NCT02101216 is a Phase 1 clinical trial of Prurisol in Psoriasis, sponsored by Cellceutix Corporation.

Who is sponsoring NCT02101216?

NCT02101216 is sponsored by Cellceutix Corporation.

What drugs are being tested in NCT02101216?

Interventions in NCT02101216: Prurisol, Ziagen.

Is NCT02101216 still recruiting?

NCT02101216 is currently completed. Last updated 24 October 2018.

Last reviewed 2018-10-24 · How we verify

NCT02101216

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 24 October 2018

What this trial tests

Phase 1 trial testing Prurisol in Psoriasis in 18 participants. Completed in 1 October 2014.

Timeline

1 March 2014

Primary endpoint
1 July 2014

1 October 2014

Quick facts

Lead sponsor	Cellceutix Corporation
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	18
Start date	1 March 2014
Primary completion	1 July 2014
Estimated completion	1 October 2014
Sites	1 location across United States

Drugs / interventions tested

Prurisol — full drug profile →
Ziagen (ABACAVIR) — full drug profile →

Conditions studied

Psoriasis — all drugs for Psoriasis →

Sponsor

Cellceutix Corporation — full company profile →

Who can join

Adults 18 to 65, any sex, with Psoriasis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Area under the plasma concentration versus time curve (AUC) of abacavir derived from Prurisol and Ziagen
Time frame: 24 hours after second and third dose of study drug or reference drug
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 l
Peak plasma concentration (Cmax) of abacavir derived from Prurisol and Ziagen
Time frame: 24 hours after second and third dose of study drug or reference drug
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 l
Time to Cmax (Tmax) of abacavir derived from Prurisol and Ziagen
Time frame: 24 hours after second and third dose of study drug or reference drug
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 l

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Psoriasis

Currently open trials in the same condition.

NCT07471048 — A Study to Evaluate the Impact of a Magnolia Officinalis Dietary Supplement on Immune Biomarkers in Subjects With Psoria · NA · recruiting
NCT07449234 — A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis · recruiting
NCT07234838 — Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO) · recruiting
NCT07194200 — Safety and Efficacy of Lactobacillus Plantarum for Psoriasis: A Randomized Double-Blind Placebo-Controlled Trial · Phase 2 · recruiting
NCT07250997 — PALLAS Laser for Skin Diseases · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02101216 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cellceutix Corporation
Last refreshed: 24 October 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02101216.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing