Status:
COMPLETED
Repeat Dose Safety Study for Compound to Treat Anemia
Lead Sponsor:
GlaxoSmithKline
Conditions:
Kidney Disease
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to characterize the safety and tolerability of repeat doses of compound 1278863A in healthy subjects.
Detailed Description
Compound 1278863A is a novel small molecule agent, which stimulates erythropoiesis through inhibition of hypoxia-inducible factor (HIF)-prolyl hydroxylases (EGLNs). This compound is being developed fo...
Eligibility Criteria
Inclusion
- Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Male or female between 18 and 55 years of age, inclusive.
- A female subject must be of non-childbearing potential.
- Male subjects must agree to use one of the acceptable contraception methods listed in the protocol
- Body weight greater than or equal to 50 kg and BMI within the range 19 - 31 kg/m2 (inclusive).
- Capable of giving written informed consent
- QTcB or QTcF \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block.
Exclusion
- The subject has a positive pre-study drug screen.
- A hemoglobin value at screening is:
- Male subjects or post-menopausal females: \> 15.5 g/dL
- Female subjects: \> 14.5 g/dL
- The values of hematological parameters at screening are:
- MCV: outside the reference range and clinically significant deemed by the investigator and GSK Medical Monitor
- The values of the following tests at screening are:
- TIBC: outside the reference range
- Serum iron: outside the reference range
- Serum ferritin: outside the reference range
- A value at screening is greater than the upper limit of reference range for the following clinical laboratory parameters: AST, ALT, direct bilirubin.
- Clinically significant abnormal CPK determined by the investigator and GSK Medical Monitor.
- Calculated creatinine clearance: \< 60mL/min
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- A positive test for HIV antibody.
- History of drug abuse or dependence within 6 months of the study.
- History of regular alcohol consumption within 6 months of the study
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- 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 drug
- History of sensitivity to any of the study drugs, 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.
- History of sensitivity to heparin or heparin-induced thrombocytopenia. (if the clinical research unit uses heparin to maintain intravenous cannula patency)
- Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, and/or hepatic function that could interfere with the absorption, metabolism, and/or excretion of the study drugs.
- History of peptic ulcer disease.
- History of malignancy tumor. Non-melanoma skin cancer that has been definitely removed is allowed.
- Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
- Lactating females.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Unwillingness or inability to follow the procedures, or lifestyle and/or dietary restrictions outlined in the protocol.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice, exotic citrus fruits, grapefruit hybrids or fruit juices of the prohibited fruits from 7 days prior to the first dose of study medication
- 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).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Subject is mentally or legally incapacitated.
Key Trial Info
Start Date :
March 13 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00840320
Start Date
March 13 2009
End Date
September 2 2009
Last Update
June 22 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Melbourne, Victoria, Australia, 3004