MalignanciesPhase 1NCT02521389
Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Various Formulations and Doses of PWT-143
A Phase 1 study testing PWT-143 in people with Malignancies, run by MEI Pharma, Inc. at 1 site in United Kingdom.
Trial summary
This single center first in human (FIH) study will comprise 2 parts; Part 1 will consist of 3 sequential dose groups (Groups A, B and C) and Part 2 will consist of 1 dose group (Group A). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Malignancies
- What is being tested?
- PWT-143
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jun 2015to 24 Feb 2017
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males
- Age 18 to 65 years of age
- Body mass index of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Part 2 only: Must be able to consume all food items in a standard high fat breakfast and/or have no conditions or surgery (eg, cholecystectomy) that could affect their ability to eat the high fat breakfast
- Must be willing and able to communicate and participate in the whole study
- Must be willing to provide voluntary written informed consent before performance of any study-related procedure that is not part of normal medical care
- Must agree to use an adequate method of contraception
Who cannot join
- Healthy males
- Age 18 to 65 years of age
- Body mass index of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Part 2 only: Must be able to consume all food items in a standard high fat breakfast and/or have no conditions or surgery (eg, cholecystectomy) that could affect their ability to eat the high fat breakfast
- Must be willing and able to communicate and participate in the whole study
- Must be willing to provide voluntary written informed consent before performance of any study-related procedure that is not part of normal medical care
- Must agree to use an adequate method of contraception
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Clinical
Ruddington, Nottingham, NG11 6JS
About this study
Official title: Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of Various Formulations of PWT-143 in Healthy Subjects
This single center first in human (FIH) study will comprise 2 parts; Part 1 will consist of 3 sequential dose groups (Groups A, B and C) and Part 2 will consist of 1 dose group (Group A). There will be an option to include 2 additional dose groups in Part 1 (Groups D and E) to assess alternative dose levels or formulations, if required.
In each study part, each subject will receive a single dose of investigational medicinal product PWT-143 in each of 2 study periods (total of 2 single doses).
Read the detailed description
This first-in-human study will comprise 2 parts. In each part, each subject will receive a single dose of investigational medicinal product (IMP) in each of 2 study periods (total of 2 single doses).
Part 1 (Single Ascending Dose) This is an open-label, single dose design. It is planned to enroll up to 3 sequential groups (Groups A, B and C), comprising 3, 6 and 6 subjects, respectively, with 2 optional additional groups (Groups D and E), each comprising 6 subjects, to assess alternative dose levels or formulations (described below), if required.
The starting dose, dose increments and dose range are based on available pre-clinical data. Current planned dose levels are: 10, 30, 60, 90 and 150 mg (dose levels 1, 2, 3, 4 and 5, respectively); however, doses above 10 mg will be selected based on a review of emerging data from this study.
It is planned to use Formulation 1 for dose administration in Part 1 (Group A), selected from 3 test formulations. However, based on the exposure seen in the emerging data, an alternative formulation may be selected for dose comparison or escalation.
Part 2 (Food Effect Assessment) This is an open-label, randomised, single dose, 2-way crossover design to assess a selected formulation of PWT-143 in the fed and fasted states. Subjects will be administered a single dose of investigational medicinal product in the fed and fasted states across 2 study periods according to the randomisation schedule. There will be a minimum washout period for PWT-143 of 7 days between dose administrations in Periods 1 and 2.
It is planned that 1 group comprising 8 subjects will participate in Part 2. Subjects will be considered evaluable if they have received both treatments (ie, fed and fasted) and have completed safety assessments and PK sampling up to 24 h post-dose.
- Conditions
- Malignancies
- Being tested
- PWT-143
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PWT-143Drug
phosphatidylinositol-4,5-bisphosphate 3-kinase (PI3K) delta inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | 3 sequential groups (Groups A, B and C), comprising 3, 6 and 6 subjects, respectively, with 2 optional additional groups (Groups D and E), each comprising 6 subjects, to assess alternative dose levels or formulations (described below), if required. Receives: Drug: PWT-143 |
| Part 2 | Experimental | Single dose, 2-way crossover design to assess a selected formulation of PWT-143 in the fed and fasted states in 8 subjects. Receives: Drug: PWT-143 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with and types of Adverse Events
Measured: 5 months
Secondary outcomes (3)
Tmax (time from dosing at which Cmax is determined)
Measured: 5 months
Cmax (maximum observed plasma concentration)
Measured: 5 months
AUC (area under the concentration time curve)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study start29 Jun 2015
- Primary completion24 Feb 2017
- Study completion24 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalignanciesStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- MEI Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Responsible party
- Sponsor
- Investigators
- Pui Leung, MBChB, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521389
- Sponsor's protocol ID
- PWT-143
- Status last verified
- Aug 2017
- First submitted
- 4 Aug 2015
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Moreno O, Butler T, Zann V, Willson A, Leung P, Connor A. Safety, Pharmacokinetics, and Pharmacodynamics of ME-401, an Oral, Potent, and Selective Inhibitor of Phosphatidylinositol 3-Kinase P110delta, Following Single Ascending Dose Administration to Healthy Volunteers. Clin Ther. 2018 Nov;40(11):1855-1867. doi: 10.1016/j.clinthera.2018.09.006. Epub 2018 Oct 26.
PubMed 30458930
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of Various Formulations of PWT-143 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02521389
- Acronym / sponsor ID
- PWT-143
- Conditions
- Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- MEI Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Study start
- 29 Jun 2015 (actual)
- Primary completion
- 24 Feb 2017 (actual)
- Study completion
- 24 Feb 2017 (actual)
- First posted
- 13 Aug 2015 (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 single center first in human (FIH) study will comprise 2 parts; Part 1 will consist of 3 sequential dose groups (Groups A, B and C) and Part 2 will consist of 1 dose group (Group A). There will be an option to include 2 additional dose groups in Part 1 (Groups D and E) to assess alternative dose levels or formulations, if required.
In each study part, each subject will receive a single dose of investigational medicinal product PWT-143 in each of 2 study periods (total of 2 single doses).
Detailed description
This first-in-human study will comprise 2 parts. In each part, each subject will receive a single dose of investigational medicinal product (IMP) in each of 2 study periods (total of 2 single doses).
Part 1 (Single Ascending Dose) This is an open-label, single dose design. It is planned to enroll up to 3 sequential groups (Groups A, B and C), comprising 3, 6 and 6 subjects, respectively, with 2 optional additional groups (Groups D and E), each comprising 6 subjects, to assess alternative dose levels or formulations (described below), if required.
The starting dose, dose increments and dose range are based on available pre-clinical data. Current planned dose levels are: 10, 30, 60, 90 and 150 mg (dose levels 1, 2, 3, 4 and 5, respectively); however, doses above 10 mg will be selected based on a review of emerging data from this study.
It is planned to use Formulation 1 for dose administration in Part 1 (Group A), selected from 3 test formulations. However, based on the exposure seen in the emerging data, an alternative formulation may be selected for dose comparison or escalation.
Part 2 (Food Effect Assessment) This is an open-label, randomised, single dose, 2-way crossover design to assess a selected formulation of PWT-143 in the fed and fasted states. Subjects will be administered a single dose of investigational medicinal product in the fed and fasted states across 2 study periods according to the randomisation schedule. There will be a minimum washout period for PWT-143 of 7 days between dose administrations in Periods 1 and 2.
It is planned that 1 group comprising 8 subjects will participate in Part 2. Subjects will be considered evaluable if they have received both treatments (ie, fed and fasted) and have completed safety assessments and PK sampling up to 24 h post-dose.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: PWT-1433 sequential groups (Groups A, B and C), comprising 3, 6 and 6 subjects, respectively, with 2 optional additional groups (Groups D and E), each comprising 6 subjects, to assess alternative dose levels or formulations (described below), if required. |
| Part 2 | Experimental | Drug: PWT-143Single dose, 2-way crossover design to assess a selected formulation of PWT-143 in the fed and fasted states in 8 subjects. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy males
- Age 18 to 65 years of age
- Body mass index of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Part 2 only: Must be able to consume all food items in a standard high fat breakfast and/or have no conditions or surgery (eg, cholecystectomy) that could affect their ability to eat the high fat breakfast
- Must be willing and able to communicate and participate in the whole study
Key exclusion criteria (7 listed)
- Healthy males
- Age 18 to 65 years of age
- Body mass index of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Part 2 only: Must be able to consume all food items in a standard high fat breakfast and/or have no conditions or surgery (eg, cholecystectomy) that could affect their ability to eat the high fat breakfast
- Must be willing and able to communicate and participate in the whole study
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 |
|---|---|---|
| PWT-143phosphatidylinositol-4,5-bisphosphate 3-kinase (PI3K) delta inhibitor | Drug | Part 1, Part 2 |
Primary outcome
The number of participants with and types of Adverse Events
Time frame: 5 months
3 secondary outcomes
Tmax (time from dosing at which Cmax is determined)
Time frame: 5 months
Cmax (maximum observed plasma concentration)
Time frame: 5 months
AUC (area under the concentration time curve)
Time frame: 5 months
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 29 Aug 2017.
- Derived from this study: PubMed 30458930Moreno O, Butler T, Zann V, Willson A, Leung P, Connor A. Safety, Pharmacokinetics, and Pharmacodynamics of ME-401, an Oral, Potent, and Selective Inhibitor of Phosphatidylinositol 3-Kinase P110delta, Following Single Ascending Dose Administration to Healthy Volunteers. Clin Ther. 2018 Nov;40(11):1855-1867. doi: 10.1016/j.clinthera.2018.09.006. Epub 2018 Oct 26.
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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.
Pui Leung, MBChB principal investigator
Study Principal Investigator
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 PWT-143 in people with Malignancies, run by MEI Pharma, Inc. at 1 site in United Kingdom.
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 7 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 29 Aug 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 Kingdom. 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 number of participants with and types of Adverse Events (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02521389, which also lists 1 linked publication.
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 29 Aug 2017.