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Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects

NCT03340597 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2018-08-02

No results posted yet for this study

Summary

A Phase I, open label study evaluating safety, tolerability and pharmacokinetics of F901318 in healthy subjects following up to 28 days dosing, where F901318 is given orally . The effect of food upon the pharmacokinetics of F901318 and the effect of F901318 upon the pharmacokinetics of midazolam will also be assessed.

Conditions

  • Invasive Aspergillosis

Interventions

DRUG

F901318

F901318 tablet

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • F2G Biotech GmbH

    lead INDUSTRY

Principal Investigators

  • Jim Bush, MB ChB PhD MRCS FFPM · Covance CRU Ltd

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2017-12-12
Primary Completion
2018-04-13
Completion
2018-04-13

Countries

  • United Kingdom

Study Locations

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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 NCT03340597 on ClinicalTrials.gov