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

NCT00791531 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2012-04-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Methotrexate

Oral methotrexate 5mg once daily for 5 consecutive days

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • KEMRI-Wellcome Trust Collaborative Research Program

    lead OTHER

Principal Investigators

  • Alexis Nzila, Msc · KEMRI-Wellcome Trust Collaborative Research Program

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00791531 on ClinicalTrials.gov