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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
Primary Outcome
Relative bioavailability of the caplet formulation of IX-01compared with the aqueous dispersion formulation when administered in the 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 |
What the finished NCT02962531 record still lists
NCT02962531 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02962531's enrollment target sits among peer trials
12 996th of 1090 higher than 61 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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