HealthyPhase 1NCT02803762
Investigate Absorption, Metabolism, Excretion, and Mass Balance of Pacritinib
A Phase 1 study testing Pacritinib in people with Healthy, run by CTI BioPharma at 1 site in Netherlands.
Trial summary
This study is an open-label, absorption, metabolism, excretion, and mass balance study of 400 mg [14C]pacritinib (containing 100 μCi radioactivity) administered orally as a single dose to 6 healthy male subjects following at least a 10-hour fast (not including water) on Day 1. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pacritinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2014to Oct 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking men between 18 and 55 years of age (inclusive)
- ECG within normal limits (according to the criteria used by QPS Netherlands BV including QTc interval (less than or equal to 450 m/sec)
- Normal vital signs measurements [defined as blood pressure (BP) between 90-140 mmHg systolic and 50-90 mmHg diastolic, resting heart rate (HR) between 40-100 beats/min, temperature (T) less than or equal to 37.6 degree C])
- Body mass index of 19.0-29.0 kg/m2 inclusive
- Negative history of drug abuse or alcoholism within 1 year prior to Day 1
- Negative tests on drug and alcohol screen at Screening and Check-in
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- Negative hepatitis panel including hepatitis B-surface antigen HBsAg], hepatitis C antibody [anti-HCV] and negative human immunodeficiency virus antibody (HIV)
- No clinical laboratory value outside of the normal reference range unless deemed not clinically significant by the Investigator in consultation with the Sponsor
- Fertile male subjects and fertile female sexual partners of male subjects agree to use effective birth control methods throughout the entire study. Female partners of childbearing potential must use highly effective methods (defined as those resulting in a failure rate of <1% per year when used consistently and correctly). The contraceptive methods considered highly effective are intrauterine devices and hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices, or injections with prolonged release). Male subjects must use a condom with spermicide paste for the duration of the study and for 90 days after the EOS evaluation. When abstinence is used as a method of birth control, only true abstinence is acceptable, when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, ovulation, symptothermal, and post-ovulation methods) and withdrawal are not acceptable methods of contraception
- Agreement to not donate sperm throughout the entire study and for 3 months after the end of the study
- Willingness to comply with the protocol, including restrictions on diet, physical activity, and use of alcohol, medications, and other drugs during the study
- Comprehend and willingness to sign an approved informed consent form for the study
- At least one bowel movement a day
Who cannot join
- Participation in another radioactive clinical trial within the past 12 months
- Actively participating in an experimental therapy study or who have received experimental therapy within 90 days of Day 1
- Use of any other prescription medication within 21 days of Day 1, unless approved by Sponsor
- Use of over-the-counter (OTC) medications or nonprescription preparations (including vitamins, minerals and phytotherapeutic/herbal/plant-derived preparations) that is known to induce drug-metabolizing enzymes, including CYP450 enzymes within the 7 days preceding Day 1 (except for spermicidal/barrier contraceptive products and paracetamol)
- Consumption of alcoholic beverages within 72 hours prior to Check-in (Day -1)
- Consumption of grapefruit- and grapefruit-containing products within 7 days prior to Day 1
Show all 19Show fewer
- Consumption of xanthine containing beverages such as coffee, including energy drinks containing caffeine or tea within 2 days of Day 1
- Clinically significant abnormal physical finding at Screening
- Any severe acute or chronic medical condition, psychiatric condition, or laboratory abnormality that in the Investigator's opinion may increase the risk associated with study participation or administration of study treatment, or interfere with the interpretation of study results (such as gastrointestinal surgical history (except appendectomy), ileus or obstructive uropathy)
- Diarrhea, nausea or vomiting within 7 days of Day 1
- History of additional risk factors for torsade de pointes (TdP) (e.g. heart failure, hypokalemia defined as serum potassium <3.0 mmol/L, family history of Long QT Syndrome)
- Any illness during the 4 weeks prior to Day 1, unless deemed NCS by the Principal Investigator
- Any history of severe allergic reaction (including drugs, food, insect bites, environmental allergens)
- Known history or presence of food allergies or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
- Any surgical procedures within 72 hours of Day 1
- Blood draws of more than 400 mL during the conduct of any clinical study within 90 days prior to Day 1
- Poor peripheral venous access
- Donation of blood 30 days prior to Screening through end of study
- Employment in a position that exposes the subject to radiation or requires that the subject's degree of radiation exposure be monitored (e.g. radiology technician)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study to Investigate the Absorption, Metabolism, Excretion, and Mass Balance of [14C] Pacritinib Following a Single Oral Dose in Healthy Male Subjects
This study is an open-label, absorption, metabolism, excretion, and mass balance study of 400 mg [14C]pacritinib (containing 100 μCi radioactivity) administered orally as a single dose to 6 healthy male subjects following at least a 10-hour fast (not including water) on Day 1.
Read the detailed description
The present study is designed to investigate the absorption, metabolism, excretion as well as safety/tolerability of pacritinib following the administration of a single oral dose to healthy male volunteers. The pacritinib dose is administered with a [14C]-labeled form to enable detection and quantitation of dose-related material independent of possible biotransformation. The study design allows detection of potential human specific metabolites that have not been detected in the animal species. Subjects are confined at the clinical site from the time of Check-in until Day 14 post-dose, but may be discharged from the clinical site between Day 10 and 13 post-dose if study discharge criteria are met (i.e. completion of sufficient radioactivity excretion). All remaining subjects will be discharged from the clinical site on Day 14 post-dose irrespective of the study discharge criteria. The data obtained in this study will be used for the further clinical development of the compound.
- Conditions
- Healthy
- Being tested
- Pacritinib
- Keywords
- ADME, Pacritinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PacritinibDrug
400 mg [14C]pacritinib (containing 100 μCi radioactivity) administered orally as a single dose following at least a 10-hour fast (not including water) on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Investigational: [14C] Pacritinib | Experimental | All enrolled subjects are checked in the day before drug administration. Following at least a 10-hour fast (not including water), each subject will receive an oral dose of 400 mg [14C]pacritinib (containing 100 μCi radioactivity). Receives: Drug: Pacritinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum plasma concentration (Cmax)
The PK parameters for [14C] pacritinib will be derived by non-compartmental analysis of the plasma concentration-time profiles and the PK parameters for the metabolites will be calculated, as deemed appropriate, based on the results of quantitative profiling performed on selected plasma and pooled urine samples from individual subjects
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose every 24 hours thereafter until Day 10, no later than Day 14
The time to reach maximum plasma concentration (tmax)
The PK parameters for [14C] pacritinib will be derived by non-compartmental analysis of the plasma concentration-time profiles and the PK parameters for the metabolites will be calculated, as deemed appropriate, based on the results of quantitative profiling performed on selected plasma and pooled urine samples from individual subjects
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose every 24 hours thereafter until Day 10, no later than Day 14
The area under the plasma concentration-time curve from time zero to time of the last measured concentration above the limit of quantification (AUC0-t)
The PK parameters for [14C] pacritinib will be derived by non-compartmental analysis of the plasma concentration-time profiles and the PK parameters for the metabolites will be calculated, as deemed appropriate, based on the results of quantitative profiling performed on selected plasma and pooled urine samples from individual subjects
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose every 24 hours thereafter until Day 10, no later than Day 14
The area under the plasma concentration-time curve from time zero to 48 hours (AUC0- 48h)
The PK parameters for [14C] pacritinib will be derived by non-compartmental analysis of the plasma concentration-time profiles and the PK parameters for the metabolites will be calculated, as deemed appropriate, based on the results of quantitative profiling performed on selected plasma and pooled urine samples from individual subjects
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose every 24 hours thereafter until Day 10, no later than Day 14
The area under the plasma concentration-time curve from zero to infinity (AUC0-∞)
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose every 24 hours thereafter until Day 10, no later than Day 14
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose every 24 hours thereafter until Day 10, no later than Day 14
Secondary outcomes (1)
Treatment-emergent adverse events (AEs) and serious adverse events (SAEs), vital Signs, PE, clinical laboratory valuations, and ECGs
Evaluate Safety and tolerability of a single oral dose of 400 mg [14C]pacritinib in healthy subjects
Measured: Day 1 through Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJul 2014
- Primary completionOct 2014
- Study completionOct 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- CTI BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- QPS-Qualitix
- Responsible party
- Sponsor
- Investigators
- Khalid A Elaziz, MBBS, MD, Principal investigator, QPS Netherlands BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803762
- Sponsor's protocol ID
- PAC102
- Status last verified
- May 2016
- First submitted
- 3 May 2016
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Investigate the Absorption, Metabolism, Excretion, and Mass Balance of [14C] Pacritinib Following a Single Oral Dose in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02803762
- Acronym / sponsor ID
- PAC102
- Conditions
- Healthy
- Keywords
- ADME, Pacritinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- CTI BioPharmaIndustry (pharma, biotech, devices)
- Collaborators
- QPS-Qualitix
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 17 Jun 2016 (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 an open-label, absorption, metabolism, excretion, and mass balance study of 400 mg [14C]pacritinib (containing 100 μCi radioactivity) administered orally as a single dose to 6 healthy male subjects following at least a 10-hour fast (not including water) on Day 1.
Detailed description
The present study is designed to investigate the absorption, metabolism, excretion as well as safety/tolerability of pacritinib following the administration of a single oral dose to healthy male volunteers. The pacritinib dose is administered with a [14C]-labeled form to enable detection and quantitation of dose-related material independent of possible biotransformation. The study design allows detection of potential human specific metabolites that have not been detected in the animal species. Subjects are confined at the clinical site from the time of Check-in until Day 14 post-dose, but may be discharged from the clinical site between Day 10 and 13 post-dose if study discharge criteria are met (i.e. completion of sufficient radioactivity excretion). All remaining subjects will be discharged from the clinical site on Day 14 post-dose irrespective of the study discharge criteria. The data obtained in this study will be used for the further clinical development of the compound.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational: [14C] Pacritinib | Experimental | Drug: PacritinibAll enrolled subjects are checked in the day before drug administration. Following at least a 10-hour fast (not including water), each subject will receive an oral dose of 400 mg [14C]pacritinib (containing 100 μCi radioactivity). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Non-smoking men between 18 and 55 years of age (inclusive)
- ECG within normal limits (according to the criteria used by QPS Netherlands BV including QTc interval (less than or equal to 450 m/sec)
- Normal vital signs measurements [defined as blood pressure (BP) between 90-140 mmHg systolic and 50-90 mmHg diastolic, resting heart rate (HR) between 40-100 beats/min, temperature (T) less than or equal to 37.6 degree C])
- Body mass index of 19.0-29.0 kg/m2 inclusive
- Negative history of drug abuse or alcoholism within 1 year prior to Day 1
Key exclusion criteria (19 listed)
- Participation in another radioactive clinical trial within the past 12 months
- Actively participating in an experimental therapy study or who have received experimental therapy within 90 days of Day 1
- Use of any other prescription medication within 21 days of Day 1, unless approved by Sponsor
- Use of over-the-counter (OTC) medications or nonprescription preparations (including vitamins, minerals and phytotherapeutic/herbal/plant-derived preparations) that is known to induce drug-metabolizing enzymes, including CYP450 enzymes within the 7 days preceding Day 1 (except for spermicidal/barrier contraceptive products and paracetamol)
- Consumption of alcoholic beverages within 72 hours prior to Check-in (Day -1)
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 |
|---|---|---|
| Pacritinib400 mg [14C]pacritinib (containing 100 μCi radioactivity) administered orally as a single dose following at least a 10-hour fast (not including water) on Day 1 | Drug | Investigational: [14C] Pacritinib |
Primary outcome
The maximum plasma concentration (Cmax)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose every 24 hours thereafter until Day 10, no later than Day 14
The PK parameters for [14C] pacritinib will be derived by non-compartmental analysis of the plasma concentration-time profiles and the PK parameters for the metabolites will be calculated, as deemed appropriate, based on the results of quantitative profiling performed on selected plasma and pooled urine samples from individual subjects
The time to reach maximum plasma concentration (tmax)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose every 24 hours thereafter until Day 10, no later than Day 14
The PK parameters for [14C] pacritinib will be derived by non-compartmental analysis of the plasma concentration-time profiles and the PK parameters for the metabolites will be calculated, as deemed appropriate, based on the results of quantitative profiling performed on selected plasma and pooled urine samples from individual subjects
The area under the plasma concentration-time curve from time zero to time of the last measured concentration above the limit of quantification (AUC0-t)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose every 24 hours thereafter until Day 10, no later than Day 14
The PK parameters for [14C] pacritinib will be derived by non-compartmental analysis of the plasma concentration-time profiles and the PK parameters for the metabolites will be calculated, as deemed appropriate, based on the results of quantitative profiling performed on selected plasma and pooled urine samples from individual subjects
The area under the plasma concentration-time curve from time zero to 48 hours (AUC0- 48h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose every 24 hours thereafter until Day 10, no later than Day 14
The PK parameters for [14C] pacritinib will be derived by non-compartmental analysis of the plasma concentration-time profiles and the PK parameters for the metabolites will be calculated, as deemed appropriate, based on the results of quantitative profiling performed on selected plasma and pooled urine samples from individual subjects
The area under the plasma concentration-time curve from zero to infinity (AUC0-∞)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose every 24 hours thereafter until Day 10, no later than Day 14
0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose every 24 hours thereafter until Day 10, no later than Day 14
1 secondary outcome
Treatment-emergent adverse events (AEs) and serious adverse events (SAEs), vital Signs, PE, clinical laboratory valuations, and ECGs
Time frame: Day 1 through Day 42
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 17 Jun 2016.
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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.
Khalid A Elaziz, MBBS, MD principal investigator
QPS Netherlands BV
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 Pacritinib in people with Healthy, run by CTI BioPharma at 1 site in Netherlands.
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 13 inclusion and 19 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 17 Jun 2016. 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 Netherlands. 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?
The maximum plasma concentration (Cmax) (time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose every 24 hours thereafter until Day 10, no later than Day 14). The study lists 5 primary outcomes in all. 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 17 Jun 2016.