A Pharmacokinetic Study to Access How the Body Absorbs and Removes ABT-199 in Adults With Non-Hodgkin's Lymphoma

Sponsor

AbbVie (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT02095574

Collaborator

Genentech, Inc. (Industry)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief Summary

A pharmacokinetic study to access how the body absorbs and removes ABT-199 in adults with Non-Hodgkin's Lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Relapsed/Refractory Non-Hodgkin's Lymphoma	Drug: [14C]ABT-199 (GDC-0199)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Disposition of [14C] ABT-199 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL) Following a Single Oral Dose Administration

Study Start Date :

Sep 1, 2014

Anticipated Primary Completion Date :

Sep 1, 2014

Anticipated Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: [14C]ABT-199 Subjects with relapsed or refractory Non-Hodgkin's Lymphoma	Drug: [14C]ABT-199 (GDC-0199) [14C]ABT-199 will be administered as a single oral administration

Arm

Intervention/Treatment

Experimental: [14C]ABT-199

Subjects with relapsed or refractory Non-Hodgkin's Lymphoma

Drug: [14C]ABT-199 (GDC-0199)

[14C]ABT-199 will be administered as a single oral administration

Outcome Measures

Primary Outcome Measures

Maximum observed plasma concentration (Cmax) of ABT-199 and [14C]ABT-199 [For approximately 9 days following a single oral dose of [14C]ABT-199]
Time to Cmax (Tmax) for ABT-199 and [14C]ABT-199 [For approximately 9 days following a single oral dose of [14C]ABT-199]
Area Under the Time curve (AUC) for ABT-199 and [14C]ABT-199 [For approximately 9 days following a single oral dose of [14C]ABT-199]
The area under the exposure-time curve from time zero to Day 9 and time zero extrapolated to infinite time for single dose of [14C]ABT-199

Secondary Outcome Measures

Number of subjects with adverse events [At each visit (daily for approximately the first 9 days)]
Adverse event monitoring, lab test assessment, physical exam and vital signs will be evaluated throughout the study.
Percentage of subjects with adverse events [At each visit (daily for approximately the first 9 days)]
Adverse event monitoring, lab test assessment, physical exam and vital signs will be evaluated throughout the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject must have relapsed or refractory disease.
Subject must have histologically documented diagnosis of non-hodgkin's lymphoma as defined by a B-cell neo-plasm in the World Health Organization (WHO) classification scheme except as noted in exclusion criteria.
Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
Subject has adequate bone marrow (independent of growth factor support per local laboratory reference range).
Subject has adequate coagulation, renal and hepatic function.

Exclusion Criteria:

Subject has been diagnosed with Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic lymphocytic leukemia (CLL), mantle cell leukemia (MCL), or small lymphocytic lymphoma (SLL).
Subject has undergone an allogeneic stem cell transplant.
Subject is receiving combination anti-retroviral therapy for human immunodeficiency virus (HIV) (due to potential drug-drug interactions, as well as the potential for increased risk of opportunistic infections).
Subject has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease within 6 months that in the opinion of the Investigator would adversely affect his/her participation in this study.
Subject has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.