- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01424540
Cross-Over Study to Assess the Cardiovascular Effects of GSK2336805
A Randomized, Double Blind, Single Dose, Cross-Over Study to Assess the Cardiovascular Effects of GSK2336805 in Healthy Adult Volunteers
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
New York
-
Buffalo, New York, Förenta staterna, 14202
- GSK Investigational Site
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin less than or equal to 1.5xUpper Limit of Normal (ULN).
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including [medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included at the discretion of the Investigator only if the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, oophorectomy, or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea.
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.
- Body weight greater than or equal to 50 kilogram (kg) for men and 45 kg for women. Body mass index (BMI) between 18.5-30 inclusive will be allowed.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Subject has demonstrated an adequate echocardiographic window.
- QTcB less than 450 milliseconds (msec).
Exclusion Criteria:
- A positive pre-study Hepatitis B surface antigen,positive Hepatitis C antibody, or a positive test for HIV antibody result within 3 months of screening.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- History of regular alcohol consumption within 6 months of the study.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mililiters within a 56 day period.
- Pregnant females as determined by positive [serum or urine] hCG test at screening or prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Subjects who have asthma or a history of asthma.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice [and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices] from 7 days prior to the first dose of study medication.
- Left ventricular ejection fraction less than 55% at screening.
- The subject's systolic blood pressure is outside the range of 90-140, or diastolic blood pressure is outside the range of 45-90 or heart rate is outside the range of 50-100beats per minute for female subjects or 45-100 beats per minute for male subjects.
- Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination):
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).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Treatment A
GSK2336805 150mg
|
Single Dose
|
Placebo-jämförare: Treatment B
GSK2336805 Placebo
|
Single Dose
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of subjects with a change in ejection fraction greater than 10 percent
Tidsram: 10 hours
|
Echocardiographic measures of contractility
|
10 hours
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of subjects with electrocardiogram (ECG) parameters out of range
Tidsram: 3 hours
|
Cardiovascular measures
|
3 hours
|
Number of subjects with vital signs out of range
Tidsram: 24 hours
|
Cardiovascular measures
|
24 hours
|
Number of subjects with adverse events
Tidsram: 24 hours
|
tolerability
|
24 hours
|
Number of subjects using concurrent medication
Tidsram: 24 hours
|
Concomitant medications
|
24 hours
|
Number of subjects with laboratory values out of range
Tidsram: 24 hours
|
Labs
|
24 hours
|
Area under the curve (0-24)
Tidsram: 24 hours
|
PK parameter
|
24 hours
|
Maximum observed concentration (Cmax)
Tidsram: 24 hours
|
PK parameter
|
24 hours
|
Terminal phase half-life
Tidsram: 24 hours
|
PK parameter
|
24 hours
|
Lag time before observation of drug concentrations in sampled matrix
Tidsram: 24 hours
|
PK parameter
|
24 hours
|
Time of occurrence of Cmax
Tidsram: 24 hours
|
PK parameter
|
24 hours
|
Concentration at 24 hours
Tidsram: 24 hours
|
PK parameter
|
24 hours
|
Correlation between concentration and various safety parameters
Tidsram: 24 hours
|
Safety, PK
|
24 hours
|
B-type natriuretic peptide (BNP) lab result
Tidsram: 24 hours
|
Cardiac biomarkers
|
24 hours
|
Troponin lab results
Tidsram: 24 hours
|
Cardiac biomarkers
|
24 hours
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 115535
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