HealthyPhase 1NCT01836861
IPI-145 ADME and Absolute Bioavailability Study
A Phase 1 study testing IPI-145 in people with Healthy, run by SecuraBio at 1 site in Netherlands.
Trial summary
This is an open-label, 2-period, absorption, distribution, metabolism and excretion (ADME) and absolute bioavailability study in 6 healthy adult male subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IPI-145
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2013to May 2013
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males, between 18 and 45 years of age, inclusive Body Mass Index (BMI) : 18.0-30.0 kg/m2
- In good health, determined by no clinically significant findings from medical history, physical examination (Check-in), 12-lead ECG, and vital signs
- Provision of signed and dated, written informed consent prior to any study specific procedures
Who cannot join
- Evidence of clinically significant medical conditions
- History of gastrointestinal surgery that may affect drug absorption
- Positive or indeterminate QuantiFERON-TB Gold test at screening
- Any active infection at the time of screening or admission
- Participation in another ADME study with a radiation burden >0.1 mSv in the period of 1 year before screening
- Irregular defecation pattern (less than once per 2 days)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study of the Absorption, Distribution, Metabolism and Excretion of 14C-Labeled IPI-145 and the Absolute Bioavailability of IPI-145 in Healthy Subjects
This is an open-label, 2-period, absorption, distribution, metabolism and excretion (ADME) and absolute bioavailability study in 6 healthy adult male subjects.
Read the detailed description
In Period 1, subjects will receive a single oral dose of 25 mg IPI-145, followed by a 15-minute IV infusion of approximately 2.8 μg 14C-IPI-145 containing 14.8 kBq of radioactivity.
In Period 2, the same subjects will receive a single dose of 25 mg 14C-IPI-145 as an oral suspension, containing approximately 3.15 MBq of radioactivity.
There will be a washout period of at least 14 days between Period 1 and Period 2.
- Conditions
- Healthy
- Being tested
- IPI-145
- Keywords
- Phase I, healthy male volunteers, ADME, Bioavailability, PI3K inhibitor, Absorption, Distribution, Metabolism, Excretion, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPI-145Drug
Intravenous infusion: approximately 2.8 μg IPI-145 containing 14.8 kBq of radioactivity; Oral suspension: 25 mg IPI-145 containing approximately 3.15 MBq of radioactivity; Oral capsule: 25 mg IPI-145
| Study group | Role | What they receive |
|---|---|---|
| IPI-145 and [14C] IPI-145 | Experimental | Not described Receives: Drug: IPI-145 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters (AUC) of IPI-145 in plasma
Measured: over 48 hours
PK parameters (AUC) and radioactivity excreted in urine and feces
Measured: over 144 hours
PK parameters (Cmax) of IPI-145 in plasma
Measured: over 48 hours
PK parameters (t1/2) of IPI-145 in plasma
Measured: over 48 hours
PK parameters (Cmax) and radioactivity excreted in urine and feces
Measured: over 144 hours
PK parameters (t1/2) and radioactivity excreted in urine and feces
Measured: over 144 hours
Secondary outcomes (1)
Number of participants with adverse events following a single dose administration of IPI-145
Measured: over 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2013
- Study completionMay 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT01836861
- Sponsor's protocol ID
- IPI-145-05
- Other IDs
- 2012-005425-75
- Status last verified
- Mar 2021
- First submitted
- 1 Apr 2013
- 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 Study of the Absorption, Distribution, Metabolism and Excretion of 14C-Labeled IPI-145 and the Absolute Bioavailability of IPI-145 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01836861
- Acronym / sponsor ID
- IPI-145-05
- Conditions
- Healthy
- Keywords
- Phase I, healthy male volunteers, ADME, Bioavailability, PI3K inhibitor, Absorption, Distribution, Metabolism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- SecuraBioIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 22 Apr 2013 (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 an open-label, 2-period, absorption, distribution, metabolism and excretion (ADME) and absolute bioavailability study in 6 healthy adult male subjects.
Detailed description
In Period 1, subjects will receive a single oral dose of 25 mg IPI-145, followed by a 15-minute IV infusion of approximately 2.8 μg 14C-IPI-145 containing 14.8 kBq of radioactivity.
In Period 2, the same subjects will receive a single dose of 25 mg 14C-IPI-145 as an oral suspension, containing approximately 3.15 MBq of radioactivity.
There will be a washout period of at least 14 days between Period 1 and Period 2.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPI-145 and [14C] IPI-145 | Experimental | Drug: IPI-145 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males, between 18 and 45 years of age, inclusive Body Mass Index (BMI) : 18.0-30.0 kg/m2
- In good health, determined by no clinically significant findings from medical history, physical examination (Check-in), 12-lead ECG, and vital signs
- Provision of signed and dated, written informed consent prior to any study specific procedures
Key exclusion criteria (6 listed)
- Evidence of clinically significant medical conditions
- History of gastrointestinal surgery that may affect drug absorption
- Positive or indeterminate QuantiFERON-TB Gold test at screening
- Any active infection at the time of screening or admission
- Participation in another ADME study with a radiation burden >0.1 mSv in the period of 1 year before screening
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-145Intravenous infusion: approximately 2.8 μg IPI-145 containing 14.8 kBq of radioactivity; Oral suspension: 25 mg IPI-145 containing approximately 3.15 MBq of radioactivity; Oral capsule: 25 mg IPI-145 | Drug | IPI-145 and [14C] IPI-145 |
Primary outcome
PK parameters (AUC) of IPI-145 in plasma
Time frame: over 48 hours
PK parameters (AUC) and radioactivity excreted in urine and feces
Time frame: over 144 hours
PK parameters (Cmax) of IPI-145 in plasma
Time frame: over 48 hours
PK parameters (t1/2) of IPI-145 in plasma
Time frame: over 48 hours
PK parameters (Cmax) and radioactivity excreted in urine and feces
Time frame: over 144 hours
PK parameters (t1/2) and radioactivity excreted in urine and feces
Time frame: over 144 hours
1 secondary outcome
Number of participants with adverse events following a single dose administration of IPI-145
Time frame: over 4 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 in people with Healthy, run by SecuraBio 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 3 inclusion and 6 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 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?
PK parameters (AUC) of IPI-145 in plasma (time frame: over 48 hours). The study lists 6 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.