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Relative Bioavailability Study of IX-01 Caplet Versus Aqueous Dispersion and Food Effect of the Caplet in Healthy Males

NCT02962531 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-01-13

No results posted yet for this study

Summary

An open-label, randomized, three-period, three-way crossover trial of single doses of IX-01 in 12 healthy male subjects. In each period, subjects will receive a single oral dose of 1600 mg IX-01, either as an aqueous dispersion in a fasted state, or as caplets in the fed or fasted state

Conditions

  • Healthy

Interventions

DRUG

IX-01 caplets 1600 mg (4 x 400 mg), fasted

oral dose under fasted conditions

DRUG

IX-01 caplets 1600 mg (4 x 400 mg), fed

oral dose under fed conditions

DRUG

IX-01 aqueous dispersion 1600 mg (20 mL), fasted

oral dose under fasted conditions

Sponsors & Collaborators

  • Ixchelsis Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

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 NCT02962531 on ClinicalTrials.gov