Healthy VolunteersPhase 1NCT02118909
Evaluate the Effects of Itraconazole and Ciprofloxacin on Single-Dose PK of Pracinostat in Healthy Nonsmoking Subjects
A Phase 1 study testing Pracinostat, Itraconazole and Ciprofloxacin in people with Healthy Volunteers and Non-smokers, run by Helsinn Healthcare SA at 1 site in United States.
Trial summary
This study is designed as a 2-part, open-label study to assess the effect of pracinostat with itraconazole (part 1) and pracinostat with ciprofloxacin (part 2) on the bioavailability of pracinostat. Secondarily to evaluate the safety and tolerability of pracinostat administered with itraconazole or ciprofloxacin. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Non-smokers
- What is being tested?
- Pracinostat, Itraconazole and Ciprofloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Aug 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer
- Continuous nonsmoker who has not used nicotine-containing products for at least 3 months prior to the first dose
- 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.
- Female subjects must be of non-childbearing potential and must have undergone sterilization procedures at least 6 months prior to the first dose or be postmenopausal with amenorrhea for at least 1 year prior to the first dose and follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status.
- 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.
- 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 or require any current medications which may prolong QTc.
Show all 23Show fewer
- History or presence of:
- myasthenia gravis;
- convulsions.
- Female subjects who are pregnant or lactating.
- Positive urine cotinine, 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 mgHg 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 clinical abnormal by the PI at screening or prior to dosing.
- Unable to refrain from or anticipates the use of:
- Any drug, including prescription and non-prescription medications, tobacco, antacids, herbal remedies, or vitamin supplements beginning approximately 14 days prior to the first dose of study medication and throughout the study. Hormone replacement therapy will be allowed if postmenopausal females are on a stable treatment for at least 1 month prior to dosing on Day 1 of Period 1. Acetaminophen (up to 2 g per 24 hour period) may be permitted during 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 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.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 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.
- 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 Two-Part Study to Evaluate the Effect of CYP3A4 Inhibition (Itraconazole-Part 1) and CYP1A2 Inhibition (Ciprofloxacin - Part 2) on the Single-Dose Pharmacokinetics of Pracinostat in Healthy Nonsmoking Subjects
This study is designed as a 2-part, open-label study to assess the effect of pracinostat with itraconazole (part 1) and pracinostat with ciprofloxacin (part 2) on the bioavailability of pracinostat. Secondarily to evaluate the safety and tolerability of pracinostat administered with itraconazole or ciprofloxacin.
- Conditions
- Healthy Volunteers, Non-smokers
- Being tested
- Pracinostat, Itraconazole, Ciprofloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PracinostatDrug
ItraconazoleDrug
CiprofloxacinDrug
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (Pracinostat + Itraconazole) | Experimental | Single-dose pracinostat and itraconazole dosing every day for 8 days Receives: Drug: Pracinostat; Drug: Ciprofloxacin |
| Part 2 (Pracinostat + Ciprofloxacin) | Experimental | Single dose pracinostat and ciprofloxacin 2 times a day for 7 days Receives: Drug: Pracinostat; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration Cmax in healthy nonsmoking subjects given a single-dose of pracinostat
Plasma PK parameter Cmax to describe bioavailability of pracinostat
Measured: pre-dose, 0.25, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours
Secondary outcomes (2)
Number of participants with Adverse Events as a measure of safety and tolerability of single-dose pracinostat when administered with itraconazole or with ciprofloxacin in healthy nonsmoking adult subjects.
Safety will be monitored through physical examinations, vital sign measurements, electrocardiograms, adverse events, and clinical laboratory tests.
Measured: 1 month
Peak plasma PK concentration Area Under the Curve (AUC)AUC 0-t, AUC 0-inf in healthy nonsmoking subjects given a single dose of pracinostat
Plasma PK parameter AUC 0-t, AUC 0-inf for pracinostat
Measured: pre-dose, 0.25, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2014
- Study completionAug 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
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinn Healthcare SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Terry E O'Reilly, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118909
- Sponsor's protocol ID
- MEI-007
- Status last verified
- Feb 2017
- First submitted
- 11 Apr 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 Two-Part Study to Evaluate the Effect of CYP3A4 Inhibition (Itraconazole-Part 1) and CYP1A2 Inhibition (Ciprofloxacin - Part 2) on the Single-Dose Pharmacokinetics of Pracinostat in Healthy Nonsmoking Subjects
- ClinicalTrials.gov ID
- NCT02118909
- Acronym / sponsor ID
- MEI-007
- Conditions
- Healthy Volunteers, Non-smokers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Helsinn Healthcare SAIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 21 Apr 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 is designed as a 2-part, open-label study to assess the effect of pracinostat with itraconazole (part 1) and pracinostat with ciprofloxacin (part 2) on the bioavailability of pracinostat. Secondarily to evaluate the safety and tolerability of pracinostat administered with itraconazole or ciprofloxacin.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 (Pracinostat + Itraconazole) | Experimental | Drug: Pracinostat, Drug: CiprofloxacinSingle-dose pracinostat and itraconazole dosing every day for 8 days |
| Part 2 (Pracinostat + Ciprofloxacin) | Experimental | Drug: Pracinostat, Drug: ItraconazoleSingle dose pracinostat and ciprofloxacin 2 times a day for 7 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy volunteer
- Continuous nonsmoker who has not used nicotine-containing products for at least 3 months prior to the first dose
- 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.
- Female subjects must be of non-childbearing potential and must have undergone sterilization procedures at least 6 months prior to the first dose or be postmenopausal with amenorrhea for at least 1 year prior to the first dose and follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status.
Key exclusion criteria (23 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 | Part 1 (Pracinostat + Itraconazole), Part 2 (Pracinostat + Ciprofloxacin) |
| Itraconazole | Drug | Part 2 (Pracinostat + Ciprofloxacin) |
| Ciprofloxacin | Drug | Part 1 (Pracinostat + Itraconazole) |
Primary outcome
Peak plasma concentration Cmax in healthy nonsmoking subjects given a single-dose of pracinostat
Time frame: pre-dose, 0.25, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours
Plasma PK parameter Cmax to describe bioavailability of pracinostat
2 secondary outcomes
Number of participants with Adverse Events as a measure of safety and tolerability of single-dose pracinostat when administered with itraconazole or with ciprofloxacin in healthy nonsmoking adult subjects.
Time frame: 1 month
Peak plasma PK concentration Area Under the Curve (AUC)AUC 0-t, AUC 0-inf in healthy nonsmoking subjects given a single dose of pracinostat
Time frame: pre-dose, 0.25, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours
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.
- Sponsor websiteLink provided by the sponsor.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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 Phase 1 study testing Pracinostat, Itraconazole and Ciprofloxacin in people with Healthy Volunteers and Non-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 7 inclusion and 23 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?
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?
Peak plasma concentration Cmax in healthy nonsmoking subjects given a single-dose of pracinostat (time frame: pre-dose, 0.25, 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours). 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.