Validation of Drug Assays in Various Biological Matrices | NCT02283112

Studies
Validation of Drug Assays in Various Biological Matrices

NCT02283112

Sponsor

University of Liverpool

Status

Recruiting

Last Update Posted

May 11, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Infection

Interventions

antivirals, antimicrobials, oral contraceptive, erectile dysfunction agents

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Oct 29, 2014

First Submission Date that Met QC Criteria

Nov 4, 2014

First Posted Date

Nov 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2026

Last Update Posted Date

May 11, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Name	Type	Description	Arm Group Labels	Other Names
antivirals, antimicrobials, oral contraceptive, erectile dysfunction agents	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 18 years of age

Exclusion Criteria:

Unable to give informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Helen Reynolds	Contact			TherEx-trials@liverpool.ac.uk

Overall Officials

Name	Affiliation	Role
Saye Khoo	University of Liverpool	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Liverpool University Hospital	Recruiting	Liverpool		L7 8XP	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000998	Antiviral Agents
D000890	Anti-Infective Agents
D003276	Contraceptives, Oral

Ancestor Terms

ID	Term
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D003271	Contraceptive Agents, Female

Browse Leaves

Not provided

Browse Branches

Not provided