Bioequivalence and Pharmacokinetic Study of Prurisol™ and Abacavir Sulfate in Healthy Volunteers

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cellceutix Corporation
• Treatments: Abacavir; Dideoxynucleosides

Criteria

Inclusion Criteria:

Individuals who meet ALL of the following criteria are eligible for participation in this study:

• Provided written informed consent

• Male or female adult aged 18-65 years old (inclusive). At least 20% of enrolled subjects will be aged 55-65 years, inclusive. Effort will be made to enroll equivalent numbers of males and females

• BMI of 19-32 kg/m2

• Identified as a non-smoker at the Consent/Screening Visit. A urine cotinine test will be performed at screening and during each clinic check-in before for each of the three Treatment Visits

• Willing and able to comply with all aspects of the study protocol including avoiding use of certain concomitant medications and attending the required clinic visits

Exclusion Criteria:

Subjects are not eligible for participation in the study if any of the following criteria are met:

• Females of childbearing potential not using reliable contraception, (e.g., abstinence, double barrier method, oral/implantable/transdermal contraception. Depo-provera, intrauterine device)

• Female who is pregnant, lactating, has a positive serum pregnancy test drawn at the Consent/Screening Visit, or has a positive urine pregnancy test at check-in performed prior to any of the 3 Treatment Days

• Presence of any uncontrolled (in the Investigator's medical opinion) systemic disease, including, but not limited to renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or psychiatric disease

• History of any immune disorder, or disease/condition potentially affecting the immune system

• Regular use of oral or parenteral corticosteroids (inhaled corticosteroids for stable asthma or chronic obstructive pulmonary disease are permitted)

• ECG obtained at Consent/Screening Visit which shows medically significant abnormalities (e.g. bundle branch block, frequent premature ventricular contractions, corrected QT interval (QTc) prolongation >450 msec for males and >470 msec for females)

• Presence of a condition that makes it unlikely that the requirements of the protocol will be completed

• Urine screening test(s) positive for evidence of amphetamines, barbiturates, benzodiazepines, cocaine, methamphetamine, opiates, phencyclidine, marijuana

• Positive urine cotinine test

• Positive breath alcohol test

• History of hypersensitivity to any formulation of abacavir

• Previous treatment with any abacavir-containing product

• Current participation or participation in a drug/device or biologic investigational research study within 30 days prior to the Treatment A Visit

• An elective surgical or medical procedure is planned or scheduled to be performed during the period of the study

• Past surgical history of any degree of gastric resection or gastric banding

• History of a clinically diagnosed upper respiratory tract infection or any acute illness requiring antibiotic therapy within 14 days prior to the Treatment A Visit

• Systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg or heart rate <45 bpm in a subject under the age of 40 years and heart rate <50 bpm in a subject aged ≥40 years or >100 bpm (any subject age) on repeat determinations at the Consent/Screening Visit or at check-in on the day prior to each of the 3 Treatment Days and at pre-dose if drug administered on different day than check-in

• Clinical laboratory results at the Consent/Screening Visit that show any one or more of the following:

• Hemoglobin <11 Gm/dL, Hematocrit<30%

• Total white blood cell count <3000cells/mm3

• Absolute neutrophil count <1500cells/mm3

• Platelet count <100,000/mm3

• alanine aminotransferase or aspartate aminotransferase >1.5 x Upper Limit of Normal (ULN)

• Serum amylase above ULN

• Serum creatinine >1.5 x ULN

• Positive serum human chorionic gonadotropin

• Positive serologic test for HBsAg, HIV, hepatitis C virus

• Positive test for HLA-B*5701 allele by certified laboratory

• Urinalysis showing medically significant abnormality