GSK Investigational Site
Buffalo, New York, 14202, United States
NCT Number: NCT01424540
This is a single-center, randomized, two part, double-blind, crossover study in healthy adult subjects to assess the effect of a single dose of GSK2336805 150mg on cardiac function comparing with placebo using echocardiography as a primary assessment modality
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Buffalo, New York, 14202, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until the follow up visit.
Exclusion criteria
Males-Heart rate less than 45 and greater than 100 beats per minute (bpm). Females-Heart rate less than 50 and greater than 100 bpm Evidence of previous myocardial infarction (Does not include ST segment changes associated with repolarization).
Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block [2nd degree or higher], Wolf Parkinson White [WPW] syndrome). Sinus Pauses greater than 3 seconds. Any significant arrhythmia which, in the opinion of the principal investigator and GSK medical monitor, will interfere with the safety for the individual subject. Non-sustained or sustained ventricular tachycardia ( greater than or equal to 3 consecutive ventricular ectopic beats).
Single Dose
Single Dose
Time frame: 10 hours
Echocardiographic measures of contractility
Time frame: 3 hours
Cardiovascular measures
Time frame: 24 hours
Cardiovascular measures
Time frame: 24 hours
tolerability
Time frame: 24 hours
Concomitant medications
Time frame: 24 hours
Labs
Time frame: 24 hours
PK parameter
Time frame: 24 hours
PK parameter
Time frame: 24 hours
PK parameter
Time frame: 24 hours
PK parameter
Time frame: 24 hours
PK parameter
Time frame: 24 hours
PK parameter
Time frame: 24 hours
Safety, PK
Time frame: 24 hours
Cardiac biomarkers
Time frame: 24 hours
Cardiac biomarkers
GlaxoSmithKline
Industry
A Randomized, Double Blind, Single Dose, Cross-Over Study to Assess the Cardiovascular Effects of GSK2336805 in Healthy Adult Volunteers
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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