CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
Prurisol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02101216
NCT02101216Phase 1Completed

A Randomized, Open-Label, Single-Dose, 2 Period Crossover Pharmacokinetic and Bioequivalence Study, With a Lead-In Dose Period, Evaluating Oral Abacavir Acetate (Prurisol™) and Oral Abacavir Sulfate (Ziagen®) in Healthy Volunteers

Cellceutix Corporation·interventional·Posted Apr 2, 2014·Updated Oct 26, 2018

In Brief

A Phase 1 clinical trial evaluating Prurisol and Ziagen for Psoriasis. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2, 2014
Enrollment StartMar 1, 2014
Primary CompletionJul 1, 2014
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.3 years ago

Interventions

Prurisoldrug

Experimental Drug

Ziagendrug

Active comparator