A Phase 1 interventional study of Rivaroxaban in Pharmacokinetics, Bioavailability and Healthy Participants, sponsored by Janssen Scientific Affairs, LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-24.
Sponsored by Janssen Scientific Affairs, LLC · Phase 1, Interventional, and Treatment
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.
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:
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.
Janssen Scientific Affairs, LLC is the lead sponsor of 40 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive a single 20 mg-dose of rivaroxaban as a whole tablet swallowed intact with 70 mL of applesauce and 130 mL of water followed by a liquid meal (100 mL of Osmolite® 1.5 Cal at 0, 0.5, 1, 1.5 and 2 hours after receiving the study drug) in Period 1 (Treatment A,) followed by a single 20 mg-dose of rivaroxaban crushed and mixed in 70 ml of applesauce, followed by 2 mortar rinses of 65 mL each of water (to ensure delivery of the entire dose) and a liquid meal (100 mL of Osmolite® 1.5 Cal at 0, 0.5, 1, 1.5 and 2 hours after receiving the study drug) in Period 2 (Treatment B) and followed by 20 mL of water via NG tube (to prime and pre-wet the lumen), followed by a single 20 mg-dose of rivaroxaban crushed and suspended in 50 mL of water given via NG tube, followed by 2 mortar rinses of 65 mL each of water and a liquid meal (100 mL of Osmolite® 1.5 Cal at 0, 0.5, 1, 1.5 and 2 hours after receiving the study drug) in Period 3 (Treatment C.)
Drug: Rivaroxaban
Participants will receive a single 20 mg-dose of rivaroxaban as a whole tablet swallowed intact with 70 mL of applesauce and 130 mL of water followed by a liquid meal (100 mL of Osmolite® 1.5 Cal at 0, 0.5, 1, 1.5 and 2 hours after receiving the study drug) in Period 1 (Treatment A,) followed by 20 mL of water via NG tube (to prime and pre-wet the lumen), followed by a single 20 mg-dose of rivaroxaban crushed and suspended in 50 mL of water given via NG tube, followed by 2 mortar rinses of 65 mL each of water and a liquid meal (100 mL of Osmolite® 1.5 Cal at 0, 0.5, 1, 1.5 and 2 hours after receiving the study drug) in Period 2 (Treatment C) and followed by a single 20 mg-dose of rivaroxaban crushed and mixed in 70 ml of applesauce, followed by 2 mortar rinses of 65 mL each of water (to ensure delivery of the entire dose) and a liquid meal (100 mL of Osmolite® 1.5 Cal at 0, 0.5, 1, 1.5 and 2 hours after receiving the study drug) in Period 3 (Treatment B.)
Drug: Rivaroxaban
Participants will receive a single 20 mg-dose of rivaroxaban crushed and mixed in 70 ml of applesauce, followed by 2 mortar rinses of 65 mL each of water (to ensure delivery of the entire dose) and a liquid meal (100 mL of Osmolite® 1.5 Cal at 0, 0.5, 1, 1.5 and 2 hours after receiving the study drug) in Period 1 (Treatment B,) followed by a single 20 mg-dose of rivaroxaban crushed and suspended in 50 mL of water given via NG tube, followed by 2 mortar rinses of 65 mL each of water and a liquid meal (100 mL of Osmolite® 1.5 Cal at 0, 0.5, 1, 1.5 and 2 hours after receiving the study drug) in Period 2 (Treatment C) and followed by a single 20 mg-dose of rivaroxaban as a whole tablet swallowed intact with 70 mL of applesauce and 130 mL of water followed by a liquid meal (100 mL of Osmolite® 1.5 Cal at 0, 0.5, 1, 1.5 and 2 hours after receiving the study drug) in Period 3 (Treatment A.)
Drug: Rivaroxaban
Participants will receive a single 20 mg-dose of rivaroxaban crushed and mixed in 70 ml of applesauce, followed by 2 mortar rinses of 65 mL each of water (to ensure delivery of the entire dose) and a liquid meal (100 mL of Osmolite® 1.5 Cal at 0, 0.5, 1, 1.5 and 2 hours after receiving the study drug) in Period 1 (Treatment B,) followed by a single 20 mg-dose of rivaroxaban as a whole tablet swallowed intact with 70 mL of applesauce and 130 mL of water followed by a liquid meal (100 mL of Osmolite® 1.5 Cal at 0, 0.5, 1, 1.5 and 2 hours after receiving the study drug) in Period 2 (Treatment A) and followed by 20 mL of water via NG tube (to prime and pre-wet the lumen), followed by a single 20 mg-dose of rivaroxaban crushed and suspended in 50 mL of water given via NG tube, followed by 2 mortar rinses of 65 mL each of water and a liquid meal (100 mL of Osmolite® 1.5 Cal at 0, 0.5, 1, 1.5 and 2 hours after receiving the study drug) in Period 3 (Treatment C.)
Drug: Rivaroxaban
Participants will receive a single 20 mg-dose of rivaroxaban crushed and suspended in 50 mL of water given via NG tube, followed by 2 mortar rinses of 65 mL each of water and a liquid meal (100 mL of Osmolite® 1.5 Cal at 0, 0.5, 1, 1.5 and 2 hours after receiving the study drug) in Period 1 (Treatment C,) followed by a single 20 mg-dose of rivaroxaban as a whole tablet swallowed intact with 70 mL of applesauce and 130 mL of water followed by a liquid meal (100 mL of Osmolite® 1.5 Cal at 0, 0.5, 1, 1.5 and 2 hours after receiving the study drug) in Period 2 (Treatment A) and followed by and followed by a single 20 mg-dose of rivaroxaban crushed and mixed in 70 ml of applesauce, followed by 2 mortar rinses of 65 mL each of water (to ensure delivery of the entire dose) and a liquid meal (100 mL of Osmolite® 1.5 Cal at 0, 0.5, 1, 1.5 and 2 hours after receiving the study drug) in Period 3 (Treatment B.)
Drug: Rivaroxaban
Participants will receive a single 20 mg-dose of rivaroxaban crushed and suspended in 50 mL of water given via NG tube, followed by 2 mortar rinses of 65 mL each of water and a liquid meal (100 mL of Osmolite® 1.5 Cal at 0, 0.5, 1, 1.5 and 2 hours after receiving the study drug) in Period 1 (Treatment C,) followed by and followed by a single 20 mg-dose of rivaroxaban crushed and mixed in 70 ml of applesauce, followed by 2 mortar rinses of 65 mL each of water (to ensure delivery of the entire dose) and a liquid meal (100 mL of Osmolite® 1.5 Cal at 0, 0.5, 1, 1.5 and 2 hours after receiving the study drug) in Period 2 (Treatment B) and followed by a single 20 mg-dose of rivaroxaban as a whole tablet swallowed intact with 70 mL of applesauce and 130 mL of water followed by a liquid meal (100 mL of Osmolite® 1.5 Cal at 0, 0.5, 1, 1.5 and 2 hours after receiving the study drug) in Period 3 (Treatment A.)
Drug: Rivaroxaban
Single 20 mg-dose
Rivaroxaban plasma concentrations
Time frame: Approximately 30 days
The number of patients with adverse events reported
Time frame: Up to approximately 60 days
Change from baseline in coagulation tests (prothrombin time [PT] and partial thromboplastin time [PTT])
Time frame: Baseline and at approximately 47 days
Change from baseline in Electrocardiograms (ECGs)
Time frame: Baseline and at approximately 47 days
Number of participants with abnormal vital signs
Time frame: Baseline and at approximately 10 days, 20 days and 30 days
Number of participants with changes in physical examinations
Time frame: Baseline and at approximately 10 days, 20 days and 30 days
Urine Drug Screen
Time frame: Baseline and at approximately 10 days and 20 days
Change from baseline in clinical lab assessments (chemistry, hemotology)
Time frame: Baseline and at approximately 30 days
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Janssen Scientific Affairs, LLC