Effect of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Participants

Venous Thromboembolism Clinical Trial

Official title:

Effect of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02912234
• Other study ID #: CV185-547
• Status: Completed
• Phase: Phase 1
• First received: September 19, 2016
• Last updated: November 18, 2016
• Start date: September 2016
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the effects of multiple-dose clarithromycin on the single-dose pharmacokinetics (PK) of apixaban with parameters like Cmax, AUC(INF), and AUC(0-T).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Signed Informed Consent

2. Target population: Healthy subjects as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests including coagulation parameters.

3. Subjects with body mass index of 18 to 30 kg/m2, inclusive

4. Women must not be breast feeding, have a negative serum or urine pregnancy test and must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatments apixaban and clarithromycin plus 5 half-lives of study treatments apixaban and clarithromycin plus 30 days (duration of ovulatory cycle) for a total of 33 days post-treatment completion.

5. Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatments apixaban and clarithromycin plus 5 half-lives of the study treatment plus 30 days for a total of 33 days post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time.

Exclusion Criteria:

1. History of any significant medical illness, drug allergy including allergy to apixaban, FXa inhibitors (and/or their excipients), clarithromycin, macrolides, and/or related compounds. History of substance abuse and use of nicotine containing products and/or alcohol abuse.

2. History of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation, including hypermenorrhea, intra-cranial hemorrhage, family history of bleeding disorders in first degree relatives, and/or any adverse reaction to anticoagulants or antiplatelet agents that resulted in excessive bleeding.

3. History of recurrent neurological or gastrointestinal disorders, including insomnia, chronic headaches, dizziness, gastroesophageal reflux disease, cholecystectomy, gastric ulcers and/or Gilbert's syndrome.

4. History of antibiotic induced secondary infections, including candidiasis.

5. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory tests beyond what is consistent with the target population.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Apixaban
Multiple-dose clarithromycin and single-dose Apixaban
• Clarithromycin
Multiple-dose clarithromycin and single-dose Apixaban

Locations

Country	Name	City	State
United States	Ppd Development, Llc	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed concentration (Cmax)		Days 1-11	No
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))		Days 1-11	No
Primary	Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))		Days 1-11	No
Secondary	Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death		Screening- until 30 days after discontinuation of dosing or subject's participation in the study if the last	Yes

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