HealthyPhase 1DDINCT01947777
Phase 1 Study in Healthy Subjects to Evaluate the Effect of Rifampin on the Pharmacokinetics of IPI-145
A Phase 1 study testing IPI-145 and Rifampin in people with Healthy, run by SecuraBio at 1 site in United States.
Trial summary
To evaluate the effect of rifampin, a cytochrome P450 3A (CYP3A) inducer, on the pharmacokinetics (PK) of IPI-145; to assess the safety and tolerability of IPI-145 when administered with rifampin in healthy subjects 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 and Rifampin
- Type of treatment
- Pill or oral medicine
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men or women of non-childbearing potential between 18-50 years of age
- Body Mass Index (BMI): 18.0 - 32.0 kg/m2
- 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
- Evidence of clinically significant medical conditions
- History of gastrointestinal disease or surgery that may affect drug absorption
- Positive or indeterminate Tuberculosis -spot test at screening
- Any active infection at the time of screening or admission
- Consumption of any nutrients known to modulate cytochrome P450 enzyme activity within 14 days prior to administration of study drug, during the study, and until after discharge
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Single-Sequence, 2-Period Study to Evaluate the Effect of Rifampin (a CYP3A Inducer) on the Pharmacokinetics of IPI-145 in Healthy Subjects
To evaluate the effect of rifampin, a cytochrome P450 3A (CYP3A) inducer, on the pharmacokinetics (PK) of IPI-145; to assess the safety and tolerability of IPI-145 when administered with rifampin in healthy subjects
Read the detailed description
- In Treatment Period 1, subjects will receive a single 25 mg oral dose of IPI-145
- In Treatment Period 2, on Days 3-9, the same subjects will receive once daily (QD) oral doses of 600 mg rifampin; on Day 9, subjects will receive a single oral dose of 25 mg IPI-145 concomitantly administered with 600 mg of rifampin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPI-145Drug
25 mg oral capsule
RifampinDrug
2x 300 mg oral capsule
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters (AUC) of IPI-145 and its metabolite, IPI-656
Measured: Over 48 hours
Pharmacokinetic parameters (Cmax) of IPI-145 and its metabolite, IPI-656
Measured: Over 48 hours
Pharmacokinetic parameters (t1/2) of IPI-145 and its metabolite, IPI-656
Measured: Over 48 hours
Plasma concentrations of IPI-145 and its metabolite, IPI-656
Measured: Over 48 hours
Secondary outcomes (1)
Incidence of adverse events following administration of IPI-145, rifampin, and the combination.
Safety Findings
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2013
- Study completionDec 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
- 14 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
- NCT01947777
- Sponsor's protocol ID
- IPI-145-11
- Acronym
- DDI
- Status last verified
- Mar 2021
- First submitted
- 18 Sep 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, Single-Sequence, 2-Period Study to Evaluate the Effect of Rifampin (a CYP3A Inducer) on the Pharmacokinetics of IPI-145 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01947777
- Acronym / sponsor ID
- DDI / IPI-145-11
- Conditions
- Healthy
- Keywords
- Phase 1, Healthy subjects, DDI, CYP3A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- SecuraBioIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Sep 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.
To evaluate the effect of rifampin, a cytochrome P450 3A (CYP3A) inducer, on the pharmacokinetics (PK) of IPI-145; to assess the safety and tolerability of IPI-145 when administered with rifampin in healthy subjects
Detailed description
- In Treatment Period 1, subjects will receive a single 25 mg oral dose of IPI-145
- In Treatment Period 2, on Days 3-9, the same subjects will receive once daily (QD) oral doses of 600 mg rifampin; on Day 9, subjects will receive a single oral dose of 25 mg IPI-145 concomitantly administered with 600 mg of rifampin
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy men or women of non-childbearing potential between 18-50 years of age
- Body Mass Index (BMI): 18.0 - 32.0 kg/m2
- 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 (6 listed)
- Women of childbearing potential
- Evidence of clinically significant medical conditions
- History of gastrointestinal disease or surgery that may affect drug absorption
- Positive or indeterminate Tuberculosis -spot test at screening
- Any active infection at the time of screening or admission
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-14525 mg oral capsule | Drug | – |
| Rifampin2x 300 mg oral capsule | Drug | – |
Primary outcome
Pharmacokinetic parameters (AUC) of IPI-145 and its metabolite, IPI-656
Time frame: Over 48 hours
Pharmacokinetic parameters (Cmax) of IPI-145 and its metabolite, IPI-656
Time frame: Over 48 hours
Pharmacokinetic parameters (t1/2) of IPI-145 and its metabolite, IPI-656
Time frame: Over 48 hours
Plasma concentrations of IPI-145 and its metabolite, IPI-656
Time frame: Over 48 hours
1 secondary outcome
Incidence of adverse events following administration of IPI-145, rifampin, and the combination.
Time frame: 2 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 and Rifampin 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 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 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?
Pharmacokinetic parameters (AUC) of IPI-145 and its metabolite, IPI-656 (time frame: Over 48 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.