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

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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02095574

Enrollment

Registered

2014-03-26

Start date

2014-09-30

Completion date

2015-01-31

Last updated

2014-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/Refractory Non-Hodgkin's Lymphoma

Keywords

GDC-0199, ADME, Relapsed, Refractory, ABT-199, Non-Hodgkin's Lymphoma

Brief summary

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

Interventions

DRUG[14C]ABT-199 (GDC-0199)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Subject must have relapsed or refractory disease. 2. 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

. 3. Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2. 4. Subject has adequate bone marrow (independent of growth factor support per local laboratory reference range). 5. Subject has adequate coagulation, renal and hepatic function.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026