdose for the determination of the PK of a single oral dose of ACY-1215. Subjects will be discharged from the CRU on Day 10, following the completion of the last PK collection and successful completion and evaluation of discharge safety tests. Subjects will return to the clinic for a Follow-up visit 5 to 7 days after the last dose of ACY-1215 (Days 14 to 16) for additional safety evaluations.
- Conditions
- Healthy
- Being tested
- ACY-1215
- Keywords
- relative bioavailability, food-effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACY-1215Drug
| Study group | Role | What they receive |
|---|---|---|
| 160 mg ACY-1215 CLF (20 mg/mL) fed | Experimental | • Treatment A: a single dose of 160 mg ACY-1215 CLF (20 mg/mL) in the fed state Receives: Drug: ACY-1215 |
| 120 mg ACY-1215 ALF (10 mg/mL) fed | Experimental | • Treatment B: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) in the fed state Receives: Drug: ACY-1215 |
| 120 mg ACY-1215 ALF (10 mg/mL) fasted | Experimental | • Treatment C: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) Receives: Drug: ACY-1215 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve From Zero to Last Time - AUC0-last
Measured: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hr post first dose
Secondary outcomes (4)
Safety and tolerability parameters
Changes from baseline in clinical laboratory assessments, vital signs, electrocardiogram values, and physical exam. This includes collection of adverse events and the collection of concomitant medications.
Measured: Day 1 (first dose of ACY-1215) to Day 16
Area Under the Curve From Time Zero to Extrapolated Infinite Time
Measured: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hr post first dose
Maximum Observed Plasma Concentration (Cmax)
Measured: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hr post first dose
Plasma Decay Half-Life
Measured: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hr post first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acetylon Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas Siebers, M.D., Principal investigator, Covance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088398
- Sponsor's protocol ID
- ACE-HV-100
- Status last verified
- Sep 2014
- First submitted
- 5 Mar 2014
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Randomized, Single Dose, 3-Period Crossover to Evaluate the Relative Bioavailability and Food-Effect on Pharmacokinetics of Alternative 10 mg/mL Liquid Formulation ACY-1215 (Ricolinostat) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02088398
- Acronym / sponsor ID
- ACE-HV-100
- Conditions
- Healthy
- Keywords
- relative bioavailability, food-effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Acetylon Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 17 Mar 2014 (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.
This study will be an open-label, randomized, single dose, 3-period crossover PK study. This study will comprise 3 treatment periods with a 4-day washout between periods. On Day -1, subjects will be randomized to 1 of 6 treatment sequences. On Days 1, 5, and 9, subjects will be administered Treatment A, B, or C according to the randomization schedule.
- Treatment A: a single dose of 160 mg ACY-1215 CLF (20 mg/mL) in the fed state
- Treatment B: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) in the fed state
- Treatment C: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) in the fasted state
Detailed description
Subjects will be confined to the Clinical Research Unit (CRU) from the time of Check-in (Day -1) to Day 10. Predose blood and urine samples will be obtained prior to each ACY-1215 administration. Following administration of ACY-1215 in each period, blood and urine samples will be collected at specified timepoints or intervals through 24 hours postdose for the determination of the PK of a single oral dose of ACY-1215. Subjects will be discharged from the CRU on Day 10, following the completion of the last PK collection and successful completion and evaluation of discharge safety tests. Subjects will return to the clinic for a Follow-up visit 5 to 7 days after the last dose of ACY-1215 (Days 14 to 16) for additional safety evaluations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 160 mg ACY-1215 CLF (20 mg/mL) fed | Experimental | Drug: ACY-1215• Treatment A: a single dose of 160 mg ACY-1215 CLF (20 mg/mL) in the fed state |
| 120 mg ACY-1215 ALF (10 mg/mL) fed | Experimental | Drug: ACY-1215• Treatment B: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) in the fed state |
| 120 mg ACY-1215 ALF (10 mg/mL) fasted | Experimental | Drug: ACY-1215• Treatment C: a single dose of 120 mg ACY-1215 ALF (10 mg/mL) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 to 65 years of age, inclusive
- BMI range 18.5 to 32.0 kg/m2
- in good health, as determined by no clinically significant findings from medical history, 12-lead ECG, vital signs
- clinical laboratory evaluations, CBC, coagulation, and UA
- negative test for selected drugs of abuse
Key exclusion criteria (13 listed)
- significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
- history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- history of Gilbert's Syndrome or suspicion of Gilbert's Syndrome
- abnormality in the 12-lead ECG (e.g. QTcF of >450 msec, a history of a prolonged QTc-interval or Brugada syndrome)
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 |
|---|---|---|
| ACY-1215 | Drug | 120 mg ACY-1215 ALF (10 mg/mL) fasted, 120 mg ACY-1215 ALF (10 mg/mL) fed, 160 mg ACY-1215 CLF (20 mg/mL) fed |
Primary outcome
Area Under the Curve From Zero to Last Time - AUC0-last
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hr post first dose
4 secondary outcomes
Safety and tolerability parameters
Time frame: Day 1 (first dose of ACY-1215) to Day 16
Area Under the Curve From Time Zero to Extrapolated Infinite Time
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hr post first dose
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hr post first dose
Plasma Decay Half-Life
Time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hr post first dose
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 11 Sep 2014.
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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.
Nicholas Siebers, M.D. principal investigator
Covance
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 ACY-1215 in people with Healthy, run by Acetylon Pharmaceuticals Incorporated 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?
The sponsor lists 8 inclusion and 13 exclusion criteria. 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 11 Sep 2014. 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. 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?
Area Under the Curve From Zero to Last Time - AUC0-last (time frame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hr post first dose). 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 11 Sep 2014.