NCT02283112

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress88%
Oct 2014Dec 2027

Study Start

First participant enrolled

October 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 5, 2014

Completed
13.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 11, 2026

Status Verified

February 1, 2026

Enrollment Period

13.3 years

First QC Date

October 29, 2014

Last Update Submit

May 6, 2026

Conditions

Infection

Outcome Measures

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

    Follow up up to 5 years

Interventions

antivirals, antimicrobials, oral contraceptive, erectile dysfunction agentsOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \> 18 years of age

You may not qualify if:

  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Infections

Interventions

Antiviral AgentsAnti-Infective AgentsContraceptives, Oral

Intervention Hierarchy (Ancestors)

Therapeutic UsesPharmacologic ActionsChemical Actions and UsesContraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of Drugs

Study Officials

  • Saye Khoo

    University of Liverpool

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen Reynolds

CONTACT

TherEx-trials@liverpool.ac.uk

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2014

First Posted

November 5, 2014

Study Start

October 1, 2014

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 11, 2026

Record last verified: 2026-02

Locations

GB(1)