HealthyPhase 1NCT04981704
A Study to Evaluate the Effect of Multiple Doses of Itraconazole, Phenytoin, and Paroxetine on the Single-Dose Pharmacokinetics of Poziotinib in Healthy Adult Participants
A Phase 1 study testing Poziotinib, Itraconazole and Phenytoin in people with Healthy, run by Spectrum Pharmaceuticals, Inc at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the effect of multiple-doses of itraconazole, phenytoin and paroxetine on the single-dose pharmacokinetics (PK) of poziotinib in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Poziotinib, Itraconazole and Phenytoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2021to 17 Aug 2021
- 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, adult, male or female (of non-childbearing potential only), 18-55 years of age.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilogram per meter square (kg/m^2) at screening, and a minimum weight of 50.0 kg and a maximum weight of 100.0 kg at screening.
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study.
- Medically healthy with no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs, and laboratory evaluations.
- Female must be of non-childbearing potential only and must have undergone a sterilization procedure at least 6 months prior to the first dosing, or
- Postmenopausal women should have amenorrhea for at least 1 year prior to the first dosing.
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- A non-vasectomized male participant must agree to use a highly effective method of birth control with female partners of childbearing potential or with pregnant partners during the study and for 120 days following last dosing.
- Able to comprehend and willing to sign an Informed Consent Form (ICF) and abide by the clinical protocol, study procedures, and restrictions.
- For Part 1 only: Participant must be a CYP2D6 extensive metabolizer or CYP2D6 poor metabolizer as determined by a valid genotyping method.
- For Part 2 only: Participant must not be a CYP2C9 and CYP2C19 poor metabolizer as determined by a valid genotyping method and must be a CYP2D6 extensive metabolizer as determined by a valid genotyping method.
- For Part 3 only: Participant must be a CYP2D6 extensive metabolizer as determined by a valid genotyping method.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the PI (or designee).
- History of a developing or established acute event or infection in the prior 2 weeks to screening.
- History of significant hypersensitivity, or idiosyncratic reaction to poziotinib, itraconazole, phenytoin, paroxetine, or related drugs, food, or other substances.
- Any surgical or medical condition within 6 months prior to first dosing that may potentially alter absorption, distribution, metabolism or excretion of the study drugs, in the opinion of the PI (or designee).
- History or presence of alcoholism or drug/chemical abuse within 2 years prior to check-in.
- Female participants with a positive pregnancy test result or lactating.
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- Positive urine drug or alcohol test results at screening or check-in.
- Positive hepatitis panel (hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) and/or positive human immunodeficiency virus (HIV) test at screening. Automatic reflex Differential and ribonucleic acid testing will be conducted in the event of a reactive antibody/antigen screen.
- Seated blood pressure is less than 90/40 millimetre of mercury (mmHg) or greater than 140/90 mmHg at screening.
- Seated heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at screening.
- QT interval with Fridericia's correction (QTcF) interval is >450 millisecond (msec) (males) or >470 msec (females).
- Unable to refrain from or anticipates the use of:
- Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing and throughout the study. Hormone replacement therapy will not be allowed.
- Any drugs known to be inhibitors and/or inducers of CYP3A, CYP2D6, CYP2C9, or CYP2C19 enzymes; and/or P-gp; and/or gastric acid reducing agents (proton-pump inhibitors, H2-receptor antagonists, antacids) for 28 days prior to the first dosing and throughout the study (except those required as part of the study).
- Has a coagulation test (i.e., prothrombin time and activated partial thromboplastin time) outside of normal ranges at screening or at check-in.
- Has platelet, hemoglobin, or hematocrit that are below the lower limit of normal at screening or at check-in.
- Has alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin that are greater than the upper limit of normal at screening or at check-in.
- Estimated creatinine clearance <90 milliliter per minute (mL/min) at screening.
- Participation in another clinical study within 30 days prior to the first dosing.
- Prior exposure to poziotinib.
- For Part 1 Only:History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and as confirmed by the Sponsor:
- Ventricular dysfunction or risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, family history of Long QT Syndrome).
- Uncorrected hypokalemia (potassium levels < 3.7) and/or hypomagnesemia (magnesium levels < 1.9).
- Myasthenia gravis.
- For Part 2 Only: History of seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions which the Investigator considers to be clinically significant.
- Is at suicidal risk in the opinion of the PI as per the following criteria:
- Any suicidal attempts within 12 months prior to screening.
- any suicidal intent including a plan or C-SSRS answer of "YES" on suicidal ideation currently or within 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Celerion, Phoenix clinical facility
Tempe, Arizona, 85283
About this study
Official title: A Three-Part, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Multiple Doses of Itraconazole, Phenytoin, and Paroxetine on the Single-Dose Pharmacokinetics of Poziotinib in Healthy Adult Subjects
The purpose of the study is to evaluate the effect of multiple-doses of itraconazole, phenytoin and paroxetine on the single-dose pharmacokinetics (PK) of poziotinib in healthy adult participants.
Read the detailed description
This is a three-part study. Participants will be enrolled in Part 1 (Effects of Itraconazole), Part 2 (Effects of Phenytoin), or Part 3 (Effects of Paroxetine) on the Pharmacokinetics of Poziotinib. Each part will be an open-label, fixed-sequence, 2-period study and may be conducted concurrently. For each study part, participants will be housed on Day -1 of Treatment Period 1 in the Clinical Research Unit (CRU) and will remain confined in the CRU until after the last scheduled blood draw and/or study procedures in Treatment Period 2. In each part, there will be a washout period of at least 8 days between poziotinib doses.
A total of 75 (25 in each part) healthy, adult male and female participants will be enrolled targeting a female/male ratio greater than or equal to (≥) 1:3 in each study part.
In part 1, CYP2D6 extensive metabolizers will be primarily enrolled with a goal of enrolling at least 2 CYP2D6 poor metabolizers. In Parts 2 and 3, only CYP2D6 extensive metabolizers will be enrolled. In Part 2, CYP2C9 and CYP2C19 poor metabolizers will be excluded.
- Conditions
- Healthy
- Being tested
- Poziotinib, Itraconazole, Phenytoin, Paroxetine
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PoziotinibDrug
Poziotinib Tablets
ItraconazoleDrug
Itraconazole Oral solution
PhenytoinDrug
Phenytoin Capsules
ParoxetineDrug
Also called Paxil ®
Paroxetine Tablets
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Itraconazole/Poziotinib Drug-drug interaction (DDI) | Experimental | On Day 1 of Treatment period 1, a single oral dose of 8 milligrams (mg) poziotinib will be administered. On Day 1 of Treatment Period 2, 200 mg itraconazole oral solution will be administered twice a day (BID) followed by 200 mg itraconazole oral solution once daily (QD) for 7 consecutive days (Day 2 to Day 8) with a single oral dose of 8 mg poziotinib coadministered on Day 4. Receives: Drug: Poziotinib; Drug: Itraconazole |
| Part 2: Phenytoin/Poziotinib DDI | Experimental | On Day 1 of Treatment period 1, a single oral dose of 16 mg poziotinib will be administered. In treatment period 2, an oral dose of 100 mg phenytoin will be administered three times daily (TID) for 17 consecutive days (Day 1 to Day 17) with a single oral dose of 16 mg poziotinib coadministered on Day 14. Receives: Drug: Poziotinib; Drug: Phenytoin |
| Part 3: Paroxetine/Poziotinib DDI | Experimental | On Day 1 of Treatment Period 1, a single oral dose of 8 mg poziotinib will be administered. On Day 1 and Day 2 of Treatment Period 2, an oral dose of 20 mg paroxetine will be administered BID followed by 20 mg paroxetine QD for 9 consecutive days (Day 3 to Day 11) with a single oral dose of 8 mg poziotinib coadministered on Day 7. Receives: Drug: Poziotinib; Drug: Paroxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) of Poziotinib and Metabolites (M1 and M2) Following Poziotinib Administrations With and Without Itraconazole [Part 1], Phenytoin [Part 2], or Paroxetine [Part 3]
Measured: Part 1 and Part 3, predose and up to 120 hours postdose; Part 2, predose and up to 96 hours postdose
Maximum Observed Concentration (Cmax) of Poziotinib and Metabolites (M1 and M2) Following Poziotinib Administration With and Without Itraconazole [Part 1], Phenytoin [Part 2], or Paroxetine [Part 3]
Measured: Part 1 and Part 3, predose and up to 120 hours postdose; Part 2, predose and up to 96 hours postdose
Apparent Clearance (CL/F) of Poziotinib Following Poziotinib Administration With and Without Itraconazole [Part 1], Phenytoin [Part 2], or Paroxetine [Part 3]
Measured: Part 1 and Part 3, predose and up to 120 hours postdose; Part 2, predose and up to 96 hours postdose
Time to Maximum Observed Concentration (Tmax) for Poziotinib and Metabolites (M1 and M2) Following Poziotinib Administration With and Without Itraconazole [Part 1], Phenytoin [Part 2], or Paroxetine [Part 3]
Measured: Part 1 and Part 3, predose and up to 120 hours postdose; Part 2, predose and up to 96 hours postdose
Secondary outcomes (4)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Screening, and up to 14 days post last dose of Poziotinib
Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters From Baseline
Clinical laboratory parameters include tests of hematology, chemistry, coagulation, and urinalysis.
Measured: Screening, and up to 14 days post last dose of Poziotinib
Number of Participants With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Findings From Baseline
Measured: Screening, and up to 14 days post last dose of Poziotinib
Number of Participants With Clinically Significant Changes in Vital Signs From Baseline
Vital signs include body temperature, respiratory rate, blood pressure, and heart rate.
Measured: Screening, and up to 14 days post last dose of Poziotinib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start8 Apr 2021
- Primary completion30 Jun 2021
- Study completion17 Aug 2021
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shanta Chawla, MD, Study director, Spectrum Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981704
- Sponsor's protocol ID
- SPI-POZ-103
- Status last verified
- Sep 2021
- First submitted
- 23 Jun 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Part, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Multiple Doses of Itraconazole, Phenytoin, and Paroxetine on the Single-Dose Pharmacokinetics of Poziotinib in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04981704
- Acronym / sponsor ID
- SPI-POZ-103
- Conditions
- Healthy
- Keywords
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 17 Aug 2021 (actual)
- First posted
- 29 Jul 2021 (actual)
- 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.
The purpose of the study is to evaluate the effect of multiple-doses of itraconazole, phenytoin and paroxetine on the single-dose pharmacokinetics (PK) of poziotinib in healthy adult participants.
Detailed description
This is a three-part study. Participants will be enrolled in Part 1 (Effects of Itraconazole), Part 2 (Effects of Phenytoin), or Part 3 (Effects of Paroxetine) on the Pharmacokinetics of Poziotinib. Each part will be an open-label, fixed-sequence, 2-period study and may be conducted concurrently. For each study part, participants will be housed on Day -1 of Treatment Period 1 in the Clinical Research Unit (CRU) and will remain confined in the CRU until after the last scheduled blood draw and/or study procedures in Treatment Period 2. In each part, there will be a washout period of at least 8 days between poziotinib doses.
A total of 75 (25 in each part) healthy, adult male and female participants will be enrolled targeting a female/male ratio greater than or equal to (≥) 1:3 in each study part.
In part 1, CYP2D6 extensive metabolizers will be primarily enrolled with a goal of enrolling at least 2 CYP2D6 poor metabolizers. In Parts 2 and 3, only CYP2D6 extensive metabolizers will be enrolled. In Part 2, CYP2C9 and CYP2C19 poor metabolizers will be excluded.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Itraconazole/Poziotinib Drug-drug interaction (DDI) | Experimental | Drug: Poziotinib, Drug: ItraconazoleOn Day 1 of Treatment period 1, a single oral dose of 8 milligrams (mg) poziotinib will be administered. On Day 1 of Treatment Period 2, 200 mg itraconazole oral solution will be administered twice a day (BID) followed by 200 mg itraconazole oral solution once daily (QD) for 7 consecutive days (Day 2 to Day 8) with a single oral dose of 8 mg poziotinib coadministered on Day 4. |
| Part 2: Phenytoin/Poziotinib DDI | Experimental | Drug: Poziotinib, Drug: PhenytoinOn Day 1 of Treatment period 1, a single oral dose of 16 mg poziotinib will be administered. In treatment period 2, an oral dose of 100 mg phenytoin will be administered three times daily (TID) for 17 consecutive days (Day 1 to Day 17) with a single oral dose of 16 mg poziotinib coadministered on Day 14. |
| Part 3: Paroxetine/Poziotinib DDI | Experimental | Drug: Poziotinib, Drug: ParoxetineOn Day 1 of Treatment Period 1, a single oral dose of 8 mg poziotinib will be administered. On Day 1 and Day 2 of Treatment Period 2, an oral dose of 20 mg paroxetine will be administered BID followed by 20 mg paroxetine QD for 9 consecutive days (Day 3 to Day 11) with a single oral dose of 8 mg poziotinib coadministered on Day 7. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy, adult, male or female (of non-childbearing potential only), 18-55 years of age.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilogram per meter square (kg/m^2) at screening, and a minimum weight of 50.0 kg and a maximum weight of 100.0 kg at screening.
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study.
- Medically healthy with no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs, and laboratory evaluations.
- Female must be of non-childbearing potential only and must have undergone a sterilization procedure at least 6 months prior to the first dosing, or
Key exclusion criteria (28 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the PI (or designee).
- History of a developing or established acute event or infection in the prior 2 weeks to screening.
- History of significant hypersensitivity, or idiosyncratic reaction to poziotinib, itraconazole, phenytoin, paroxetine, or related drugs, food, or other substances.
- Any surgical or medical condition within 6 months prior to first dosing that may potentially alter absorption, distribution, metabolism or excretion of the study drugs, in the opinion of the PI (or designee).
- History or presence of alcoholism or drug/chemical abuse within 2 years prior to check-in.
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 |
|---|---|---|
| PoziotinibPoziotinib Tablets | Drug | Part 1: Itraconazole/Poziotinib Drug-drug interaction (DDI), Part 2: Phenytoin/Poziotinib DDI, Part 3: Paroxetine/Poziotinib DDI |
| ItraconazoleItraconazole Oral solution | Drug | Part 1: Itraconazole/Poziotinib Drug-drug interaction (DDI) |
| PhenytoinPhenytoin Capsules | Drug | Part 2: Phenytoin/Poziotinib DDI |
| ParoxetineAlso: Paxil ®Paroxetine Tablets | Drug | Part 3: Paroxetine/Poziotinib DDI |
Primary outcome
Area Under the Curve (AUC) of Poziotinib and Metabolites (M1 and M2) Following Poziotinib Administrations With and Without Itraconazole [Part 1], Phenytoin [Part 2], or Paroxetine [Part 3]
Time frame: Part 1 and Part 3, predose and up to 120 hours postdose; Part 2, predose and up to 96 hours postdose
Maximum Observed Concentration (Cmax) of Poziotinib and Metabolites (M1 and M2) Following Poziotinib Administration With and Without Itraconazole [Part 1], Phenytoin [Part 2], or Paroxetine [Part 3]
Time frame: Part 1 and Part 3, predose and up to 120 hours postdose; Part 2, predose and up to 96 hours postdose
Apparent Clearance (CL/F) of Poziotinib Following Poziotinib Administration With and Without Itraconazole [Part 1], Phenytoin [Part 2], or Paroxetine [Part 3]
Time frame: Part 1 and Part 3, predose and up to 120 hours postdose; Part 2, predose and up to 96 hours postdose
Time to Maximum Observed Concentration (Tmax) for Poziotinib and Metabolites (M1 and M2) Following Poziotinib Administration With and Without Itraconazole [Part 1], Phenytoin [Part 2], or Paroxetine [Part 3]
Time frame: Part 1 and Part 3, predose and up to 120 hours postdose; Part 2, predose and up to 96 hours postdose
4 secondary outcomes
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Screening, and up to 14 days post last dose of Poziotinib
Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters From Baseline
Time frame: Screening, and up to 14 days post last dose of Poziotinib
Number of Participants With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Findings From Baseline
Time frame: Screening, and up to 14 days post last dose of Poziotinib
Number of Participants With Clinically Significant Changes in Vital Signs From Baseline
Time frame: Screening, and up to 14 days post last dose of Poziotinib
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 5 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Shanta Chawla, MD study director
Spectrum Pharmaceuticals, Inc
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 Poziotinib, Itraconazole and Phenytoin in people with Healthy, run by Spectrum Pharmaceuticals, Inc 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 11 inclusion and 28 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 5 Sep 2021. 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 (AUC) of Poziotinib and Metabolites (M1 and M2) Following Poziotinib Administrations With and Without Itraconazole [Part 1], Phenytoin [Part 2], or Paroxetine [Part 3] (time frame: Part 1 and Part 3, predose and up to 120 hours postdose; Part 2, predose and up to 96 hours postdose). The study lists 4 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 5 Sep 2021.