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NCT02962531 · ClinicalTrials.gov registry record · Phase 1
Relative Bioavailability Study of IX-01 Caplet Versus Aqueous Dispersion and Food Effect of the Caplet in Healthy Males
A Phase 1 study of Healthy, sponsored by Ixchelsis Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT02962531: Completed Phase 1 study of Healthy, sponsored by Ixchelsis Limited.
NCT02962531 is a Phase 1 study of Healthy that has completed, run by Ixchelsis Limited. The registered enrollment target is 12 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02962531, a Phase 1 study of Healthy, has completed, sponsored by Ixchelsis Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The listed sponsor is Ixchelsis Limited, which has 3 total studies on file at ClinicalTrials.gov.
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.
NCT02962531 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
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.
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).
Who is sponsoring clinical trial NCT02962531?
This trial is sponsored by Ixchelsis Limited, which has 3 total clinical trials registered on ClinicalTrials.gov.
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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Related
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