Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02778477
Previous Study | Return to List | Next Study

Topical Multiple Ascending Dose Study for PF-06423264

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02778477
Recruitment Status : Terminated (Preliminary analysis of accrued data failed to indicate any meaningful pharmacodynamic response.)
First Posted : May 20, 2016
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 17, 2016
First Posted Date  ICMJE May 20, 2016
Last Update Posted Date June 21, 2017
Actual Study Start Date  ICMJE May 23, 2016
Actual Primary Completion Date May 23, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2016)
  • Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) or other safety concerns [ Time Frame: Baseline (Day 0) up to 28 days after last dose of study medication ]
    Assessment by adverse event monitoring, 12 lead ECGs, telemetry, vital signs and clinical safety laboratory measurements. Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.
  • Number of Participants with Draize-like scoring and clinical observation [ Time Frame: Baseline (Day 1) up to Day 42+3 ]
    Modified Draize-like scoring and clinical observation. Severity estimated by clinical signs and scoring; ranged 0-4: 0= No reaction visible, 1= Trace reaction - barely perceptible pinkness, 2= Mild reaction - readily visible pinkness, 3= Moderate reaction - definite redness, 4= Strong to severe reaction - very intense redness.
  • Number of Participants With Clinical Laboratory Abnormalities [ Time Frame: Baseline (Day 0) up to 28 days after last dose ]
    Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick [urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin], microscopy [urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous [urine mucus and leucocytes]).
  • Number of Participants With Abnormal Electrocardiogram (ECG) [ Time Frame: Baseline (Day 0) up to 28 days after last dose ]
    Criteria for potential clinical concern in ECG parameters: Maximum QTcF interval (Fridericia's Correction) in range of 450 to less than 480 msec, maximum QTc interval increase from baseline in range of 30 to less than 60 msec and >=60 msec.
  • Number of Participants With Categorical Vital Signs Data [ Time Frame: Baseline (Day 0) up to 28 days after last dose ]
    Number of participants with maximum increase from Baseline in sitting SBP and DBP of greater than or equal to 30 mmHg was reported.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2016)
  • Maximum Observed Plasma Concentration (Cmax) for PF-06423264 [ Time Frame: 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24 hours post dose on Day 1 and 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24, 36, and 48 hours post dose on Day 14 ]
    Maximum Observed Plasma Concentration (Cmax)
  • Time to Reach Maximum Observed Concentration for PF-06423264 [ Time Frame: 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24 hours post dose on Day 1 and 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24, 36, and 48 hours post dose on Day 14 ]
    Time to Reach Maximum Observed Plasma Concentration (Tmax)
  • Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-06423264 [ Time Frame: 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24 hours post dose on Day 1 and 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24, 36, and 48 hours post dose on Day 14 ]
    Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours.
  • Plasma Decay Half-Life (t1/2) for PF-06423264 [ Time Frame: 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24 hours post dose on Day 1 and 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24, 36, and 48 hours post dose on Day 14 ]
    Plasma Decay Half-Life (t1/2)
  • Apparent Volume of Distribution (Vz/F) for PF-06423264 [ Time Frame: 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24 hours post dose on Day 1 and 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24, 36, and 48 hours post dose on Day 14 ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
  • Apparent Total Body Clearance (CL/F) for [ Time Frame: 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24 hours post dose on Day 1 and 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24, 36, and 48 hours post dose on Day 14 ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after apparent total body clearance is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
  • Observed Accumulation Ratio (Rac) for PF-06423264 [ Time Frame: 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24 hours post dose on Day 1 and 0, 0.5, 1, 2, 4, 5, 6, 8, 12, 24, 36, and 48 hours post dose on Day 14 ]
    Rac was calculated as, area under the curve from time zero to end of dosing interval on Day Y (AUCtau) divided by area under the curve from time zero to end of dosing interval on Day X(AUCtau).
  • change from baseline in sebum lipid components and sebum excretion [ Time Frame: Baseline (Day 0) up to 16 days after last dose of study medication ]
    change from baseline in sebum lipid components and sebum excretion as assessed with Sebutape strips and Sebumeter measurements on the forehead of subjects with oily skin
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Multiple Ascending Dose Study for PF-06423264
Official Title  ICMJE A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability And Pharmacokinetics Of Multiple Ascending Doses Of Pf-06423264 Administered Topically To Sequential Cohorts Of Healthy Subjects With And Without Oily Skin
Brief Summary The current study is the first clinical trial proposed with PF-06423264. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of multiple ascending doses of PF-06423264 to healthy adult subjects with or without oily skin.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Normal Healthy
Intervention  ICMJE
  • Drug: PF-06423264
    Multiple ascending dose of PF-06423264
  • Other: Placebo
    Multiple dose of placebo
    Other Name: Placebo comparator
Study Arms  ICMJE
  • Experimental: Part A_Cohort 1_Active
    Multiple ascending dose of PF-06423264
    Intervention: Drug: PF-06423264
  • Placebo Comparator: Part A_Cohort 1_Placebo
    Multiple dose of placebo
    Intervention: Other: Placebo
  • Experimental: Part A_Cohort 2_Active
    Multiple ascending dose of PF-06423264
    Intervention: Drug: PF-06423264
  • Placebo Comparator: Part A_Cohort 2_Placebo
    Multiple dose of placebo
    Intervention: Other: Placebo
  • Experimental: Part A_Cohort 3_Active
    Multiple ascending dose of PF-06423264
    Intervention: Drug: PF-06423264
  • Placebo Comparator: Part A_Cohort 3_Placebo
    Multiple dose of placebo
    Intervention: Other: Placebo
  • Experimental: Part A_Cohort 4_Active
    Multiple ascending dose of PF-06423264
    Intervention: Drug: PF-06423264
  • Placebo Comparator: Part A_Cohort 4_Placebo
    Multiple dose of placebo
    Intervention: Other: Placebo
  • Experimental: Part A_Cohort 5_Active
    Multiple ascending dose of PF-06423264
    Intervention: Drug: PF-06423264
  • Placebo Comparator: Part A_Cohort 5_Placebo
    Multiple dose of placebo
    Intervention: Other: Placebo
  • Experimental: Part A_Cohort 6_Active
    Multiple ascending dose of PF-06423264
    Intervention: Drug: PF-06423264
  • Placebo Comparator: Part A_Cohort 6_Placebo
    Multiple dose of placebo
    Intervention: Other: Placebo
  • Experimental: Part A_Cohort 7_Active
    Multiple ascending dose of PF-06423264
    Intervention: Drug: PF-06423264
  • Placebo Comparator: Part A_Cohort 7_Placebo
    Multiple ascending dose of placebo
    Intervention: Other: Placebo
  • Experimental: Part B_Cohort 1_Active
    Multiple doses of PF-06423264
    Intervention: Drug: PF-06423264
  • Placebo Comparator: Part B_Cohort 1_Placebo
    Multiple doses of placebo
    Intervention: Other: Placebo
  • Experimental: Part B_Cohort 2_Active
    Multiple doses of PF-06423264
    Intervention: Drug: PF-06423264
  • Placebo Comparator: Part B_Cohort 2_Placebo
    Multiple doses of placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 20, 2017)
65
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2016)
96
Actual Study Completion Date  ICMJE May 23, 2017
Actual Primary Completion Date May 23, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy males and female of non-childbearing potential;
  • Body Mass Index 17.5-35.5 kg/m2;
  • Body weight >50 kg;

Exclusion Criteria:

  • Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02778477
Other Study ID Numbers  ICMJE B7561002
2014-003736-39 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP