Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-29 @ 11:04 AM
Study NCT ID:
NCT01464450
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2011-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics Study of Oral Rivaroxaban in Healthy Participants
Sponsor:
Janssen Scientific Affairs, LLC
Organization:
Study Overview
Official Title:
PK Study of Oral Rivaroxaban in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to learn about the relative bioavailability (the extent to which the drug becomes available to the body) and pharmacokinetics (blood levels) of rivaroxaban in healthy participants after receiving a 20 mg rivaroxaban tablet orally as a whole tablet, crushed and mixed in applesauce, and as a suspension through a Naso-gastric (NG) tube. The relative bioavailability of rivaroxaban may be different when given as a crushed tablet compared with an intact (whole) tablet and when given via an NG tube. The safety and tolerability of rivaroxaban will also be assessed.
Detailed Description:
This is a single-center, open-label (all people know the identity of the drug), randomized (the study drug is assigned by chance), 3-period, 3-treatment cross over study of the relative bioavailability (the extent to which the drug becomes available to the body) of single dose rivaroxaban given to healthy participants in 3 ways. All participants will be randomly assigned to follow 1 of 6 possible ordered sequences whereby they ultimately receive rivaroxaban as: a whole tablet orally (Treatment A), a crushed tablet mixed in applesauce orally (Treatment B), and a crushed tablet in a water suspension administered via NG tube (Treatment C). Each rivaroxaban treatment will be taken with food (a standardized liquid meal).
Participants will be randomly assigned into one of the following 6 sequences:
* Sequence 1: Treatment A - Treatment B - Treatment C
* Sequence 2: Treatment A - Treatment C - Treatment B
* Sequence 3: Treatment B - Treatment C - Treatment A
* Sequence 4: Treatment B - Treatment A - Treatment C
* Sequence 5: Treatment C - Treatment A - Treatment B
* Sequence 6: Treatment C - Treatment B - Treatment A.
It is expected that a total of 9 participants will be randomly assigned into each sequence. Each single-dose treatment period will be followed by a washout period (period when receiving no treatment) of sufficient length to ensure absence of drug carry over from one treatment period to the next.
The study will enroll approximately 54 participants to achieve 42 completed participants.
The study will consist of a screening phase (no longer than 21 days before entering the clinical research facility on the day before starting the study drug), randomly assigned to 1 of 6 sequences, and an open-label treatment phase consisting of 3 treatment periods (4 days for each treatment) separated by a washout period of 6-14 days between rivaroxaban administrations in each treatment periods.
Participants will be admitted to the study unit in the morning of the day before the giving of the first dose of study drug (Day -1). Study drug will be given in the morning of the first day of each treatment period (Day 1), followed by a standard Osmolite® 1.5 Cal (Abbott Laboratories) liquid meal.
Participants will receive study drug in the morning and Osmolite® 1.5 Cal will be given as the breakfast meal. Osmolite® 1.5 Cal is a standardized source of balanced nutrition for patients requiring low-residue meals via a feeding tube or orally and/or who may have limited volume tolerance or fluid restrictions. An Osmolite® 1.5 Cal meal includes 1.5 calories/mL overall, and 62.7 g of protein/L. Participants can have a regular meal 3 or more hours after the Osmolite® 1.5 Cal meal.
Each treatment period will be followed by a 6 to 14 day washout period. The washout period will start after the giving of study drug.
Participants will be randomly assigned into one of the following 6 sequences:
* Sequence 1: Treatment A - Treatment B - Treatment C
* Sequence 2: Treatment A - Treatment C - Treatment B
* Sequence 3: Treatment B - Treatment C - Treatment A
* Sequence 4: Treatment B - Treatment A - Treatment C
* Sequence 5: Treatment C - Treatment A - Treatment B
* Sequence 6: Treatment C - Treatment B - Treatment A.
It is expected that a total of 9 participants will be randomly assigned into each sequence. Each single-dose treatment period will be followed by a washout period (period when receiving no treatment) of sufficient length to ensure absence of drug carry over from one treatment period to the next.
The study will enroll approximately 54 participants to achieve 42 completed participants.
The study will consist of a screening phase (no longer than 21 days before entering the clinical research facility on the day before starting the study drug), randomly assigned to 1 of 6 sequences, and an open-label treatment phase consisting of 3 treatment periods (4 days for each treatment) separated by a washout period of 6-14 days between rivaroxaban administrations in each treatment periods.
Participants will be admitted to the study unit in the morning of the day before the giving of the first dose of study drug (Day -1). Study drug will be given in the morning of the first day of each treatment period (Day 1), followed by a standard Osmolite® 1.5 Cal (Abbott Laboratories) liquid meal.
Participants will receive study drug in the morning and Osmolite® 1.5 Cal will be given as the breakfast meal. Osmolite® 1.5 Cal is a standardized source of balanced nutrition for patients requiring low-residue meals via a feeding tube or orally and/or who may have limited volume tolerance or fluid restrictions. An Osmolite® 1.5 Cal meal includes 1.5 calories/mL overall, and 62.7 g of protein/L. Participants can have a regular meal 3 or more hours after the Osmolite® 1.5 Cal meal.
Each treatment period will be followed by a 6 to 14 day washout period. The washout period will start after the giving of study drug.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| RIVAROXNAP1001 | OTHER | Janssen Scientific Affairs, LLC | View |