Hepatic ImpairmentPhase 1IPI-145-14NCT02095587
Duvelisib in Hepatically Impaired Subjects Compared to Healthy Subjects
A Phase 1 study testing IPI-145 in people with Hepatic Impairment, run by SecuraBio at 1 site in United States.
Trial summary
To evaluate the pharmacokinetics, safety, and tolerability of IPI-145 when administered to subjects with chronic hepatic impairment and in matched healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- IPI-145
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Oct 2014
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women of nonchildbearing potential between 18-70 years of age
- Body Mass Index (BMI): 18.0 - 38.0 kg/m2.
- Healthy subjects: in good health, determined by no clinically significant findings from clinical evaluations
- Hepatic impairment subjects: confirmed hepatic impairment >1 year with etiology of chronic alcoholism, chronic viral hepatitis (B or C), nonalcoholic steatohepatitis, autoimmune hepatitis, Wilson disease, alpha-1 antitrypsin deficiency, glycogen storage diseases, or galactosemia
- Provided written informed consent prior to any study specific procedures
Who cannot join
- Women of childbearing potential
- Hepatic impairment subjects: fluctuating or rapidly deteriorating hepatic function, acute hepatitis, variceal bleeding within 8 weeks of screening, a history of pancreatitis within 8 weeks of screening, evidence of hepatic encephalopathy > Grade 1, current unstable hematologic condition, and/or creatinine clearance < 60 mL/min
- Healthy subjects: positive screening test for hepatitis B surface antigen, or hepatitis C antibody
- ECG at screening or Day -1 showing QTcF ≥ 450 msec for healthy subjects or > 500 msec for hepatically impaired subjects
- Evidence of clinically significant medical conditions
- History of gastrointestinal disease or 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Duvelisib in Subjects With Chronic Hepatic Impairment Compared to Healthy Subjects
To evaluate the pharmacokinetics, safety, and tolerability of IPI-145 when administered to subjects with chronic hepatic impairment and in matched healthy subjects.
Read the detailed description
This is a nonrandomized, open-label, parallel-group, single oral dose study in subjects with chronic hepatic impairment and matched (age, sex, weight, BMI) healthy subjects. Subjects will be enrolled into 1 of 3 groups based on hepatic impairment grade: mild, moderate and normal hepatic function. An optional severe hepatic impairment group will enroll based on data from the mild and moderate hepatic impairment groups in comparison to matched healthy group. All subjects will receive a single oral dose of IPI-145 25 mg.
- Conditions
- Hepatic Impairment
- Being tested
- IPI-145
- Keywords
- Phase 1, hepatic impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPI-145Drug
25 mg single oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Mild Hepatic Impairment | Experimental | Not described Receives: Drug: IPI-145 |
| Moderate Hepatic Impairment | Experimental | Not described Receives: Drug: IPI-145 |
| Healthy Subjects | Experimental | Not described Receives: Drug: IPI-145 |
| Severe Hepatic Impairment | Experimental | Optional arm based on results from Arms 1, 2, and 3 Receives: Drug: IPI-145 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters of IPI-145 and its primary metabolite, IPI-656
PK parameters (AUC, Cmax and t1/2) of IPI-145 and its metabolite, IPI-656 Plasma concentrations of IPI-145 and its metabolite, IPI-656
Measured: Open 72 hours
Secondary outcomes (1)
Incidence of adverse events following administration of IPI-145
Safety Findings
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT02095587
- Sponsor's protocol ID
- IPI-145-14
- Acronym
- IPI-145-14
- Status last verified
- Mar 2021
- First submitted
- 21 Mar 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, Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Duvelisib in Subjects With Chronic Hepatic Impairment Compared to Healthy Subjects
- ClinicalTrials.gov ID
- NCT02095587
- Acronym / sponsor ID
- IPI-145-14 / IPI-145-14
- Conditions
- Hepatic Impairment
- Keywords
- Phase 1, hepatic impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- SecuraBioIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 26 Mar 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 pharmacokinetics, safety, and tolerability of IPI-145 when administered to subjects with chronic hepatic impairment and in matched healthy subjects.
Detailed description
This is a nonrandomized, open-label, parallel-group, single oral dose study in subjects with chronic hepatic impairment and matched (age, sex, weight, BMI) healthy subjects. Subjects will be enrolled into 1 of 3 groups based on hepatic impairment grade: mild, moderate and normal hepatic function. An optional severe hepatic impairment group will enroll based on data from the mild and moderate hepatic impairment groups in comparison to matched healthy group. All subjects will receive a single oral dose of IPI-145 25 mg.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild Hepatic Impairment | Experimental | Drug: IPI-145 |
| Moderate Hepatic Impairment | Experimental | Drug: IPI-145 |
| Healthy Subjects | Experimental | Drug: IPI-145 |
| Severe Hepatic Impairment | Experimental | Drug: IPI-145Optional arm based on results from Arms 1, 2, and 3 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women of nonchildbearing potential between 18-70 years of age
- Body Mass Index (BMI): 18.0 - 38.0 kg/m2.
- Healthy subjects: in good health, determined by no clinically significant findings from clinical evaluations
- Hepatic impairment subjects: confirmed hepatic impairment >1 year with etiology of chronic alcoholism, chronic viral hepatitis (B or C), nonalcoholic steatohepatitis, autoimmune hepatitis, Wilson disease, alpha-1 antitrypsin deficiency, glycogen storage diseases, or galactosemia
- Provided written informed consent prior to any study specific procedures
Key exclusion criteria (8 listed)
- Women of childbearing potential
- Hepatic impairment subjects: fluctuating or rapidly deteriorating hepatic function, acute hepatitis, variceal bleeding within 8 weeks of screening, a history of pancreatitis within 8 weeks of screening, evidence of hepatic encephalopathy > Grade 1, current unstable hematologic condition, and/or creatinine clearance < 60 mL/min
- Healthy subjects: positive screening test for hepatitis B surface antigen, or hepatitis C antibody
- ECG at screening or Day -1 showing QTcF ≥ 450 msec for healthy subjects or > 500 msec for hepatically impaired subjects
- Evidence of clinically significant medical conditions
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 single oral capsule | Drug | Healthy Subjects, Mild Hepatic Impairment, Moderate Hepatic Impairment, Severe Hepatic Impairment |
Primary outcome
Pharmacokinetic parameters of IPI-145 and its primary metabolite, IPI-656
Time frame: Open 72 hours
PK parameters (AUC, Cmax and t1/2) of IPI-145 and its metabolite, IPI-656 Plasma concentrations of IPI-145 and its metabolite, IPI-656
1 secondary outcome
Incidence of adverse events following administration of IPI-145
Time frame: 10 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 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 Hepatic Impairment, 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 5 inclusion and 8 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 of IPI-145 and its primary metabolite, IPI-656 (time frame: Open 72 hours). 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.