Phase 1 Oral Solution Bioavailability Study of Apixaban When Administered Through a Nasogastric Tube in Healthy Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Apixaban

Study type: Interventional

Funder types: Industry

Identifiers

NCT02034578

CV185-091

Details and patient eligibility

About

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

Enrollment: 75 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

75 participants in 3 patient groups

Arm A: Apixaban

Experimental group

Description:

Single dose Apixaban 5 mg (0.4 mg/mL x 12.5 mL) oral solution via oral syringe

Treatment:

Drug: Apixaban

Arm B: Apixaban

Experimental group

Description:

Single dose Apixaban 5 mg (0.4 mg/mL x 12.5 mL) oral solution via nasogastric tube (NGT) immediately followed by 60 mL of D5W via NGT

Treatment:

Drug: Apixaban

Arm C: Apixaban

Experimental group

Description:

Single dose Apixaban 5 mg (0.4 mg/mL x 12.5 mL) oral solution via NGT immediately followed by 60 mL of infant formula via NGT

Treatment:

Drug: Apixaban