A Multiple Oral Doses Study Of PF-06427878 In Healthy Adult Subjects

Healthy Subjects Clinical Trial

Official title:

A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Multiple Escalating Oral Doses Of Pf-06427878 Co Administered With And Without Food In Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391623
• Other study ID #: B7871002
• Secondary ID: 2015-000130-29
• Status: Completed
• Phase: Phase 1
• First received: March 12, 2015
• Last updated: March 1, 2016
• Start date: March 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPUnited States: Food and Drug Administration
• 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 of multiple oral doses of PF-06427878 in healthy adult subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• 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 17.5 to 35.4 kg/m2; and a total body weight >50 kg

• Subjects with fasting TG level of >=90 mg/dL and <=500 mg/dL following an overnight fast

• Subjects with low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL following an overnight fast

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

Allocation: Randomized, Endpoint Classification: Safety Study, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• PF-06427878
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
• Placebo
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
• PF-06427878
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
• Placebo
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of adverse events (AEs).		0-25 days	Yes
Primary	Assessment of clinical laboratory tests.		0-25 days	Yes
Primary	Assessment of vital signs (including blood pressure and pulse rate).		0-25 days	Yes
Primary	Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).		0-25 days	Yes
Secondary	Maximum Observed Plasma Concentration (Cmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1		0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose	No
Secondary	Maximum Observed Plasma Concentration (Cmax) for PF-06427878during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12		0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose	No
Secondary	Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14		0, 1, 2, 3, 4, 6, 8, 12 hours post dose	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1		0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12		0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14		0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose	No
Secondary	Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1		0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose	No
Secondary	Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12		0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose	No
Secondary	Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14		0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose	No
Secondary	Plasma Decay Half-Life (t1/2) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14		0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose	No
Secondary	Apparent Volume of Distribution (Vz/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14		0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose	No
Secondary	Apparent Oral Clearance (CL/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14		0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose	No
Secondary	Minimum Observed Plasma Concentration (Cmin) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14		0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose	No
Secondary	Peak:Trough ratio of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14		0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose	No
Secondary	Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1		0, 1, 2, 3, 4, 6, 8, 12 hours post dose	No
Secondary	Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD		0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose	No
Secondary	Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day14 relative to day 1		0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose	No
Secondary	Amount of PF-06427878 excreted in urine (Ae) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14		0- tau hours post dose	No
Secondary	Percent of dose excreted in urine as PF-06427878 (Ae%) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14		0- tau hours post dose	No
Secondary	Renal clearance of PF-06427878 (CLr) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14		0- tau hours post dose	No

External Links

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