Validation of Drug Assays in Various Biological Matrices

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02283112

Enrollment

100

Registered

2014-11-05

Start date

2014-10-01

Completion date

2027-12-31

Last updated

2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Brief 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.

Interventions

OTHERantivirals, antimicrobials, oral contraceptive, erectile dysfunction agents

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* \> 18 years of age

Exclusion criteria

* Unable to give informed consent

Design outcomes

Primary

Measure	Time frame	Description
To measure drug concentrations using high performance liquid chromatography -tandem mass spectrometry (HPLC-MS/MS) (accuracy and precision of assays that measure drug concentrations)	Follow up up to 5 years	Assay validation

Countries

United Kingdom

Contacts

CONTACTHelen Reynolds

TherEx-trials@liverpool.ac.uk

PRINCIPAL_INVESTIGATORSaye Khoo

University of Liverpool

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 12, 2026