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NCT02101216 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence and Pharmacokinetic Study of Prurisol™ and Abacavir Sulfate in Healthy Volunteers
A Phase 1 study, sponsored by Cellceutix Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT02101216: Completed Phase 1 study, sponsored by Cellceutix Corporation.
NCT02101216 is a Phase 1 study that has completed, run by Cellceutix Corporation. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02101216, a Phase 1 study, has completed, sponsored by Cellceutix Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
Cellceutix Corporation has created a new chemical entity for the treatment of psoriasis, termed Prurisol™, which is an ester of abacavir. This first-in-human study of Prurisol (abacavir acetate) is being performed to evaluate the pharmacokinetics, safety and tolerance of a single oral doses of Prurisol administered to healthy volunteers and the bioequivalence to abacavir sulfate (Ziagen). This study will be followed by a 505(b)(2) Phase 2 trial in patients with moderate to severe plaque psoriasis.
Primary Outcome
Part B of the study will determine the average bioequivalence of abacavir derived from Prurisol (abacavir acetate) 350mg compared with abacavir derived from the commercially available tablet formulation of Ziagen (abacavir sulfate) 300mg. After completion of Part A, subjects will be randomly assigned to cross-over treatment sequence Prurisol then Ziagen, or Ziagen then Prurisol. Five to 21 days later, each subject will receive the alternate study drug. Evaluable subjects in the PK population wi
Interventions
- DRUG Ziagen
- DRUG Prurisol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2014-03 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
What the finished NCT02101216 record still lists
NCT02101216 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Ziagen is the first listed.
NCT02101216 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02101216 about?
NCT02101216 is a clinical study titled "Bioequivalence and Pharmacokinetic Study of Prurisol™ and Abacavir Sulfate in Healthy Volunteers". Cellceutix Corporation has created a new chemical entity for the treatment of psoriasis, termed Prurisol™, which is an ester of abacavir. This first-in-human study of Prurisol (abacavir acetate) is being performed to evaluate the pharmacokinetics, safety and tolerance of a single oral doses of Pruri...
What is the current status of trial NCT02101216?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2014-03. Estimated completion is 2014-10.
What interventions are being tested in trial NCT02101216?
The interventions under investigation include: Ziagen (DRUG), Prurisol (DRUG).
Who is sponsoring clinical trial NCT02101216?
This trial is sponsored by Cellceutix Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02101216's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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