Clinical trial NCT02778477: Topical Multiple Ascending Dose Study for PF-06423264
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Normal Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-05-20
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) or other safety concerns
timeFrame: Baseline (Day 0) up to 28 days after last dose of study medication
measure: Number of Participants with Draize-like scoring and clinical observation
timeFrame: Baseline (Day 1) up to Day 42+3
measure: Number of Participants With Clinical Laboratory Abnormalities
timeFrame: Baseline (Day 0) up to 28 days after last dose
measure: Number of Participants With Abnormal Electrocardiogram (ECG)
timeFrame: Baseline (Day 0) up to 28 days after last dose
measure: Number of Participants With Categorical Vital Signs Data
timeFrame: Baseline (Day 0) up to 28 days after last dose
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) for PF-06423264
timeFrame: 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
measure: Time to Reach Maximum Observed Concentration for PF-06423264
timeFrame: 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
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-06423264
timeFrame: 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
measure: Plasma Decay Half-Life (t1/2) for PF-06423264
timeFrame: 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
measure: Apparent Volume of Distribution (Vz/F) for PF-06423264
timeFrame: 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
measure: Apparent Total Body Clearance (CL/F) for
timeFrame: 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
measure: Observed Accumulation Ratio (Rac) for PF-06423264
timeFrame: 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
measure: change from baseline in sebum lipid components and sebum excretion
timeFrame: Baseline (Day 0) up to 16 days after last dose of study medication
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: