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Relative Bioavailability Study of IX-01 Caplet Versus Aqueous Dispersion and Food Effect of the Caplet in Healthy Males
NCT02962531 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG 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
Study Locations (1)
Texas
- Worldwide Clinical Trials Early Phase Services, LLC — San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2016-11 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02962531
The ClinicalTrials.gov registry entry for NCT02962531 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ixchelsis Limited, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 3 interventions — of which IX-01 caplets 1600 mg (4 x 400 mg), fasted is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02962531 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02962531 about?
NCT02962531 is a clinical study titled "Relative Bioavailability Study of IX-01 Caplet Versus Aqueous Dispersion and Food Effect of the Caplet in Healthy Males". 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
What is the current status of trial NCT02962531?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2016-11. Estimated completion is 2016-12.
What conditions does trial NCT02962531 study?
This clinical trial studies the following conditions: Healthy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02962531?
The interventions under investigation include: 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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02962531?
This trial is sponsored by Ixchelsis Limited, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02962531 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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