Phase 1 Assessment of Safety and Pharmacokinetics of a Low Dose of Methotrexate in Healthy Adult Male Kenyan Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Clinical safety parameters:oral ulcers, GI tract disturbance,hematology, renal hepatic & other unsolicited safety AEs
Study Overview
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 of this drug in healthy adult male Kenyan volunteers.
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 need to develop new and cheap drugs. The investigators have discovered that the old drug methotrexate (MTX), which is used in the treatment of cancer and rheumatoid arthritis (RA), is very active against malaria parasites, including those that are resistant to existing antimalarials.
In the treatment of RA, MTX is used weekly at a low dose for several years. At dose, MTX is safe and well tolerated in human and children. This low dose of MTX will also kill malaria parasite in human. Thus, want to study MTX as an antimalarial. As part of this study, the investigators need to establish whether at the dose the investigators want it, 5 mg per days for 5 days, the drug is safe and well tolerated in 25 Kenyan adult volunteers. This result of this study will inform us on the use of MTX in the treatment of malaria in children.
What questions are the investigators trying to answer?
The investigators are trying to assess the safety of 5mg dose per day for 5
Where is the study taking place, how many people does it involve and how are they selected?
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Methotrexate
Oral methotrexate 5mg once daily for 5 consecutive days
Intervention: Methotrexate (Drug)
Outcomes
Primary Outcomes
Clinical safety parameters:oral ulcers, GI tract disturbance,hematology, renal hepatic & other unsolicited safety AEs
Time Frame: 42 days
Secondary Outcomes
- Pharmacokinetics of Methotrexate assessed by repeated measurement of blood concentrations(42 days)