Status:
COMPLETED
A Study in Healthy Volunteers to Evaluate the Application of Stable Isotope Approach to Reduce Number of Subjects Needed for PK Studies
Lead Sponsor:
GlaxoSmithKline
Conditions:
Metabolic, Cardiovascular
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This will be a randomized, open-label, single dose, 4-period, period balanced, crossover study. There will be at least 5 days between dosing in each session. The study consists of Screening period (30...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG monitoring.
- Male or female between 18 and 55 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 Female subjects of child bearing potential must agree to use contraception from screening until the follow-up visit.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods.
- Body weight \>= 50 kilogram (kg) and BMI within the range 18.5 to 29.9 kilogram per meter square (kg/m\^2) (inclusive).
- Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin \<=1.5x upper limit of normal (ULN) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
- Average QT corrected using Bazett's formula (QTcB) or QT corrected using Fridericia's formula (QTcF) \<450 milliseconds (msec).
- Suitable for cannulation and with adequate venous access. Exclusion criteria
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Resting heart rate of \<50 beats per minute (bpm) at screening
- Any of the following abnormalities on 12-lead electrocardiogram (ECG) during screening: conduction abnormalities denoted by any of the following- PR interval \<120 msec or \>200 msec; non-specific IVCD (intra-ventricular conduction delay) with QRS duration \>=110 msec and where the morphology does NOT meet criteria for left (LBBB) or right bundle branch block (RBBB); incomplete RBBB as defined by QRS duration \>=100 msec but \<120 msec with RBBB pattern; complete RBBB and LBBB; evidence of second- or third- degree atrio ventricular (AV) block; pathological Q-waves (Q-wave wider than 0.04 sec or depth not greater than 0.4-0.5 millivolt \[mV\]); evidence of ventricular pre-excitation; evidence of left axis deviation (left axis deviation is -30 to -90 degrees) but not normal leftward axis, ST-T wave abnormalities.
- Documented history of low blood pressure (average systolic blood pressure \[SBP\] \<= 110 millimeters of mercury \[mm Hg\] and/or DBP \<=60 mm Hg) or semi-supine blood pressure below these values at time of screening.
- Orthostatic hypotension diagnosed at screening (orthostatic hypotension will be defined as a reduction in systolic blood pressure of 20 mm Hg or more and/or a reduction in diastolic blood pressure of 10 mmHg or more within three minutes of standing upright from supine at 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 defined as: an average weekly intake of \>21 units for males or \>14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\~240 milliliters \[mL\]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
- 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: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Unable to adhere with restrictions detailed in the informed consent or protocol.
- 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 mL within a 56 day period.
- Pregnant females as determined by positive serum or urine human chorionic gonadotropin (hCG) test at screening or prior to dosing.
- Subject is a smoker, based on at least 12 months non-smoking history.
- Lactating females.
- Subjects who have asthma or a history of asthma or of bronchospasm. Subjects with a history of childhood asthma but are now asymptomatic may be included at the investigators discretion.
Exclusion
Key Trial Info
Start Date :
January 15 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2013
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01793870
Start Date
January 15 2013
End Date
June 17 2013
Last Update
June 12 2017
Active Locations (1)
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1
GSK Investigational Site
Cambridge, United Kingdom, CB2 2GG