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RecruitingNCT02283112Updated May 11, 2026

Validation of Drug Assays in Various Biological Matrices

An observational study in Infection, sponsored by University of Liverpool. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by University of Liverpool · Observational

From the registry’s dates

  • Started Oct 2014; still recruiting 12 years 1 month later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study summary

This study aims to ensure that assays that measure drug concentrations are accurate and precise in different matrices when quantified using high performance liquid chromatography -tandem mass spectrometry (HPLC-MS/MS). The study involves collecting samples of various bodily fluids to quantify antimicrobials, antivirals, oral contraceptives and erectile dysfunction agents. Samples will also be obtained from individuals not receiving these medications for quality control purposes.

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Conditions studied

  • Infection

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03

In context

Infections

2,093 studies on the registry are indexed under Infections; 364 are open to participants now.

This study's planned enrollment of 100 is below the median of 300 across 685 observational studies indexed under Infections.

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Lead sponsor

University of Liverpool is the lead sponsor of 99 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy volunteers receiving specific medication or healthy volunteers taking no medication.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • > 18 years of age

Exclusion criteria

Exclusion Criteria:

  • Unable to give
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Otherantivirals, antimicrobials, oral contraceptive, erectile dysfunction agents
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What researchers measure

Primary outcomes

  1. To measure drug concentrations using high performance liquid chromatography -tandem mass spectrometry (HPLC-MS/MS) (accuracy and precision of assays that measure drug concentrations)

    Assay validation

    Time frame: Follow up up to 5 years

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02283112
Lead sponsor
University of Liverpool
Responsible party
Sponsor
First posted
Nov 5, 2014
Start date
Oct 2014
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
May 11, 2026

Study contacts

Helen Reynolds
Contact
TherEx-trials@liverpool.ac.uk
Saye Khoo
principal investigator · University of Liverpool

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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