NCT01443806

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 30, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

1.4 years

First QC Date

July 12, 2011

Last Update Submit

June 25, 2018

Conditions

Metabolic Disease

Keywords

oseltamivir metabolismCarboxylesterase 1

Outcome Measures

Primary Outcomes (1)

  • Tmax

    Conversion of Oseltamivir at 2 and 4 hours post dose

    2 and 4 hours

Secondary Outcomes (1)

  • Conversion of oseltamivir phosphate to oseltamivir carboxylate

    one year (anticipate)

Study Arms (1)

Oseltamivir, genetic testing

EXPERIMENTAL
Drug: Oseltamivir

Interventions

OseltamivirDRUG

75 mg, one time

Also known as: Tamiflu
Oseltamivir, genetic testing

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Faculty of Tropical medicine,Mahidol University

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Metabolic Diseases

Interventions

Oseltamivir

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Study Officials

  • Sasithon Pukrittayakamee, MD.

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2011

First Posted

September 30, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 27, 2018

Record last verified: 2018-06

Locations

TH(1)