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

NCT00791531 | Completed Phase 1

• 1 other identifier: SSC1464
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

Methotrexate; Malaria

Outcome Measures

Primary Outcomes (1)

• Clinical safety parameters:oral ulcers, GI tract disturbance,hematology, renal hepatic & other unsolicited safety AEs

  42 days

Secondary Outcomes (1)

• Pharmacokinetics of Methotrexate assessed by repeated measurement of blood concentrations

  42 days

Study Arms (1)

Methotrexate

EXPERIMENTAL

Oral methotrexate 5mg once daily for 5 consecutive days

Drug: Methotrexate

Interventions

Methotrexate DRUG

Oral methotrexate 5mg once daily for 5 consecutive days

Also known as: Methotrexate Lerdele

Methotrexate

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males, Aged \> 18 -\< 55years old; weighing 55-75 kg
• Serum haemoglobin \>10g/dl
• HIV negative status
• Written informed consent from the study subject.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KEMRI-Wellcome Trust Collaborative Research Program: lead
• University of Oxford: collaborator

Study Sites (1)

Kenya Medical Research Institute, Center for Clinical Research

Nairobi, Nairobi County, 00200, Kenya

Location

Related Publications (1)

• Chilengi R, Juma R, Abdallah AM, Bashraheil M, Lodenyo H, Nyakundi P, Anabwani E, Salim A, Mwambingu G, Wenwa E, Jemutai J, Kipkeu C, Oyoo GO, Muchohi SN, Kokwaro G, Niehues T, Lang T, Nzila A. A phase I trial to evaluate the safety and pharmacokinetics of low-dose methotrexate as an anti-malarial drug in Kenyan adult healthy volunteers. Malar J. 2011 Mar 16;10:63. doi: 10.1186/1475-2875-10-63.

  PMID: 21410944 RESULT

MeSH Terms

Conditions

Malaria

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Alexis Nzila, Msc

  KEMRI-Wellcome Trust Collaborative Research Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 14, 2008
• Study Start: March 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 24, 2012

Record last verified: 2012-04

Locations

KE (1)