Healthy VolunteersEarly Phase 1HVFENCT02058784
Study to Evaluate the Food Effect of Single-dose Bioavailability of Pracinostat in Healthy Adult Subjects
A Early Phase 1 study testing pracinostat in people with Healthy Volunteers and Moderate to Heavy Smokers, run by Helsinn Healthcare SA at 1 site in United States.
Trial summary
Open label study of Pracinostat will be tested to assess the effect of food on the single-dose pharmacokinetics in healthy non-smoking and smoking adult subjects under fasted and fed conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Moderate to Heavy Smokers, Non-smokers
- What is being tested?
- pracinostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Mar 2014
- Phase
- Early 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, adult, male or female, 18-55 years of age, inclusive, at screening.
- Cohort 1 only: continuous nonsmoker who has not used nicotine-containing products for at least 6 months prior to the first dose and confirmed by urine cotinine test at screening.
- Cohort 2 only: moderate to heavy smokers defined as > 1 pack of cigarettes per day or > 39 cigarettes per week for at least 6 months prior to the first dose and confirmed by urine cotinine test at screening.
- Body Mass Index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI.
- For a female of non-childbearing potential:
- A non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study medication. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to study start. A male who has been vasectomized less than 4 months prior to study start must follow the same restrictions as a non vasectomized male).
- Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol
Who cannot join
- Subject is mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
- History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years prior to screening.
- History or presence of hypersensitivity or idiosyncratic reaction to the study medication or related compounds.
- History of prolonged QT syndrome.
Show all 21Show fewer
- Positive urine drug and alcohol results at screening or check-in.
- Positive results at screening for HIV, HBsAg or HCV.
- Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.
- Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening.
- QTcF interval, is >430 msec (males) or >450 msec (females) or deemed clinically abnormal by the PI at screening or Period 1 check-in
- Unable to refrain from or anticipates the use of:
- Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning approximately 14 days prior to the first dose of study medication and throughout the study.
- Any drugs known to be significant inducers of CYP enzymes, including St. John's Wort, for 28 days prior to the first dose dosing of study medication and throughout the study. Appropriate sources will be consulted by the PI or designee to confirm lack of PK/pharmacodynamics interaction with study medication.
- Have been on a diet incompatible with the on-study diet, in the opinion of the PI, within the 28 days prior to the first dose of study medication(s), and throughout the study.
- Hemoglobin, platelet count or absolute neutrophils below the lower limit of normal at screening.
- Potassium or magnesium below the lower limit of normal at screening.
- Aspartate aminotransferase and alanine aminotransferase above upper limit of normal at screening.
- Donation of blood or significant blood loss within 56 days prior to the first dose of study medication.
- Plasma donation within 7 days prior to the first dose of study medication.
- Participation in another clinical trial within 28 days prior to the first dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 2-Cohort Study to Evaluate the Effect of Food and the Effect of Cigarette Smoking on the Single-Dose Bioavailability of Pracinostat in Healthy Adult Subjects
Open label study of Pracinostat will be tested to assess the effect of food on the single-dose pharmacokinetics in healthy non-smoking and smoking adult subjects under fasted and fed conditions.
- Conditions
- Healthy Volunteers, Moderate to Heavy Smokers, Non-smokers
- Being tested
- pracinostat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pracinostatDrug
| Study group | Role | What they receive |
|---|---|---|
| Single-dose food effect in nonsmokers | Experimental | Randomized, two-treatment design in nonsmoking healthy subjects. Single-dose pracinostat to be given under fasted and fed conditions followed by PK sampling for up to 48 hour post dose. Receives: Drug: pracinostat |
| Single-dose food effect in smokers | Experimental | Single-dose parallel treatment design in moderate to heavy smoking healthy subjects. Single-dose pracinostat will be given under fasted conditions followed by PK blood sampling up to 48 hours. Receives: Drug: pracinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the effect of food on a single-dose PK of pracinostat in nonsmoking healthy adult subjects
Assess the ratios of least square means of pracinostat plasma PK parameters AUC 0-t, AUC 0-inf and Cmax for pracinostat under fed versus fasted conditions
Measured: 3 days
Secondary outcomes (1)
Evaluate the safety and tolerability of a single-dose of pracinostat under fasted and fed conditions in healthy nonsmoking and smoking adult subjects
All types of adverse events, physical exams, vital signs, 12-lead ECGs, and laboratory safety tests will be performed
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinn Healthcare SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Terry E O'Reilly, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058784
- Sponsor's protocol ID
- MEI-006
- Acronym
- HVFE
- Status last verified
- Feb 2017
- First submitted
- 6 Feb 2014
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Cohort Study to Evaluate the Effect of Food and the Effect of Cigarette Smoking on the Single-Dose Bioavailability of Pracinostat in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02058784
- Acronym / sponsor ID
- HVFE / MEI-006
- Conditions
- Healthy Volunteers, Moderate to Heavy Smokers, Non-smokers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Helsinn Healthcare SAIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- Feb 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 10 Feb 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.
Open label study of Pracinostat will be tested to assess the effect of food on the single-dose pharmacokinetics in healthy non-smoking and smoking adult subjects under fasted and fed conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-dose food effect in nonsmokers | Experimental | Drug: pracinostatRandomized, two-treatment design in nonsmoking healthy subjects. Single-dose pracinostat to be given under fasted and fed conditions followed by PK sampling for up to 48 hour post dose. |
| Single-dose food effect in smokers | Experimental | Drug: pracinostatSingle-dose parallel treatment design in moderate to heavy smoking healthy subjects. Single-dose pracinostat will be given under fasted conditions followed by PK blood sampling up to 48 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy, adult, male or female, 18-55 years of age, inclusive, at screening.
- Cohort 1 only: continuous nonsmoker who has not used nicotine-containing products for at least 6 months prior to the first dose and confirmed by urine cotinine test at screening.
- Cohort 2 only: moderate to heavy smokers defined as > 1 pack of cigarettes per day or > 39 cigarettes per week for at least 6 months prior to the first dose and confirmed by urine cotinine test at screening.
- Body Mass Index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI.
Key exclusion criteria (21 listed)
- Subject is mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
- History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History or presence of alcoholism or drug abuse within the past 2 years prior to screening.
- History or presence of hypersensitivity or idiosyncratic reaction to the study medication or related compounds.
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 |
|---|---|---|
| pracinostat | Drug | Single-dose food effect in nonsmokers, Single-dose food effect in smokers |
Primary outcome
Assess the effect of food on a single-dose PK of pracinostat in nonsmoking healthy adult subjects
Time frame: 3 days
Assess the ratios of least square means of pracinostat plasma PK parameters AUC 0-t, AUC 0-inf and Cmax for pracinostat under fed versus fasted conditions
1 secondary outcome
Evaluate the safety and tolerability of a single-dose of pracinostat under fasted and fed conditions in healthy nonsmoking and smoking adult subjects
Time frame: 1 month
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 23 Feb 2017.
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
RecruitingEarly Phase 1
Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers
Irritability
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.
Terry E O'Reilly, MD principal investigator
Celerion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing pracinostat in people with Healthy Volunteers and Moderate to Heavy Smokers, run by Helsinn Healthcare SA 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 21 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 23 Feb 2017. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 effect of food on a single-dose PK of pracinostat in nonsmoking healthy adult subjects (time frame: 3 days). 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 23 Feb 2017.