Healthy VolunteerPhase 1NCT01408316
Study of the Pharmacokinetics and Pharmacodynamics of Crystalline PX-866 Tablets and Amorphous PX-866 Capsules in Healthy Volunteers
A Phase 1 study testing PX-866 in people with Healthy Volunteer, run by Cascadian Therapeutics Inc. at 1 site in United States.
Trial summary
This is a two part study designed to evaluate the PK profile of PX-866 capsules versus tablets, and to evaluate the effect of food on the PK of PX-866 tablets only in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- PX-866
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jan 2012
- 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
- Between 18 and 65 years of age (inclusive
- Able to communicate well with study staff and to read, understand, sign and date the written informed consent form (ICF) for this study.
- Must be willing to use double barrier contraception until 90 days after last dose of study drug.
- If female and of child bearing potential, volunteer must have a negative serum pregnancy test at screening and on Day 1 or Day 1.
- Body mass index (BMI) is between 18 and 32 kg/m2 (inclusive) at screening.
- Judged by the investigator to be in good health for the purposes of this study, based on results of medical history, physical examination, ECG and laboratory testing which show no major or clinically significant findings at pre dose on Day 1.
Show all 11Show fewer
- Has normal hepatobiliary enzyme and bilirubin (total and conjugated) results on Day 1 and/or on Day 1.
- Has normal hemoglobin, hematocrit, absolute neutrophil count, absolute lymphocyte count and platelet count on Day 1 or Day 1.
- Blood pressure is between 95 and 140 mm Hg (inclusive) systolic, 50 to 90 mm Hg (inclusive) diastolic, and pulse rate (determined by vital signs measurement) is between 40 and 100 beats per minute (inclusive) at screening and pre dose on Day 1.
- Ability and intent to comply with all requirements of the study.
- Signed ICF prior to the conduct of any study procedure.
Who cannot join
- History of any illness or condition that, in the opinion of the investigator, may compromise the integrity of the study data or pose a significant risk in administering study drug to the subject. This may include but is not limited to a history of relevant drug allergies; history of cardiovascular or central nervous system disease; history or presence of clinically significant pathology; or history of mental illness.
- Use of prescription medication (with systemic exposure) within 14 days prior to Day 1, or likelihood of needing to use such medication during the course of study participation.
- Use of over the counter products with systemic exposure (e.g., oral medications, herbal preparations, dietary supplements - excepting acetaminophen at less than two gm per day and vitamin supplements at or near recommended daily allowances) within 7 days prior to Day 1, or likelihood of needing to use such products during the course of study participation.
- Use of any known inhibitors or inducers of CYP3A4, (e.g., St. John's Wort, ginkgo biloba, garlic supplements, grapefruit or grapefruit juice, apple juice, or orange juice) within 7 days prior to Day 1.
- Typically consumes more than two units of alcoholic beverages per day or more than 14 units per week (one unit of alcohol being one pint [568 mL] of beer or lager, one glass [125 mL] of wine, one 25 mL shot of 40% spirits).
- Has consumed alcohol within 72 hours prior to dosing on Day 1.
Show all 20Show fewer
- Typically consumes more than five 8 ounce servings per day of coffee, cola, or other caffeinated beverages or products with similar amounts of caffeine.
- Has consumed caffeinated beverages or products within 48 hours prior to Day 1 dosing.
- Has history of drug or alcohol abuse or addiction (by DSM IV criteria) within 2 years prior to Day 1.
- Has used tobacco or other nicotine containing product within 6 months prior to Day 1.
- Has positive urine drug screen for opiates, methadone, cannabinoids, cocaine, amphetamines/methamphetamines, barbiturates, benzodiazepines, cotinine or alcohol at the screening visit or on Day 1.
- Has participated in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 half lives (whichever is longer) prior to Day 1.
- Has been dosed with PX 866 previously.
- Has donated blood or had a significant loss of blood within 56 days prior to Day 1 or has donated more than one unit of plasma within 7 days prior to Day 1.
- Has a positive result at screening for hepatitis B antigen, hepatitis C virus antibody, human immunodeficiency virus 1 antibody or human immunodeficiency virus 2 antibody.
- Has had an illness within 5 days prior to Day 1.
- Is female and pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug.
- Has a history of gall bladder disease, bowel pattern of ≥ 2 stools per day or intermittent diarrhea, or alteration of gastrointestinal anatomy that, in the opinion of the investigator, may alter absorption or elimination of PX 866.
- Has QTcF > 450 msec on any ECG prior to Day 1 dosing.
- In estimation of the investigator, volunteer has significant numbers of premature atrial or ventricular premature beats or other significant ECG findings, seen on continuous ECG data acquired between admission and enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Clinical Development NW
Tacoma, Washington, 98418
About this study
Official title: A Phase 1 Two-way Cross-over Study of the Pharmacokinetics and Pharmacodynamics of Crystalline PX-866 Tablets and Amorphous PX-866 Capsules Administered in the Fasting State, and of Crystalline PX-866 Tablets Administered Fed and Fasting, in Healthy Subjects
This is a two part study designed to evaluate the PK profile of PX-866 capsules versus tablets, and to evaluate the effect of food on the PK of PX-866 tablets only in healthy volunteers.
Read the detailed description
This is a two part, Phase 1, open label, cross over study designed to evaluate the PK profile of crystalline PX-866 tablets relative to that of amorphous PX-866 capsules and to evaluate the effect of administration with food on the PK of crystalline PX-866 tablets in healthy volunteers.
- Conditions
- Healthy Volunteer
- Being tested
- PX-866
- Keywords
- Healthy Volunteer, PX-866, PI3K Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PX-866Drug
Volunteers in part 1 of the study will receive two single dose 8 mg treatments of PX-866 (one each of crystalline PX-866 tablets and amorphous PX-866 capsules) in Periods A and B, separated by at least seven days. Volunteers in part 2 of the study will receive two single dose 6 mg treatments of PX-866 (crystalline PX-866 tablets administered in either fed or fasted state), in Periods C and D, separated by at least seven days.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (Crystalline vs. Amorphous) | Experimental | Volunteers in part 1 of the study will initially receive either crystalline PX-866 tablets or amorphous PX-866 capsules, then after seven days, the same volunteers will respectively cross-over to receive the alternate amorphous PX-866 capsules or crystalline PX-866 tablets. Receives: Drug: PX-866 |
| Part 2 (Crystalline Food Effect) | Experimental | Volunteers in part 2 of the study will receive two single dose treatments of PX-866 crystalline tablets initially administered in either fed or fasted state, then after at least seven days, the same volunteers will respectively cross-over to receive PX-866 tablets in the alternate fed or fasted state. Receives: Drug: PX-866 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - Cmax, Tmax, AUC, and T1/2 of plasma concentrations of PX-866 and PX-866 metabolites
Part 1: To evaluate and compare the pharmacokinetic (PK) profiles (of PX 866 and metabolites) after administration of crystalline PX 866 tablets and amorphous PX 866 capsules.
Part 2: To evaluate the effect of food on the PK profile of crystalline PX 866 tablets.
Measured: 9 days
Secondary outcomes (1)
Incidence and severity of adverse events, vital signs, clinical laboratory, and ECG changes or abnormalities
To evaluate the safety and tolerability of crystalline PX-866 tablets.
Measured: 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cascadian Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard Quint, MD, Principal investigator, Comprehensive Clinical Development NW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408316
- Sponsor's protocol ID
- PX-866-006
- Status last verified
- Mar 2012
- First submitted
- 27 Jul 2011
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Two-way Cross-over Study of the Pharmacokinetics and Pharmacodynamics of Crystalline PX-866 Tablets and Amorphous PX-866 Capsules Administered in the Fasting State, and of Crystalline PX-866 Tablets Administered Fed and Fasting, in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01408316
- Acronym / sponsor ID
- PX-866-006
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, PX-866, PI3K Inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Cascadian Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 3 Aug 2011 (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 is a two part study designed to evaluate the PK profile of PX-866 capsules versus tablets, and to evaluate the effect of food on the PK of PX-866 tablets only in healthy volunteers.
Detailed description
This is a two part, Phase 1, open label, cross over study designed to evaluate the PK profile of crystalline PX-866 tablets relative to that of amorphous PX-866 capsules and to evaluate the effect of administration with food on the PK of crystalline PX-866 tablets in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 (Crystalline vs. Amorphous) | Experimental | Drug: PX-866Volunteers in part 1 of the study will initially receive either crystalline PX-866 tablets or amorphous PX-866 capsules, then after seven days, the same volunteers will respectively cross-over to receive the alternate amorphous PX-866 capsules or crystalline PX-866 tablets. |
| Part 2 (Crystalline Food Effect) | Experimental | Drug: PX-866Volunteers in part 2 of the study will receive two single dose treatments of PX-866 crystalline tablets initially administered in either fed or fasted state, then after at least seven days, the same volunteers will respectively cross-over to receive PX-866 tablets in the alternate fed or fasted state. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Between 18 and 65 years of age (inclusive
- Able to communicate well with study staff and to read, understand, sign and date the written informed consent form (ICF) for this study.
- Must be willing to use double barrier contraception until 90 days after last dose of study drug.
- If female and of child bearing potential, volunteer must have a negative serum pregnancy test at screening and on Day 1 or Day 1.
- Body mass index (BMI) is between 18 and 32 kg/m2 (inclusive) at screening.
Key exclusion criteria (20 listed)
- History of any illness or condition that, in the opinion of the investigator, may compromise the integrity of the study data or pose a significant risk in administering study drug to the subject. This may include but is not limited to a history of relevant drug allergies; history of cardiovascular or central nervous system disease; history or presence of clinically significant pathology; or history of mental illness.
- Use of prescription medication (with systemic exposure) within 14 days prior to Day 1, or likelihood of needing to use such medication during the course of study participation.
- Use of over the counter products with systemic exposure (e.g., oral medications, herbal preparations, dietary supplements - excepting acetaminophen at less than two gm per day and vitamin supplements at or near recommended daily allowances) within 7 days prior to Day 1, or likelihood of needing to use such products during the course of study participation.
- Use of any known inhibitors or inducers of CYP3A4, (e.g., St. John's Wort, ginkgo biloba, garlic supplements, grapefruit or grapefruit juice, apple juice, or orange juice) within 7 days prior to Day 1.
- Typically consumes more than two units of alcoholic beverages per day or more than 14 units per week (one unit of alcohol being one pint [568 mL] of beer or lager, one glass [125 mL] of wine, one 25 mL shot of 40% spirits).
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 |
|---|---|---|
| PX-866Volunteers in part 1 of the study will receive two single dose 8 mg treatments of PX-866 (one each of crystalline PX-866 tablets and amorphous PX-866 capsules) in Periods A and B, separated by at least seven days. Volunteers in part 2 of the study will receive two single dose 6 mg treatments of PX-866 (crystalline PX-866 tablets administered in either fed or fasted state), in Periods C and D, separated by at least seven days. | Drug | Part 1 (Crystalline vs. Amorphous), Part 2 (Crystalline Food Effect) |
Primary outcome
Pharmacokinetics - Cmax, Tmax, AUC, and T1/2 of plasma concentrations of PX-866 and PX-866 metabolites
Time frame: 9 days
Part 1: To evaluate and compare the pharmacokinetic (PK) profiles (of PX 866 and metabolites) after administration of crystalline PX 866 tablets and amorphous PX 866 capsules. Part 2: To evaluate the effect of food on the PK profile of crystalline PX 866 tablets.
1 secondary outcome
Incidence and severity of adverse events, vital signs, clinical laboratory, and ECG changes or abnormalities
Time frame: 16 days
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 May 2018.
Related trials for Healthy Volunteer
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.
Howard Quint, MD principal investigator
Comprehensive Clinical Development NW
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 PX-866 in people with Healthy Volunteer, run by Cascadian Therapeutics 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 20 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 May 2018. 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?
Pharmacokinetics - Cmax, Tmax, AUC, and T1/2 of plasma concentrations of PX-866 and PX-866 metabolites (time frame: 9 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 17 May 2018.