PsoriasisPhase 1NCT02101216
Bioequivalence and Pharmacokinetic Study of Prurisol™ and Abacavir Sulfate in Healthy Volunteers
A Phase 1 study testing Prurisol and Ziagen in people with Psoriasis, run by Cellceutix Corporation at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Prurisol and Ziagen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Oct 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 30Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Phase One Solutions Inc.
Miami Gardens, Florida, 33169
About this study
Official title: 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 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.
Read the detailed description
Prurisol™, abacavir acetate, is an ester of abacavir. Prurisol is believed to act as an immune response modifier in certain conditions, including psoriasis. Abacavir is a synthetic nucleoside analogue. Ziagen, abacavir sulfate, was developed and marketed as a treatment for HIV-1 infection for over a decade. Ziagen inhibits viral DNA synthesis. Consequently, Prurisol is under consideration as a possible new therapy for moderate to severe plaque psoriasis. The nonclinical efficacy of Prurisol has been demonstrated in the human psoriatic skin xenograft model in irradiated severe combined immune deficient mice. Histologic as well as visual observations confirmed a treatment benefit of Prurisol in this animal model. Interleukin-20 (IL-20) is a recently discovered cytokine displaying increased levels in psoriatic lesions, and levels of IL-20 have been shown to decrease with anti-psoriasis treatment and correlate with clinical improvement. IL-20 has been suggested as a specific target in psoriasis treatment. In comparison to vehicle-treated animals, the mice transplanted with human psoriatic tissue and treated with Prurisol had significant reductions in plasma IL-20 levels which were greater than those seen with methotrexate treatment. The expression of PRINS (psoriasis susceptibility-related RNA gene induced by stress) was significantly lower with twice daily Prurisol treatment compared to control.
This study is designed as an open-label, randomized, 2-period, 2-treatment, 2-sequence, single-dose intensive pharmacokinetic (PK) study conducted in healthy volunteers. In addition, a lead-in dosing period will allow the evaluation of the PK of abacavir from 3 escalating single doses of Prurisol (50mg, 100mg, 200mg). Completion of each dosing cohort will be followed by a 24-hour safety evaluation period before moving to a higher dose. Adverse Events, vital signs, physical examination, and safety laboratory tests (clinical chemistry and hematology) from each dosed cohort will be reviewed prior to any dose escalation for next cohort.
For each subject completing the first part, there will be a 5 to 21 day washout period before the next dose of study drug. Subjects will be randomly assigned to receive either a single dose of 350mg Prurisol or 300mg of Ziagen in the second dosing period. After a 5 to 21 day washout period, subjects will receive the alternate treatment in the third dosing period.
Blood samples for PK analysis will be obtained over a 24 hour period for each dose. Safety and tolerability will be assessed by ascertainment of adverse events, results of clinical laboratory testing and physical examination.
- Conditions
- Psoriasis
- Being tested
- Prurisol, Ziagen
- Keywords
- bioequivalence, pharmacokinetics, psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrurisolDrug
Also called abacavir acetate
Experimental Drug
ZiagenDrug
Also called abacavir sulfate
Active comparator
| Study group | Role | What they receive |
|---|---|---|
| Pharmacokinetics of low dose Prurisol | Experimental | Pharmacokinetics of single dose of Prurisol™ 50 mg (1 tablets) to 6 subjects Receives: Drug: Prurisol |
| Pharmacokinetics medium dose Prurisol | Experimental | Pharmacokinetics of single dose of Prurisol™ 100 mg (2 tablets) to 6 subjects Receives: Drug: Prurisol |
| Pharmacokinetics of high dose Prurisol | Experimental | Pharmacokinetics of single dose of Prurisol™ 200 mg (4 tablets) to 6 subjects Receives: Drug: Prurisol |
| Bioequivalence of Prurisol (350 mg) | Experimental | Single dose of Prurisol™ 350 mg (7 x 50 mg tablets) Receives: Drug: Prurisol |
| Bioequivalence of Ziagen (300 mg) | Active comparator | Single dose of Ziagen 300 mg (1 x 300mg tablet) Receives: Drug: Ziagen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) of abacavir derived from Prurisol and Ziagen
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 will be those who received both alternate treatments and for whom an adequate number of post-dose PK sample results are available.
Measured: 24 hours after second and third dose of study drug or reference drug
Peak plasma concentration (Cmax) of abacavir derived from Prurisol and Ziagen
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 will be those who received both alternate treatments and for whom an adequate number of post-dose PK sample results are available.
Measured: 24 hours after second and third dose of study drug or reference drug
Time to Cmax (Tmax) of abacavir derived from Prurisol and Ziagen
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 will be those who received both alternate treatments and for whom an adequate number of post-dose PK sample results are available.
Measured: 24 hours after second and third dose of study drug or reference drug
Secondary outcomes (7)
Area under the plasma concentration versus time curve (AUC) of abacavir derived from Prurisol
Pharmacokinetic parameters (AUC, Cmax, Tmax, t1/2) of abacavir derived from Prurisol will be determined in Part A of this study. Three cohorts, each comprising 6 subjects, will be administered escalating single doses of Prurisol.
Part A consists of single doses of open-label Prurisol at doses of 50mg (1 tablet), 100mg (2 tablets) and 200 mg (4 tablets) administered to approximately equal numbers of male and female subjects. These treatments will be administered in 3 sequential cohorts with at least a 24 hour interval (safety period) between subjects in each of the 3 cohorts.
Plasma concentrations of abacavir will be assayed by a validated liquid chromatography-mass spectrometry (LC/MS/MS) method and PK parameters will be calculated.
Measured: 0 to 24 hours after the first dose of study drug
Peak plasma concentration (Cmax) of abacavir derived from Prurisol
Pharmacokinetic parameters (AUC, Cmax, Tmax, t1/2) of abacavir derived from Prurisol will be determined in Part A of this study. Three cohorts, each comprising 6 subjects, will be administered escalating single doses of Prurisol.
Part A consists of single doses of open-label Prurisol at doses of 50mg (1 tablet), 100mg (2 tablets) and 200 mg (4 tablets) administered to approximately equal numbers of male and female subjects. These treatments will be administered in 3 sequential cohorts with at least a 24 hour interval (safety period) between subjects in each of the 3 cohorts.
Plasma concentrations of abacavir will be assayed by a validated liquid chromatography-mass spectrometry (LC/MS/MS) method and PK parameters will be calculated.
Measured: 0 to 24 hours after the first dose of study drug
Time to Cmax (Tmax) of abacavir derived from Prurisol
Pharmacokinetic parameters (AUC, Cmax, Tmax, t1/2) of abacavir derived from Prurisol will be determined in Part A of this study. Three cohorts, each comprising 6 subjects, will be administered escalating single doses of Prurisol.
Part A consists of single doses of open-label Prurisol at doses of 50mg (1 tablet), 100mg (2 tablets) and 200 mg (4 tablets) administered to approximately equal numbers of male and female subjects. These treatments will be administered in 3 sequential cohorts with at least a 24 hour interval (safety period) between subjects in each of the 3 cohorts.
Plasma concentrations of abacavir will be assayed by a validated liquid chromatography-mass spectrometry (LC/MS/MS) method and PK parameters will be calculated.
Measured: 0 to 24 hours after the first dose of study drug
Elimination half-life (t1/2) of abacavir derived from Prurisol
Pharmacokinetic parameters (AUC, Cmax, Tmax, t1/2) of abacavir derived from Prurisol will be determined in Part A of this study. Three cohorts, each comprising 6 subjects, will be administered escalating single doses of Prurisol.
Part A consists of single doses of open-label Prurisol at doses of 50mg (1 tablet), 100mg (2 tablets) and 200 mg (4 tablets) administered to approximately equal numbers of male and female subjects. These treatments will be administered in 3 sequential cohorts with at least a 24 hour interval (safety period) between subjects in each of the 3 cohorts.
Plasma concentrations of abacavir will be assayed by a validated liquid chromatography-mass spectrometry (LC/MS/MS) method and PK parameters will be calculated.
Measured: 0 to 24 hours after the first dose of study drug
Number of participants with adverse events
To evaluate the safety and tolerability of Prurisol in healthy volunteers, completion of each dosing cohort will be followed by a 24-hour safety evaluation period before moving to a higher dose. Adverse events from each dosed cohort will be reviewed prior to any dose escalation for next cohort.
For each subject completing their first treatment, there will be a 5 to 21 day washout period before being given the next dose of study drug. Subjects completing their first treatment will be randomly assigned to receive either Prurisol or Ziagen in the second dosing period. After a 5-21 day washout period, subjects will receive the alternate treatment (Ziagen or Prurisol) in the third dosing period.
The sequential dosing specified will allow for observation of any possible adverse effects of Prurisol at the respective doses.
Measured: Day 1, Day 2, Day 3
Number of participants with vital sign changes
To evaluate the safety and tolerability of Prurisol in healthy volunteers, completion of each dosing cohort will be followed by a 24-hour safety evaluation period before moving to a higher dose. Vital signs from each dosed cohort will be reviewed prior to any dose escalation for next cohort.
For each subject completing their first treatment, there will be a 5 to 21 day washout period before being given the next dose of study drug. Subjects completing their first treatment will be randomly assigned to receive either Prurisol or Ziagen in the second dosing period. After a 5-21 day washout period, subjects will receive the alternate treatment (Ziagen or Prurisol) in the third dosing period.
The sequential dosing specified will allow for observation of any possible adverse effects of Prurisol at the respective doses.
Measured: Day 1, Day 2, Day 3
Number of participants with changes in standard laboratory tests
To evaluate the safety and tolerability of Prurisol in healthy volunteers, completion of each dosing cohort will be followed by a 24-hour safety evaluation period before moving to a higher dose. Laboratory tests (standard hematology and clinical chemistry panels) from each dosed cohort will be reviewed prior to any dose escalation for next cohort.
For each subject completing their first treatment, there will be a 5 to 21 day washout period before being given the next dose of study drug. Subjects completing their first treatment will be randomly assigned to receive either Prurisol or Ziagen in the second dosing period. After a 5-21 day washout period, subjects will receive the alternate treatment (Ziagen or Prurisol) in the third dosing period.
The sequential dosing specified will allow for observation of any possible adverse effects of Prurisol at the respective doses.
Measured: Day 1, Day 2, Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellceutix Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Krishna Menon, Study director, Cellceutix Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101216
- Sponsor's protocol ID
- CTIX-14-03
- Status last verified
- Oct 2018
- First submitted
- 24 Mar 2014
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Foster RH, Faulds D. Abacavir. Drugs. 1998 May;55(5):729-36; discussion 737-8. doi: 10.2165/00003495-199855050-00018.
PubMed 9585869Galadari I, Rigel E, Lebwohl M. The cost of psoriasis treatment. J Eur Acad Dermatol Venereol. 2001 Jul;15(4):290-1. No abstract available.
PubMed 11730031Hetherington S, McGuirk S, Powell G, Cutrell A, Naderer O, Spreen B, Lafon S, Pearce G, Steel H. Hypersensitivity reactions during therapy with the nucleoside reverse transcriptase inhibitor abacavir. Clin Ther. 2001 Oct;23(10):1603-14. doi: 10.1016/s0149-2918(01)80132-6.
PubMed 11726000Imamichi T. Action of anti-HIV drugs and resistance: reverse transcriptase inhibitors and protease inhibitors. Curr Pharm Des. 2004;10(32):4039-53. doi: 10.2174/1381612043382440.
PubMed 15579086Sonkoly E, Bata-Csorgo Z, Pivarcsi A, Polyanka H, Kenderessy-Szabo A, Molnar G, Szentpali K, Bari L, Megyeri K, Mandi Y, Dobozy A, Kemeny L, Szell M. Identification and characterization of a novel, psoriasis susceptibility-related noncoding RNA gene, PRINS. J Biol Chem. 2005 Jun 24;280(25):24159-67. doi: 10.1074/jbc.M501704200. Epub 2005 Apr 26.
PubMed 15855153Tzu J, Kerdel F. From conventional to cutting edge: the new era of biologics in treatment of psoriasis. Dermatol Ther. 2008 Mar-Apr;21(2):131-41. doi: 10.1111/j.1529-8019.2008.00180.x.
PubMed 18394087
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02101216
- Acronym / sponsor ID
- CTIX-14-03
- Conditions
- Psoriasis
- Keywords
- bioequivalence, pharmacokinetics, psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cellceutix CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prurisol™, abacavir acetate, is an ester of abacavir. Prurisol is believed to act as an immune response modifier in certain conditions, including psoriasis. Abacavir is a synthetic nucleoside analogue. Ziagen, abacavir sulfate, was developed and marketed as a treatment for HIV-1 infection for over a decade. Ziagen inhibits viral DNA synthesis. Consequently, Prurisol is under consideration as a possible new therapy for moderate to severe plaque psoriasis. The nonclinical efficacy of Prurisol has been demonstrated in the human psoriatic skin xenograft model in irradiated severe combined immune deficient mice. Histologic as well as visual observations confirmed a treatment benefit of Prurisol in this animal model. Interleukin-20 (IL-20) is a recently discovered cytokine displaying increased levels in psoriatic lesions, and levels of IL-20 have been shown to decrease with anti-psoriasis treatment and correlate with clinical improvement. IL-20 has been suggested as a specific target in psoriasis treatment. In comparison to vehicle-treated animals, the mice transplanted with human psoriatic tissue and treated with Prurisol had significant reductions in plasma IL-20 levels which were greater than those seen with methotrexate treatment. The expression of PRINS (psoriasis susceptibility-related RNA gene induced by stress) was significantly lower with twice daily Prurisol treatment compared to control.
This study is designed as an open-label, randomized, 2-period, 2-treatment, 2-sequence, single-dose intensive pharmacokinetic (PK) study conducted in healthy volunteers. In addition, a lead-in dosing period will allow the evaluation of the PK of abacavir from 3 escalating single doses of Prurisol (50mg, 100mg, 200mg). Completion of each dosing cohort will be followed by a 24-hour safety evaluation period before moving to a higher dose. Adverse Events, vital signs, physical examination, and safety laboratory tests (clinical chemistry and hematology) from each dosed cohort will be reviewed prior to any dose escalation for next cohort.
For each subject completing the first part, there will be a 5 to 21 day washout period before the next dose of study drug. Subjects will be randomly assigned to receive either a single dose of 350mg Prurisol or 300mg of Ziagen in the second dosing period. After a 5 to 21 day washout period, subjects will receive the alternate treatment in the third dosing period.
Blood samples for PK analysis will be obtained over a 24 hour period for each dose. Safety and tolerability will be assessed by ascertainment of adverse events, results of clinical laboratory testing and physical examination.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pharmacokinetics of low dose Prurisol | Experimental | Drug: PrurisolPharmacokinetics of single dose of Prurisol™ 50 mg (1 tablets) to 6 subjects |
| Pharmacokinetics medium dose Prurisol | Experimental | Drug: PrurisolPharmacokinetics of single dose of Prurisol™ 100 mg (2 tablets) to 6 subjects |
| Pharmacokinetics of high dose Prurisol | Experimental | Drug: PrurisolPharmacokinetics of single dose of Prurisol™ 200 mg (4 tablets) to 6 subjects |
| Bioequivalence of Prurisol (350 mg) | Experimental | Drug: PrurisolSingle dose of Prurisol™ 350 mg (7 x 50 mg tablets) |
| Bioequivalence of Ziagen (300 mg) | Active comparator | Drug: ZiagenSingle dose of Ziagen 300 mg (1 x 300mg tablet) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrurisolAlso: abacavir acetateExperimental Drug | Drug | Bioequivalence of Prurisol (350 mg), Pharmacokinetics medium dose Prurisol, Pharmacokinetics of high dose Prurisol, Pharmacokinetics of low dose Prurisol |
| ZiagenAlso: abacavir sulfateActive comparator | Drug | Bioequivalence of Ziagen (300 mg) |
Primary outcome
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 later, each subject will receive the alternate study drug. Evaluable subjects in the PK population will be those who received both alternate treatments and for whom an adequate number of post-dose PK sample results are available.
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 later, each subject will receive the alternate study drug. Evaluable subjects in the PK population will be those who received both alternate treatments and for whom an adequate number of post-dose PK sample results are available.
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 later, each subject will receive the alternate study drug. Evaluable subjects in the PK population will be those who received both alternate treatments and for whom an adequate number of post-dose PK sample results are available.
7 secondary outcomes
Area under the plasma concentration versus time curve (AUC) of abacavir derived from Prurisol
Time frame: 0 to 24 hours after the first dose of study drug
Peak plasma concentration (Cmax) of abacavir derived from Prurisol
Time frame: 0 to 24 hours after the first dose of study drug
Time to Cmax (Tmax) of abacavir derived from Prurisol
Time frame: 0 to 24 hours after the first dose of study drug
Elimination half-life (t1/2) of abacavir derived from Prurisol
Time frame: 0 to 24 hours after the first dose of study drug
Number of participants with adverse events
Time frame: Day 1, Day 2, Day 3
Number of participants with vital sign changes
Time frame: Day 1, Day 2, Day 3
Number of participants with changes in standard laboratory tests
Time frame: Day 1, Day 2, Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Background: PubMed 9585869Foster RH, Faulds D. Abacavir. Drugs. 1998 May;55(5):729-36; discussion 737-8. doi: 10.2165/00003495-199855050-00018.
- Background: PubMed 11730031Galadari I, Rigel E, Lebwohl M. The cost of psoriasis treatment. J Eur Acad Dermatol Venereol. 2001 Jul;15(4):290-1. No abstract available.
- Background: PubMed 11726000Hetherington S, McGuirk S, Powell G, Cutrell A, Naderer O, Spreen B, Lafon S, Pearce G, Steel H. Hypersensitivity reactions during therapy with the nucleoside reverse transcriptase inhibitor abacavir. Clin Ther. 2001 Oct;23(10):1603-14. doi: 10.1016/s0149-2918(01)80132-6.
- Background: PubMed 15579086Imamichi T. Action of anti-HIV drugs and resistance: reverse transcriptase inhibitors and protease inhibitors. Curr Pharm Des. 2004;10(32):4039-53. doi: 10.2174/1381612043382440.
- Background: PubMed 15855153Sonkoly E, Bata-Csorgo Z, Pivarcsi A, Polyanka H, Kenderessy-Szabo A, Molnar G, Szentpali K, Bari L, Megyeri K, Mandi Y, Dobozy A, Kemeny L, Szell M. Identification and characterization of a novel, psoriasis susceptibility-related noncoding RNA gene, PRINS. J Biol Chem. 2005 Jun 24;280(25):24159-67. doi: 10.1074/jbc.M501704200. Epub 2005 Apr 26.
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- Ziagen® Highlights of Prescribing InformationLink provided by the sponsor.
- Ziagen® NDA # 020977 (December 1998),Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krishna Menon study director
Cellceutix Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Prurisol and Ziagen in people with Psoriasis, run by Cellceutix Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02101216, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2018.