Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT01969266
Brief Summary:
The purpose of this study is to examine the exposure and safety of a supratherapeutic dose of PCI-32765 (ibrutinib) in healthy adult volunteers.
Detailed Description:
This is an open-label (identity of assigned study drug will be known), 2-period, sequential, exploratory study in healthy adult men and women to determine the exposure and safety of a supratherapeutic dose of PCI-32765 (ibrutinib) as a capsule or solution formulation administered with food. Eight participants (including at least 2 women) will be enrolled and receive 2 treatments: PCI-32765 840 mg will be administered as capsule (Treatment A in Period 1) and solution (Treatment B in Period 2) formulations. All participants will receive both treatments with a 7-day washout period between doses. A high-fat breakfast will be provided 2 hours before dosing. Serial pharmacokinetic (study of what the body does to a drug) samples will be collected before dosing and over 72 hours after each dose and safety will be monitored throughout the study. The total duration of the study will be approximately 46 days.
Study:
NCT01969266
Study Brief:
Protocol Section:
NCT01969266