Clinical trial NCT02095587: Duvelisib in Hepatically Impaired Subjects Compared to Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Keywords: Phase 1
hepatic impairment
Lead sponsor: SecuraBio
Sponsor class: INDUSTRY
First posted: 2014-03-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pharmacokinetic parameters of IPI-145 and its primary metabolite, IPI-656
timeFrame: Open 72 hours
Secondary outcomes:
measure: Incidence of adverse events following administration of IPI-145
timeFrame: 10 days
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
Study officials:
affiliation: Verastem, Inc.
name: Hagop Youssoufian, MD
role: STUDY_CHAIR
References: