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Completed

NCT Number: NCT02112110

Absolute Bioavailability of BMS-791325

The purpose of this study is to determine the absolute bioavailability of 150 mg oral dose of BMS-791325 relative to 100 µg IV infusion of [13C]-BMS-791325.

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Key information

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

About this study

Primary Purpose: Other: Protocol is designed to assess the absolute bioavailability of 150 mg (2x75 mg tablets) BMS-791325 administered orally

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

  • Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
  • Men and women ages 18 to 49 years, inclusive
  • Women of childbearing potential (WOCBP) must not be pregnant or breastfeeding
  • WOCBP and men who are sexually active with WOCBP must agree to follow protocol mandated instructions for method(s) of contraception during and after the study

Exclusion criteria

  • Any significant acute or chronic medical illness
  • Any current or recent gastrointestinal disease or surgery that could impact upon the absorption of study drug
  • Inability to tolerate oral medication
  • Inability to be venipunctured and/or tolerate venous access
  • Use of tobacco-containing or nicotine-containing products within 6 months
  • Recent (within 6 months of study drug administration) drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (4th Edition)(DSM IV), Diagnostic Criteria for Drug and Alcohol Abuse
  • Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration at screening or Day -1, confirmed by repeat

i)PR ≥ 210 msec

ii)QRS ≥ 120 msec

iii)QT ≥ 500 msec

iv)QTcF ≥ 450 msec

v)Second or third degree heart block

h) Positive urine screen for drugs of abuse

i) Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, r HIV-1, -2 antibodies

j) Any of the following screening or Day -1 laboratory results outside the ranges specified below as defined by the laboratory, confirmed by repeat analysis:

i)Serum creatinine > upper limit of normal (ULN)

ii)Alanine aminotransferase (ALT) > ULN

iii)Aspartate aminotransferase(AST) > ULN

iv)Total bilirubin > ULN

k) History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)

Treatment and study plan

BMS-791325

Drug

[13C]-BMS-791325

Drug

Primary outcomes

  1. Absolute oral bioavailability (F) of BMS-791325

    Time frame: 48 hours from time of oral dosing

    Absolute bioavailability of 150 mg (2x75 mg tablets) BMS-791325 administered orally will be established by calculating the ratio of the dose normalized AUC(INF) of oral dose with that of 100 µg IV infused dose.

Secondary outcomes

  1. Safety and tolerability of BMS-791325 by the occurrence of AEs and SAEs, abnormalities in vital sign measurements exceeding pre-defined thresholds, findings on ECGs and PEs, and abnormalities and marked abnormalities in clinical laboratory test.

    Time frame: Day 1 predose and 2 hours post-dose, Day 2 and Day 3

    Serious adverse events (SAEs)

    Adverse events (AEs)

    Physical examinations (PEs)

  2. Maximum observed plasma concentration (Cmax) of BMS-791325 (oral dose) and [13C]-BMS-791325 (IV dose)

    Time frame: Pre-dose and at 0.5, 1, 1.5, 1.75, 1.97, 2, 2.125, 2.25, 2.5, 2.75, 3, 4, 5, 6, 8, 10, 12, 16, 24, 28, 32, 36 and 48 hours post oral dose

  3. Time of maximum observed plasma concentration (Tmax) of BMS-791325 (oral dose) and [13C]-BMS-791325 (IV dose)

    Time frame: Pre-dose and at 0.5, 1, 1.5, 1.75, 1.97, 2, 2.125, 2.25, 2.5, 2.75, 3, 4, 5, 6, 8, 10, 12, 16, 24, 28, 32, 36 and 48 hours post oral dose

  4. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-791325 (oral dose) and [13C]-BMS-791325 (IV dose)

    Time frame: Pre-dose and at 0.5, 1, 1.5, 1.75, 1.97, 2, 2.125, 2.25, 2.5, 2.75, 3, 4, 5, 6, 8, 10, 12, 16, 24, 28, 32, 36 and 48 hours post oral dose

  5. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-791325 (oral dose) and [13C]-BMS-791325 (IV dose)

    Time frame: Pre-dose and at 0.5, 1, 1.5, 1.75, 1.97, 2, 2.125, 2.25, 2.5, 2.75, 3, 4, 5, 6, 8, 10, 12, 16, 24, 28, 32, 36 and 48 hours post oral dose

  6. Terminal plasma half-life (T-HALF) of BMS-791325 (oral dose) and [13C]-BMS-791325 (IV dose)

    Time frame: Pre-dose and at 0.5, 1, 1.5, 1.75, 1.97, 2, 2.125, 2.25, 2.5, 2.75, 3, 4, 5, 6, 8, 10, 12, 16, 24, 28, 32, 36 and 48 hours post oral dose

  7. Total clearance (CLT) of [13C]-BMS-791325 (IV dose)

    Time frame: Pre-dose and at 0.5, 1, 1.5, 1.75, 1.97, 2, 2.125, 2.25, 2.5, 2.75, 3, 4, 5, 6, 8, 10, 12, 16, 24, 28, 32, 36 and 48 hours post oral dose

  8. Volume of distribution at steady-state (Vss) of [13C]-BMS-791325 (IV dose)

    Time frame: Pre-dose and at 0.5, 1, 1.5, 1.75, 1.97, 2, 2.125, 2.25, 2.5, 2.75, 3, 4, 5, 6, 8, 10, 12, 16, 24, 28, 32, 36 and 48 hours post oral dose

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Study of the Absolute Oral Bioavailability of BMS-791325 in Healthy Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 11, 2014
Registry last updated
Jun 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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