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Safety and Dose Ranging Study for OWL-EVO1 as a Lung Cancer EVOC® Probe (Evolution)

NCT05510674 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2023-12-20

No results posted yet for this study

Summary

The Evolution study is a phase 1a and 1b study evaluating the safety and pharmacokinetics of D5- ethyl-βGlucuronide as well as the target dose for the probe to maximize the difference between controls and subjects with lung cancer.

The phase 1a study will be designed as a single ascending dose study in healthy volunteers and will be conducted in a phase 1 trial unit with a primary objective to assess safety of the probe. A subsequent phase 1b study will be conducted at clinical sites and will aim to find the optimal dosing and breath sampling protocol to maximize the accuracy of the breath test.

Evolution Phase 1 is a multicentre study; Phase 1a will be conducted at a Phase 1 facility in Belgium and Phase 1b will be conducted in the UK.

Conditions

Interventions

DIAGNOSTIC_TEST

OWL-EVO1

EVOC probe

Sponsors & Collaborators

  • Owlstone Ltd

    lead INDUSTRY

Principal Investigators

  • Robert Rintoul · Royal Papworth Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-06
Primary Completion
2023-09-20
Completion
2023-09-20

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05510674 on ClinicalTrials.gov