A Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics of BMS-986177 in Healthy Subjects

Thrombosis Clinical Trial

Official title:

An Open-Label, Single-Sequence Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics of BMS-986177 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02959060
• Other study ID #: CV010-014
• Status: Completed
• Phase: Phase 1
• First received: November 7, 2016
• Last updated: January 5, 2017
• Start date: November 2016
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• 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 effect of rifampin on the single-dose pharmacokinetics (PK) of BMS-986177 in healthy participants with parameters like Cmax, AUC(INF), AUC(0-T)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Signed Informed Consent

2. Healthy men and women (not of child bearing potential) 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 and with normal kidney function.

4. Women participants must have documented proof that they are not of childbearing potential.

5. Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986177 plus 5 half-lives (3 days) plus 90 days (duration of sperm turnover) for a total of 93 days after completion of BMS-986177 treatment.

Exclusion Criteria:

1. Any significant acute or chronic medical illness, including any other condition listed as a contraindication in the rifampin package insert

2. History of recurrent headaches, dizziness, chronic diarrhea, gastroesophageal reflux disease, dyspepsia, gastrointestinal ulcer disease, recurrent urinary tract infections, hypermenorrhea and recurrent candida infections, abnormal bleeding, history of hemophilia, Rosenthal syndrome, FXIa deficiency, or other coagulopathies.

3. Recent surgery, head injury, blood transfusion, systemic lupus erythamatous, aneurysm, drug or alcohol abuse and use of tobacco or nicotine containing products in past six months.

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

5. History of allergy to BMS-986177, FXIa inhibitors , rifampin or related compounds

Study Design

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

Related Conditions & MeSH terms

• Thrombosis

Intervention

Drug:
• BMS-986177
Single dose of BMS-986177 and multiple doses of Rifampin
• Rifampin
Single dose of BMS-986177 and multiple doses of Rifampin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax)		Days1-15	No
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))		Days1-15	No
Primary	Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))		Days1-15	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	Yes

External Links

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