Local Institution
Nottingham, Nottinghamshire, NG11 6JS, United Kingdom
NCT Number: NCT02112110
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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Notify Me18 year–49 year
All sexes
Interventional
Phase 1
Nottingham, Nottinghamshire, NG11 6JS, United Kingdom
Primary Purpose: Other: Protocol is designed to assess the absolute bioavailability of 150 mg (2x75 mg tablets) BMS-791325 administered orally
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
Exclusion criteria
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)
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.
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)
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
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
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
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
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
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
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
Bristol-Myers Squibb
Industry
Study of the Absolute Oral Bioavailability of BMS-791325 in Healthy Subjects
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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