Topical Multiple Ascending Dose Study for PF-06423264

NCT02778477 | Terminated Phase 1

• 2 other identifiers: B75610022014-003736-39
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal Healthy

Outcome Measures

Primary Outcomes (5)

• Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) or other safety concerns

  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.

  Baseline (Day 0) up to 28 days after last dose of study medication

• Number of Participants with Draize-like scoring and clinical observation

  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.

  Baseline (Day 1) up to Day 42+3

• Number of Participants With Clinical Laboratory Abnormalities

  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 \[urine mucus and leucocytes\]).

  Baseline (Day 0) up to 28 days after last dose

• Number of Participants With Abnormal Electrocardiogram (ECG)

  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.

  Baseline (Day 0) up to 28 days after last dose

• Number of Participants With Categorical Vital Signs Data

  Number of participants with maximum increase from Baseline in sitting SBP and DBP of greater than or equal to 30 mmHg was reported.

  Baseline (Day 0) up to 28 days after last dose

Secondary Outcomes (8)

• Maximum Observed Plasma Concentration (Cmax) for PF-06423264

  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 Concentration for PF-06423264

  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 Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-06423264

  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) for PF-06423264

  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

• Apparent Volume of Distribution (Vz/F) for PF-06423264

  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

Study Arms (18)

Part A_Cohort 1_Active

EXPERIMENTAL

Multiple ascending dose of PF-06423264

Drug: PF-06423264

Part A_Cohort 1_Placebo

PLACEBO COMPARATOR

Multiple dose of placebo

Other: Placebo

Part A_Cohort 2_Active

EXPERIMENTAL

Multiple ascending dose of PF-06423264

Drug: PF-06423264

Part A_Cohort 2_Placebo

PLACEBO COMPARATOR

Multiple dose of placebo

Other: Placebo

Part A_Cohort 3_Active

EXPERIMENTAL

Multiple ascending dose of PF-06423264

Drug: PF-06423264

Part A_Cohort 3_Placebo

PLACEBO COMPARATOR

Multiple dose of placebo

Other: Placebo

Part A_Cohort 4_Active

EXPERIMENTAL

Multiple ascending dose of PF-06423264

Drug: PF-06423264

Part A_Cohort 4_Placebo

PLACEBO COMPARATOR

Multiple dose of placebo

Other: Placebo

Part A_Cohort 5_Active

EXPERIMENTAL

Multiple ascending dose of PF-06423264

Drug: PF-06423264

Part A_Cohort 5_Placebo

PLACEBO COMPARATOR

Multiple dose of placebo

Other: Placebo

Part A_Cohort 6_Active

EXPERIMENTAL

Multiple ascending dose of PF-06423264

Drug: PF-06423264

Part A_Cohort 6_Placebo

PLACEBO COMPARATOR

Multiple dose of placebo

Other: Placebo

Part A_Cohort 7_Active

EXPERIMENTAL

Multiple ascending dose of PF-06423264

Drug: PF-06423264

Part A_Cohort 7_Placebo

PLACEBO COMPARATOR

Multiple ascending dose of placebo

Other: Placebo

Part B_Cohort 1_Active

EXPERIMENTAL

Multiple doses of PF-06423264

Drug: PF-06423264

Part B_Cohort 1_Placebo

PLACEBO COMPARATOR

Multiple doses of placebo

Other: Placebo

Part B_Cohort 2_Active

EXPERIMENTAL

Multiple doses of PF-06423264

Drug: PF-06423264

Part B_Cohort 2_Placebo

PLACEBO COMPARATOR

Multiple doses of placebo

Other: Placebo

Interventions

PF-06423264 DRUG

Multiple ascending dose of PF-06423264

Part A_Cohort 1_Active; Part A_Cohort 2_Active; Part A_Cohort 3_Active; Part A_Cohort 4_Active; Part A_Cohort 5_Active; Part A_Cohort 6_Active; Part A_Cohort 7_Active; Part B_Cohort 1_Active; Part B_Cohort 2_Active

Placebo OTHER

Multiple dose of placebo

Also known as: Placebo comparator

Part A_Cohort 1_Placebo; Part A_Cohort 2_Placebo; Part A_Cohort 3_Placebo; Part A_Cohort 4_Placebo; Part A_Cohort 5_Placebo; Part A_Cohort 6_Placebo; Part A_Cohort 7_Placebo; Part B_Cohort 1_Placebo; Part B_Cohort 2_Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.
• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 20, 2016
• Study Start: May 23, 2016
• Primary Completion: May 23, 2017
• Study Completion: May 23, 2017
• Last Updated: June 21, 2017

Record last verified: 2017-06

Locations

BE (1)