Assessment of Safety and Pharmacokinetics of a Low Dose of Methotrexate in Healthy Adult Male Kenyan Volunteers

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: Male

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 of this drug in healthy adult male Kenyan volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: KEMRI-Wellcome Trust Collaborative Research Program
• Collaborator: University of Oxford
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• Males, Aged > 18 -< 55years old; weighing 55-75 kg

• Serum haemoglobin >10g/dl

• HIV negative status

• Written informed consent from the study subject.

Exclusion Criteria:

• 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.