Single-Blind, Placebo-Controlled, Randomized Study Testing Single Ascending Doses Of GSK369796 In Healthy Subjects
This study has been completed.
Medicines for Malaria Venture
Information provided by (Responsible Party):
First received: April 22, 2008
Last updated: March 15, 2012
Last verified: October 2011
This study will examine safety of single doses of GSK369796 in healthy subjects, along with some test to examine how quickly GSK369796 gets in your blood, and how long it takes your body to get rid of it.
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
||Single-blind, Placebo-controlled, Randomized Study Testing Single Ascending Doses of GSK369796 in Healthy Subjects
Primary Outcome Measures:
- Safety and tolerability [ Time Frame: From Day 1 to follow-up visit ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2008 (Final data collection date for primary outcome measure)
Experimental: Anti-malarial experimental drug
Other Name: GSK369796
|Ages Eligible for Study:
||18 Years to 40 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Any clinically relevant abnormality identified on the screening history and physical exam, screening 12-lead surface electrocardiogram (ECG), and screening 24-holter cardiac monitoring.
- Any evidence of cardiac disease or other clinically relevant abnormality identified on the screening echocardiography.
- Any clinically relevant abnormality on the clinical safety laboratory tests at screening.
- Positive for Human Immunodeficiency Virus (HIV) antibody, hepatitis B virus surface antigen, or hepatitis C virus antibody at screening.
- Significant cardiac history including but not limited to history of myocardial infarction, angina, heart failure, cardiomyopathy, arrhythmia, myocarditis, hypertrophy (atrial or ventricular), or cor pulmonale.
- Significant central nervous system (e.g., seizures), pulmonary, metabolic, renal, hepatic or gastrointestinal conditions or history of such conditions that, in the opinion of the investigator and/or GSK medical monitor, places the subject at an unacceptable risk as a participant in this trial or may interfere with the absorption, distribution, metabolism or excretion of drugs.
- History of sensitivity to any of the study medications or components thereof.
- History of sensitivity to 4-aminoquinolines (e.g., chloroquine, amodiaquine, or piperaquine).
- History of sensitivity to heparin or heparin-induced thrombocytopenia, if the clinical research unit will use heparin to maintain intravenous cannula patency.
- Use of prescription or non-prescription drugs, vitamins, herbal and dietary supplements within 14 days or 5 half-lives (whichever is longer) prior to study medication administration, or use of St. John's Wort within 28 days prior to the study medication administration Unless in the opinion of the investigator and sponsor the medication will not interfere with study procedures or compromise safety. By exception, the volunteer may take paracetamol (</ 2 grams/day) up to 48 hours prior to the study medication administration.
- Consumption of grapefruit, grapefruit juice, orange juice or Seville oranges, red wine within 7 days prior to administration of study medication.
- Participation in a clinical study of an investigational or non-investigational drug within 3 months or 5 half-lives (whichever is longer) preceding the study medication administration.
- Exposure to more than four new chemical entities within 12 months prior to dosing.
- History of drug abuse within 6 months of the study.
- A positive urine test for drugs of abuse or alcohol (or alcohol breath test) at screening or predose.
- History of smoking or use of nicotine containing products within 3 months of screening, or a positive urine cotinine indicative of smoking at screening.
- History of regular alcohol consumption exceeding 14 units/week or 2 units/day for women, or 21 units/week or 3 units/day for men, within 6 months of screening. One unit is equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine.
- An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women, or an unwillingness of male subjects to use a condom/spermicide, in addition to having their female partner use another form of contraception such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation, if engaging in sexual intercourse with a female partner who could become pregnant. This criterion must be followed from the time of study medication administration and until 84 days later.
- Donation of blood in excess of 500 mL within 90 days prior to dosing.
- An unwillingness to comply with lifestyle and/or dietary restrictions
Please refer to this study by its ClinicalTrials.gov identifier: NCT00675064
|GSK Investigational Site
|London, United Kingdom, NW10 7NS |
Medicines for Malaria Venture
||GSK Clinical Trials
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 22, 2008
||March 15, 2012
||United Kingdom: Medicines and Healthcare Products Regulatory Agency
Keywords provided by GlaxoSmithKline:
single ascending dose,
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014