Effect of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Participants

NCT02912234 | Completed Phase 1

• 1 other identifier: CV185-547
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (3)

• Maximum observed concentration (Cmax)

  Days 1-11

• Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

  Days 1-11

• Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))

  Days 1-11

Secondary Outcomes (1)

• 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

Study Arms (1)

Apixaban and Clarithromycin

EXPERIMENTAL

Drug: Apixaban; Drug: Clarithromycin

Interventions

Apixaban DRUG

Multiple-dose clarithromycin and single-dose Apixaban

Apixaban and Clarithromycin

Clarithromycin DRUG

Multiple-dose clarithromycin and single-dose Apixaban

Apixaban and Clarithromycin

Eligibility Criteria

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

You may qualify if:

• Signed Informed Consent
• Target population: Healthy subjects as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests including coagulation parameters.
• Subjects with body mass index of 18 to 30 kg/m2, inclusive
• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• History of recurrent neurological or gastrointestinal disorders, including insomnia, chronic headaches, dizziness, gastroesophageal reflux disease, cholecystectomy, gastric ulcers and/or Gilbert's syndrome.
• History of antibiotic induced secondary infections, including candidiasis.
• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Ppd Development, Llc

Austin, Texas, 78744, United States

Location

Related Publications (1)

• Garonzik S, Byon W, Myers E, Li X, Marchisin D, Murthy B. The Effects of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Volunteers: A Single-Sequence Crossover Study. Am J Cardiovasc Drugs. 2019 Dec;19(6):561-567. doi: 10.1007/s40256-019-00348-2.

  PMID: 31030414 DERIVED

Related Links

• BMS Clinical Trial Education Resource
• FDA Safety Alerts and Recalls
• Investigator Inquiry Form

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

apixaban; Clarithromycin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 23, 2016
• Study Start: September 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 21, 2016

Record last verified: 2016-11

Locations

US (1)