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Characterisation of the Human Carboxylesterase 1 (CES1) Mutations in Thailand

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01443806
Recruitment Status : Completed
First Posted : September 30, 2011
Last Update Posted : June 27, 2018
South East Asia Infectious Disease Clinical Research Network
Information provided by (Responsible Party):
University of Oxford

Brief Summary:
The aim of this study is to evaluate the conversion of OP to OC in individual X and the family member of individual X. The investigators hypothesize that one or more of the single nucleoprotein polymorphisms (SNPs) of the CES1 gene represent a clinically important functional polymorphism.

Condition or disease Intervention/treatment Phase
Metabolic Disease Drug: Oseltamivir Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Characterisation of the Human Carboxylesterase 1 (CES1) Mutation(s) Which May be Responsible for Markedly Reduced Conversion of Oseltamivir Phosphate to Oseltamivir Carboxylate
Study Start Date : July 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Oseltamivir, genetic testing Drug: Oseltamivir
75 mg, one time
Other Name: Tamiflu

Primary Outcome Measures :
  1. Tmax [ Time Frame: 2 and 4 hours ]
    Conversion of Oseltamivir at 2 and 4 hours post dose

Secondary Outcome Measures :
  1. Conversion of oseltamivir phosphate to oseltamivir carboxylate [ Time Frame: one year (anticipate) ]
    Document the sequence of all 14 exons of CES1 from individual X and the family members of individual X.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Signed informed consent
  • Healthy family member of individual X and individual X
  • Aged between 18 and 70, inclusive.

Exclusion Criteria:

  • known allergy to oseltamivir
  • any underlying illness that is considered a risk to the health of the individual
  • pregnant
  • breast feeding
  • creatinine clearance < 30 mL/min calculated by the Cockcroft Gault formula: CrCl (ml/min) = (140-age) x Wt in kg / creatinine mg/dL x 72, for females, the result is multiplied by 0.85.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01443806

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The Faculty of Tropical medicine,Mahidol University
Bangkok, Thailand, 10400
Sponsors and Collaborators
University of Oxford
South East Asia Infectious Disease Clinical Research Network
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Principal Investigator: Sasithon Pukrittayakamee, MD. Mahidol University
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Responsible Party: University of Oxford Identifier: NCT01443806    
Other Study ID Numbers: SEA 026
First Posted: September 30, 2011    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Keywords provided by University of Oxford:
oseltamivir metabolism
Carboxylesterase 1
Additional relevant MeSH terms:
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Metabolic Diseases
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action