Phase 1
Completed N=21
Phase 1 Oral Solution Bioavailability Study of Apixaban When Administered Through a Nasogastric Tube in Healthy Subjects
Healthy Volunteers
Source: ClinicalTrials.gov NCT02034578 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcomePrimary: Adjusted Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Apixaban — 190.873; 181.862; 153.693 ng/mL
Summary
The purpose of this study is to assess the bioavailability of Apixaban solution administered through NGT and washed with Dextrose 5% in water (D5W) or infant formula relative to Apixaban solution administered orally in healthy subjects
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Apixaban |
190.873; 181.862; 153.693 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Death |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Median Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban |
0.517; 1.000; 1.00 | — |
| SECONDARY Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration, AUC(0-T), of Apixaban |
1269.784; 1226.339; 1166.572 | — |
| SECONDARY Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time, AUC(INF), of Apixaban |
1292.775; 1250.913; 1192.387 | — |
| SECONDARY Mean Plasma Elimination Half-Life (T-HALF) of Apixaban |
10.5; 10.4; 10.6 | — |
| SECONDARY Number of Participants With Clinically Significant Electrocardiogram, Vital Sign, or Physical Examination Findings |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Marked Abnormality in Hematology, Chemistry and Urinalysis Laboratory Tests |
1; 1; 5; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
Exclusion Criteria
- Any significant acute or chronic medical illness
- Any history or evidence of abnormal bleeding or coagulation disorders, intracranial hemorrhage, or abnormal bleeding (including heavy menstrual bleeding that has resulted in anemia within the past 1 year) or coagulation disorders in a first degree relative
Data sourced from ClinicalTrials.gov (NCT02034578). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.