Bioavailability of Apixaban Sprinkle Compared to Apixaban Capsules

NCT03509883 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CV185-687
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the absorption of apixaban (BMS-562247) into the bloodstream of healthy volunteers, when administered as sprinkle capsules compared to tablets. Eligible participants will be randomly assigned to 1 of 2 treatment sequences and will receive a single oral dose of apixaban twice during the course of the study.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Concentration as Measured by Maximum Observed Plasma Concentration (Cmax)

  Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of concentration

  Day 1 to Day 8

• AUC (0-T) - Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration

  Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time

  Day 1 to Day 8

• AUC (INF) - Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time

  Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time

  Day 1 to Day 8

Secondary Outcomes (13)

• Tmax - Time of Maximum Observed Plasma Concentration

  Day 1 to Day 8

• T-Half - Terminal Plasma Half Life.

  Day 1 to Day 8

• Frel - Relative Bioavailability

  Day 1 to Day 8

• Number of Participants With Adverse Events Regardless of Causality, Serious Adverse Events and Adverse Events Leading to Discontinuation

  Day 1 to Day 38

• Physical Measurement - Height

  Pre-treatment Screening

Study Arms (2)

Apixaban sprinkle capsules followed by apixaban tablets

EXPERIMENTAL

Apixaban (BMS-562247) sprinkle capsules followed by apixaban tablets

Drug: Drug: Apixaban sprinkle capsules; Drug: Experimental: Apixaban tablets followed by apixaban sprinkle capsules

Apixaban tablets followed by apixaban sprinkle capsules

ACTIVE COMPARATOR

Apixaban (BMS-562247) tablets followed by apixaban sprinkle capsules

Drug: Drug: Apixaban sprinkle capsules; Drug: Experimental: Apixaban tablets followed by apixaban sprinkle capsules

Interventions

Drug: Apixaban sprinkle capsules DRUG

Single dose (25 x 0.1 mg capsules), oral administration

Also known as: •BMS-562247, •Eliquis

Apixaban sprinkle capsules followed by apixaban tablets; Apixaban tablets followed by apixaban sprinkle capsules

Experimental: Apixaban tablets followed by apixaban sprinkle capsules DRUG

Apixaban sprinkle capsules Single dose (25 x 0.1 mg capsules), oral administration

Also known as: •BMS-562247

Apixaban sprinkle capsules followed by apixaban tablets; Apixaban tablets followed by apixaban sprinkle capsules

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent form.
• Healthy male and female participants determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs (electrocardiograms), vital signs and clinical laboratory determinations.
• Women of childbearing potential (WOCBP) must have negative serum pregnancy tests (performed at screening and Day 1), must not be breastfeeding, and must agree to follow instructions for method(s) of contraception for duration of treatment with study drug apixaban, and for a total of 33 days after last dose of apixaban.
• Males sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for duration of treatment with study drug apixaban, and for a total of 93 days after the last dose of apixaban; and must be willing to refrain from sperm donation during this time.
• Body mass index (BMI) of 18.0 to 30.0 kg/m², inclusive. Body mass index = weight (kg)/\[height(m)\]².

You may not qualify if:

• History of chronic headaches (occurring 15 days or more a month) over the previous 3 months.
• History of gastroesophageal reflux disease, dyspepsia, protracted nausea, or chronic diarrhea.
• History or evidence of abnormal bleeding or coagulation disorders, hypermenorrhea, intracranial hemorrhage, or abnormal bleeding or coagulation disorders.
• Inability to comply with restrictions and prohibited treatments (e.g. women currently taking hormonal contraception).
• Use of tobacco- or nicotine-containing products (e.g. cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, nicotine gum) within 6 months prior to study drug administration.
• Donation of blood to a blood bank or in a clinical study (except screening or follow-up visit) within 4 weeks of study drug administration (within 2 weeks for plasma only).

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

PPD Development, LP

Austin, Texas, 78744, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

apixaban

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: April 26, 2018
• Study Start: April 26, 2018
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: January 23, 2020
• Results First Posted: January 23, 2020

Record last verified: 2020-01

Locations

US (1)