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:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT01932320
Brief Summary:
The purpose of this study is to compare the rate and extent of absorption of a single dose of two solid dose formulations relative to a nanosuspension formulation of JNJ-40411813 (Part 1); to evaluate the effect of a high-fat/high-calorie breakfast on the rate and extent of absorption of the selected JNJ-40411813 solid dose formulation from Part 1 (Part 2); and to explore the influence of a potent inhibitor of CYP3A4, ketoconazole, on the rate and extent of absorption of the selected JNJ-40411813 solid dose formulation from Part 1 (Part 3).
Detailed Description:
This is an open-label (both physician and participants know the identity of the intervention) and single centre study. This study will be conducted in 3 parts (Part 1, Part 2, and Part 3). The study consists of 3 phases including, the screening phase (within 21 days prior to the start of study medication), treatment phase (Part 1: 20 days; Part 2: 12 days; Part 3: 16 days), and the follow-up phase (Part 1 and Part 2: approximately 14 days after the last administration of study medication and Part 3: 14 days after the last administration of ketaconazole). Approximately 36 participants will be enrolled in the study (12 participants in each part). Part 1 is randomized (study medication is assigned by chance) and 3-way cross-over (method used to switch participants from one treatment arm to another in a clinical study) part of the study. Participants in Part 1 will be randomly assigned to 1 of 3 treatment sequences (Period 1, Period 2, and Period 3) to receive single dose of 3 formulations of JNJ-40411813 (Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation) without food. Each period will be separated by a wash out period (no treatment) of at least 1 week. Part 2 is randomized and 2-way cross-over part of the study. Participants in Part 2 will be randomly assigned 1 of 2 treatment sequences (Period 1 and Period 2) to receive single dose of the selected solid dose formulation of JNJ-40411813 from Part 1 without food and with food separated by a wash out period of at least 1 week. Part 3 is single-arm sequential (carried out in a staged approach) part of the study. Participants in Part 3 will receive single dose of the selected solid dose formulation of JNJ-40411813 from Part 1 on two occasions (Day 1 and Day 10) without food along with ketoconazole from Day 6 to Day 14 with food. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, 12-lead electrocardiogram, and clinical laboratory tests which will be monitored throughout the study. The total duration of study participation for a participant will be 8 weeks.
Study:
NCT01932320
Study Brief:
Protocol Section:
NCT01932320