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A Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Pharmacokinetics of BMS-986177 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02807909
Recruitment Status : Completed
First Posted : June 21, 2016
Last Update Posted : September 12, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The study is being conducted to assess the effects of co-administration of itraconazole or diltiazem, respectively, on the pharmacokinetic (PK) parameters Cmax, AUC(INF), and AUC(0-T) of BMS-986177

Condition or disease Intervention/treatment Phase
Thrombosis Drug: BMS-986177 Drug: Itraconazole Drug: Diltiazem ER Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-Label Single-Sequence Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Single-Dose Pharmacokinetics of BMS-986177 in Healthy Subjects
Study Start Date : July 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arm Intervention/treatment
Experimental: BMS-986177 and Itraconazole
Single dose BMS-986177 on day 1 followed by Itraconazole and BMS-986177 on specified days
Drug: BMS-986177
Drug: Itraconazole
Experimental: BMS-986177 and Diltiazem
Single dose BMS-986177 on day 1 followed by Diltiazem ER and BMS-986177 on specified days
Drug: BMS-986177
Drug: Diltiazem ER



Primary Outcome Measures :
  1. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC (0-T)) of BMS-986177 [ Time Frame: Days 1-12 ]
  2. Maximum observed concentration (Cmax) [ Time Frame: Days 1-12 ]
  3. Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) [ Time Frame: Days 1-12 ]

Secondary Outcome Measures :
  1. Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death [ Time Frame: Screening- until 30 days after discontinuation of dosing or subject's participation in the study if the last scheduled visit occurs at a later time. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 determinations.
  3. Subjects with body mass index of 18 to 30 kg/m2, inclusive
  4. Men, and women of nonchildbearing potential. Women must have documented proof that they are not of childbearing potential and are not breast feeding
  5. Males who are sexually active with women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of the study drug (3 days) plus 90 days (duration of sperm turnover) for a total of 92 days for subjects in the BMS-986177 - diltiazem sequence, and 99 days for subjects in the BMS-986177 - itraconazole sequence.

Exclusion Criteria:

  1. Any significant acute or chronic medical illness, including hepatic disease, or any other condition listed as a contraindication in the diltiazem or itraconazole package inserts.
  2. Evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation.
  3. History of chronic constipation, GI disease, arrhythmias, sinus bradycardia, significant head injury, dizziness or headaches, hemophilia, Rosenthal syndrome, or FX1a deficiency or other coagulopathies, systemic lupus erythematosus.
  4. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
  5. History of allergy to BMS-986177, itraconazole, diltiazem, or related compounds.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807909


Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02807909     History of Changes
Other Study ID Numbers: CV010-005
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: September 12, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Diltiazem
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents