Status:
COMPLETED
Phase I Study of Pyrimethamine in Healthy Japanese and Caucasian Subjects
Lead Sponsor:
GlaxoSmithKline
Conditions:
Toxoplasmosis
Eligibility:
MALE
20-64 years
Phase:
PHASE1
Brief Summary
Pyrimethamine in combination with a sulphonamide is known to be effective in the treatment of toxoplasmosis. However, Pyrimethamine has not been approved by the Japanese regulatory body (Pharmaceutica...
Eligibility Criteria
Inclusion
- Subjects should be between 20 and 64 years of age inclusive, at the time of signing the informed consent.
- Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Body weight \>= 50 kilograms (kg) and body mass index (BMI) within the range 18.5 to 30.0 kilogram per square meters (kg/m\^2) (inclusive).
- Japanese or Caucasian male.
- A male subject must agree to use contraception during the treatment period and until follow-up.
- Japanese ethnic origin defined as having been born in Japan, having four ethnic Japanese grandparents, holding a Japanese passport or identity papers and being able to speak Japanese. Subjects should also have lived outside Japan for less than 10 years at the time of screening.
- Caucasian subject will be defined as an individual having four grandparents who are all descendants of the original people of Europe.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions of the study.
Exclusion
- Alanine aminotransferase (ALT) \> 1.5 times upper limit of normal (ULN).
- Bilirubin \> 1.5 times ULN (isolated bilirubin \> 1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35 percent).
- QT interval corrected for heart rate according to Fridericia's formula (QTcF) \> 450 milliseconds (msec).
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- History of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
- Abnormal blood pressure as determined by the investigator.
- Hematological values: outside normal range at screening.
- Serum creatinine level: outside normal range at screening visit.
- Past or intended use of over-the-counter or prescription medication including herbal medications within 14 days prior to dosing.
- Participation in the study would result in loss of blood or blood products in excess of 500 milliliters (mL) within 3 months.
- Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
- Current enrollment or past participation within the last 30 days before signing of consent in this clinical study involving an investigational study treatment or any other type of medical research.
- Presence of Hepatitis B surface antigen (HBsAg) at screening or positive Hepatitis C antibody test result at screening. Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained.
- Positive Hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment. Test is optional and subjects with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing.
- Positive pre-study drug/alcohol screen.
- Positive human immunodeficiency virus (HIV) antibody test.
- Regular use of known drugs of abuse.
- Regular alcohol consumption within 6 months prior to the study defined as: For an average weekly intake of \> 14 units for males. One unit is equivalent to 10 grams (g) of alcohol: a can of mid-strength (equivalent to 375 mL) beer, 1 glass (100 mL) of table wine or 1 measure (30 mL) of spirits (including rice wine).
- History or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Sensitivity to any of the study treatments, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
Key Trial Info
Start Date :
September 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2017
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03258762
Start Date
September 25 2017
End Date
November 19 2017
Last Update
March 27 2020
Active Locations (1)
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1
GSK Investigational Site
Melbourne, Victoria, Australia, 3004