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NCT02855177 Clinical Trial

A Multiple Dose Safety And Pharmacokinetic (PK) Study Of PF-06427878 In Overweight-Obese, Otherwise Healthy Subjects

Healthy Volunteers Clinical Trial

Official title:
A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel-group Study To Assess The Safety, Tolerability, And Pharmacokinetics With 2-weeks Of Dosing Of Pf-06427878 In Overweight-obese, Otherwise Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02855177
Other study ID # B7871005
Secondary ID
Status Completed
Phase Phase 1
First received August 1, 2016
Last updated May 3, 2017
Start date August 24, 2016
Est. completion date April 12, 2017

Study information
Verified date May 2017
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics after 2 weeks of dosing of PF-06427878 in overweight-obese, otherwise healthy adult subjects.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date April 12, 2017
Est. primary completion date April 12, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Healthy male and/or female subjects of non childbearing potential.

- Body Mass Index (BMI) of >=25 kg/m2; and a total body weight >50 kg

- Subjects with liver fat >=6% and <=20%

Exclusion Criteria:

- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary,gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Placebo as suspension administered every 8 hours, with food
• PF-06427878
500 mg suspension administered every 8 hours, with food

Locations
Country Name City State
United States California Clinical Trials Medical Group Glendale California
United States Qps-Mra, Llc South Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Treatment Emergent Treatment-Related Adverse Events (AEs) Day -2 to Day 44
Primary Change from baseline in clinical laboratory tests Day 1 to Day 22
Primary Change from baseline in vital signs Day 0 to Day 22
Primary Change from baseline in cardiac conduction intervals assessed via 12-lead electrocardiogram Day 0 to Day 22
Secondary Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 1 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
Secondary Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 on day 1 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
Secondary Area Under the Curve for PF-06427878 during the dosing interval (AUCtau) on day 1 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
Secondary Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
Secondary Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 on day 14 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
Secondary Area Under the Curve for PF-06427878 during the dosing interval (AUCtau) on day 14 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
Secondary Plasma Decay Half-Life (t1/2) for PF-06427878 on day 14 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
Secondary Apparent Volume of Distribution (Vz/F) of PF-06427878 on day 14 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
Secondary Apparent Oral Clearance (CL/F) of PF-06427878 on day 14 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
Secondary Minimum Observed Plasma Concentration (Cmin) for PF-06427878 on day 14 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
Secondary Peak:Trough ratio of PF-06427878 on day 14 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
Secondary Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day 14 relative to day 1 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
Secondary Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day 14 relative to day 1 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose
Secondary Amount of PF-06427878 excreted in urine (Ae) on day 14 0-8 hours post dose
Secondary Percent of dose excreted in urine as PF-06427878 (Ae%) on day 14 0-8 hours post dose
Secondary Renal clearance of PF-06427878 (CLr) on day 14 0-8 hours post dose
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