HealthyPhase 1NCT02307461
Bioequivalence of Duvelisib and Food Effect on Pharmacokinetics of IPI-145
A Phase 1 study testing IPI-145 (duvelisib) and IPI-145 in people with Healthy, run by SecuraBio at 1 site in United States.
Trial summary
To Evaluate the Bioequivalence of the two formulations of IPI-145 and the Effect of Food on the Pharmacokinetics of IPI-145 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IPI-145 (duvelisib) and IPI-145
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Sep 2015
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men or women of non-child bearing potential between 18-50 years of age
- Body Mass Index (BMI): 18.0 - 32.0 kg/m2.
- Healthy subjects: in good health, determined by no clinically significant findings from clinical evaluations
- Provided written informed consent prior to any study specific procedures
Who cannot join
- Women of childbearing potential
- Healthy subjects: positive screening test for hepatitis B surface antigen, hepatitis C antibody, or HIV-1/HIV-2 antibodies
- ECG at screening showing QTcF ≥ 450 msec
- Evidence of clinically significant medical conditions
- History of gastrointestinal disease or surgery that may affect drug absorption
- Positive T-Spot (tuberculosis)TB test at screening
- Any active infection at the time of screening or admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, 2-Part Study to Evaluate the Bioequivalence of the Duvelisib Marker-Image Formulation to the Duvelisib Clinical-Trial Formulation and to Assess the Effect of Food on the Pharmacokinetics of IP Duvelisib in Healthy Adult Subjects
To Evaluate the Bioequivalence of the two formulations of IPI-145 and the Effect of Food on the Pharmacokinetics of IPI-145
Read the detailed description
This Phase 1, randomized, open-label study of IPI-145 will be conducted in 2 parts.
Part 1 will be conducted in 2 cohorts. Cohort 1 will consist of 32 healthy subjects, and Cohort 2 will consist of 52 healthy subjects. Subjects in each cohort will receive 2 doses of IPI under fasted conditions in a 2-period, 2-sequence crossover design. Dosing in Period 1 and Period 2 will be separated by at least 7 days.
Part 2 is a 2-period, 2-sequence crossover design to assess the effect of a high-fat meal on the PK of the IPI-145 in 20 subjects. Subjects will receive single oral doses under fed (high-fat meal) and fasted conditions, separated by at least 7 days.
- Conditions
- Healthy
- Being tested
- IPI-145 (duvelisib), IPI-145
- Keywords
- Phase 1, Bioequivalence, Pharmacokinetics, Food, Healthy Adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPI-145 (duvelisib)Drug
High single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) high single oral dose
IPI-145Drug
Low single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) low single oral dose
IPI-145Drug
High single oral dose IPI-145 test formulation (capsule) with a high-fat meal and without food
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Cohort 1 | Experimental | IPI-145 test formulation (capsule) high single dose and IPI-145 reference formulation (capsule) high single dose Receives: Drug: IPI-145 (duvelisib) |
| Part 1 Cohort 2 | Experimental | IPI-145 test formulation (capsule) low single dose and IPI-145 reference formulation (capsule) low single dose Receives: Drug: IPI-145 |
| Part 2 Cohort 3 | Experimental | IPI-145 test formulation (capsule) high single dose administered under fasted and fed conditions Receives: Drug: IPI-145 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of bioequivalence of the IPI-145 test and reference formulations
Measured: 24 Hours
Pharmacokinetic Parameter (AUClast ) of IPI-145
Measured: Over 24 hours
Pharmacokinetic Parameter (AUCinf ) of IPI-145
Measured: Over 24 hours
Pharmacokinetic Parameter (Cmax) of IPI-145
Measured: Over 24 hours
Secondary outcomes (1)
Incidence of adverse events following administration of IPI-145
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionAug 2015
- Study completionSep 2015
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- SecuraBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hagop Youssoufian, MD, Study chair, Verastem, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307461
- Sponsor's protocol ID
- IPI-145-15
- Status last verified
- Mar 2021
- First submitted
- 18 Nov 2014
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, 2-Part Study to Evaluate the Bioequivalence of the Duvelisib Marker-Image Formulation to the Duvelisib Clinical-Trial Formulation and to Assess the Effect of Food on the Pharmacokinetics of IP Duvelisib in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02307461
- Acronym / sponsor ID
- IPI-145-15
- Conditions
- Healthy
- Keywords
- Phase 1, Bioequivalence, Pharmacokinetics, Food, Healthy Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- SecuraBioIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Dec 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.
To Evaluate the Bioequivalence of the two formulations of IPI-145 and the Effect of Food on the Pharmacokinetics of IPI-145
Detailed description
This Phase 1, randomized, open-label study of IPI-145 will be conducted in 2 parts.
Part 1 will be conducted in 2 cohorts. Cohort 1 will consist of 32 healthy subjects, and Cohort 2 will consist of 52 healthy subjects. Subjects in each cohort will receive 2 doses of IPI under fasted conditions in a 2-period, 2-sequence crossover design. Dosing in Period 1 and Period 2 will be separated by at least 7 days.
Part 2 is a 2-period, 2-sequence crossover design to assess the effect of a high-fat meal on the PK of the IPI-145 in 20 subjects. Subjects will receive single oral doses under fed (high-fat meal) and fasted conditions, separated by at least 7 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 Cohort 1 | Experimental | Drug: IPI-145 (duvelisib)IPI-145 test formulation (capsule) high single dose and IPI-145 reference formulation (capsule) high single dose |
| Part 1 Cohort 2 | Experimental | Drug: IPI-145IPI-145 test formulation (capsule) low single dose and IPI-145 reference formulation (capsule) low single dose |
| Part 2 Cohort 3 | Experimental | Drug: IPI-145IPI-145 test formulation (capsule) high single dose administered under fasted and fed conditions |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men or women of non-child bearing potential between 18-50 years of age
- Body Mass Index (BMI): 18.0 - 32.0 kg/m2.
- Healthy subjects: in good health, determined by no clinically significant findings from clinical evaluations
- Provided written informed consent prior to any study specific procedures
Key exclusion criteria (7 listed)
- Women of childbearing potential
- Healthy subjects: positive screening test for hepatitis B surface antigen, hepatitis C antibody, or HIV-1/HIV-2 antibodies
- ECG at screening showing QTcF ≥ 450 msec
- Evidence of clinically significant medical conditions
- History of gastrointestinal disease or surgery that may affect drug absorption
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 |
|---|---|---|
| IPI-145 (duvelisib)High single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) high single oral dose | Drug | Part 1 Cohort 1 |
| IPI-145Low single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) low single oral dose | Drug | Part 1 Cohort 2 |
| IPI-145High single oral dose IPI-145 test formulation (capsule) with a high-fat meal and without food | Drug | Part 2 Cohort 3 |
Primary outcome
Assessment of bioequivalence of the IPI-145 test and reference formulations
Time frame: 24 Hours
Pharmacokinetic Parameter (AUClast ) of IPI-145
Time frame: Over 24 hours
Pharmacokinetic Parameter (AUCinf ) of IPI-145
Time frame: Over 24 hours
Pharmacokinetic Parameter (Cmax) of IPI-145
Time frame: Over 24 hours
1 secondary outcome
Incidence of adverse events following administration of IPI-145
Time frame: 7 weeks
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 Mar 2021.
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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.
Hagop Youssoufian, MD study chair
Verastem, 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 IPI-145 (duvelisib) and IPI-145 in people with Healthy, run by SecuraBio 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 4 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 17 Mar 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?
Assessment of bioequivalence of the IPI-145 test and reference formulations (time frame: 24 Hours). 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 17 Mar 2021.