Relative Bioavailability Study of IX-01 Caplet Versus Aqueous Dispersion and Food Effect of the Caplet in Healthy Males
Public ClinicalTrials.gov record NCT02962531. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Single-Dose, 3-Way Crossover Study to Evaluate the Relative Bioavailability of the IX-01 Caplet Formulation Compared With the IX 01 Aqueous Dispersion Formulation, and the Effect of Food on the IX-01 Caplet Formulation, in Healthy Male Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT02962531
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 12 participants
Conditions and interventions
Conditions
Interventions
- IX-01 caplets 1600 mg (4 x 400 mg), fasted Drug
- IX-01 caplets 1600 mg (4 x 400 mg), fed Drug
- IX-01 aqueous dispersion 1600 mg (20 mL), fasted Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- Male
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2016 (Type not available)
- Primary completion
- Dec 2016 (Actual)
- Completion
- Dec 2016 (Actual)
- Last update posted
- Jan 13, 2017
2016
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Worldwide Clinical Trials Early Phase Services, LLC | San Antonio | Texas | 78217 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02962531, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 13, 2017 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02962531 live on ClinicalTrials.gov.