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Duvelisib in Hepatically Impaired Subjects Compared to Healthy Subjects (IPI-145-14)

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ClinicalTrials.gov Identifier: NCT02095587
Recruitment Status : Completed
First Posted : March 26, 2014
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Verastem, Inc.

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.

Condition or disease Intervention/treatment Phase
Hepatic Impairment Drug: IPI-145 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : March 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Experimental: Mild Hepatic Impairment Drug: IPI-145
25 mg single oral capsule

Experimental: Moderate Hepatic Impairment Drug: IPI-145
25 mg single oral capsule

Experimental: Healthy Subjects Drug: IPI-145
25 mg single oral capsule

Experimental: Severe Hepatic Impairment
Optional arm based on results from Arms 1, 2, and 3
Drug: IPI-145
25 mg single oral capsule




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of adverse events following administration of IPI-145 [ Time Frame: 10 days ]
    Safety Findings



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095587


Locations
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United States, Florida
Miami, Florida, United States, 33014
Sponsors and Collaborators
Verastem, Inc.
Investigators
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Principal Investigator: Dr. Kenneth Lasseter Clinical Pharmacology of Miami
Study Chair: Hagop Youssoufian, MD Verastem, Inc.

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Responsible Party: Verastem, Inc.
ClinicalTrials.gov Identifier: NCT02095587     History of Changes
Other Study ID Numbers: IPI-145-14
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: July 2017
Keywords provided by Verastem, Inc.:
Phase 1
hepatic impairment
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases