Status:
COMPLETED
Assessment of Safety and Pharmacokinetics of a Low Dose of Methotrexate in Healthy Adult Male Kenyan Volunteers
Lead Sponsor:
KEMRI-Wellcome Trust Collaborative Research Program
Collaborating Sponsors:
University of Oxford
Conditions:
Malaria
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
Previous investigations indicate that methotrexate, an old anticancer drug, could be used at low doses to treat malaria. This is a phase I evaluation to assess the safety and pharmacokinetic profile o...
Detailed Description
Background Currently the control of malaria rests on the use of chemotherapy. However, the development of resistance to common used drugs represents a major public concern. Thus, the investigators nee...
Eligibility Criteria
Inclusion
- Males, Aged \> 18 -\< 55years old; weighing 55-75 kg
- Serum haemoglobin \>10g/dl
- HIV negative status
- Written informed consent from the study subject.
Exclusion
- Severe underlying conditions such as malnutrition (W/H \<70%), clinically suspected cardiac, renal, or hepatic diseases, suspected AIDS, or severe injury.
- Presence of any concomitant illnesses such malaria, lower respiratory tract infections (LRTI), acute bloody or non-bloody diarrhoeas, or other as acute infections
- History of treatment with antimalarial drugs within the last 2 weeks
- History of treatment with aspirin or any non-steroidal-anti-inflammatory agent or trimethoprim and co-trimoxazole within the last 7 days.
- Any ongoing medication.
- Abnormal clinical chemistry or haematological finding
- Alcohol/drugs intake
- Any other reason in the recruiting clinician's opinion that makes the individual unsuitable for taking part in a clinical trial.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00791531
Start Date
March 1 2009
End Date
August 1 2009
Last Update
April 24 2012
Active Locations (1)
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1
Kenya Medical Research Institute, Center for Clinical Research
Nairobi, Nairobi County, Kenya, 00200