Pharmacokinetic Study of BKM120 in Subjects With Hepatic Impairment
NCT01727128 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2020-12-09
Summary
To assess pharamcokinetics, safety and tolerability of a single oral dose of BKM120 in subjects with mild, moderate and severe hepatic impairment
Conditions
- Hepatic Impairment
Interventions
- DRUG
-
BKM120
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-10-31
- Primary Completion
- 2013-08-31
- Completion
- 2013-08-31
Countries
- Bulgaria
- Germany
- Russia
Study Locations
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