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Fed-Fasted, Single and Multiple Ascending Dose Trial of XEN-D0103

NCT02390258 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2015-03-18

No results posted yet for this study

Summary

This study is an evaluation of the safety and tolerability of XEN-D0103 in healthy subjects. Part 1 assesses the safety, tolerability and blood levels of the ascending single doses of XEN-D0103. Blood levels of XEN-D0103 will be assessed when administered with food and also without food in Part 2. The safety, tolerability and blood levels of XEN-D0103 will be assessed following dosing for 10 days in Part 3.

Conditions

Interventions

DRUG

10mg XEN-D0103

DRUG

Placebo

DRUG

30mg XEN-D0103

DRUG

60mg XEN-D0103

DRUG

120mg XEN-D0103

DRUG

200mg XEN-D0103

DRUG

150mg XEN-D0103

Sponsors & Collaborators

  • Xention Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT02390258 on ClinicalTrials.gov