A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK1278863A in Healthy Subjects

Completed · Phase 1

Conditions studied: Anaemia

In brief

A first-time in human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1278863A in healthy subjects

Key facts

Study ID: NCT00750256
Run by: GlaxoSmithKline
People needed: 36
Starts: 2008-07-07
Expected to finish: 2008-12-12
Last updated by the study team: 2017-07-21

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Healthy, non-smoking (within 40 days of screening), adult males and females between 18 and 55 years of age, inclusive
Female subjects are eligible for participation in the study if they are of:
Non-childbearing potential (i.e., physiologically incapable of becoming pregnant);
Male subjects agree to use contraception methods
Body weight > or = 50 kg; BMI: 19-31 kg/m2, inclusive
Subject has a QTc <450 msec or <480 msec if associated with bundle branch block
Subject is willing and able to provide written informed consent

You may not qualify if…

MCV value outside the reference range at screening
Hemoglobin value at screening is: male subjects or post-menopausal females > 15.5 g/dL; female subjects > 14.5 g/dL
TIBC, serum iron and serum ferritin values are outside the reference range at screening
Calculated creatinine clearance < 60 ml/min
Clinically significant abnormal CPK determined by the investigator and medical monitor
AST, ALT and direct bilirubin are greater than upper limit of reference range at screening
Subjects are unwilling or inability to follow the procedures and lifestyle and/or dietary restrictions outlined in the protocol
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, unless in the opinion of the Investigator and GSK Medical Monitor this will not interfere with the study procedures or compromise subject safety
Subject currently exposures to more than four new chemical entities within 12 months prior to the first dosing day
Use of other prescription or non-prescription drugs, vitamins, herbal and dietary supplements, within 7 days prior to the first dose of study medication
Subject has a history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy
Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs.
Subject has a history of GI ulceration or gastrointestinal bleeding
Subject has a history of peptic ulcer disease
Subject has a history of malignancy tumor; non-melanoma skin cancer that has been definitely removed is allowed
Treatment with an investigational drug within 30 days preceding the first dose of study medication
Subjects with a history of drug abuse
History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening
Positive urine drug screen (UDS) at screening
Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result or positive HIV result within 3 months of screening
Donation of blood in excess of 500 mL within 56 days prior to first dose of study medication
Subject has a history of regular use of tobacco- or nicotine containing products
History of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity to any of the study medications or components thereof

Where it is running

GSK Investigational Site — Evansville, Indiana, United States

Full record on ClinicalTrials.gov

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