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Register:	ClinicalTrials.gov
Last refreshed on:	11 April 2016
Main ID:	NCT02391623
Date of registration:	12/03/2015
Prospective Registration:	No
Primary sponsor:	Pfizer
Public title:	A Multiple Oral Doses Study Of PF-06427878 In Healthy Adult Subjects
Scientific 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
Date of first enrolment:	March 2015
Target sample size:	40
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02391623
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Safety Study, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Phase:	Phase 1

Countries of recruitment
Belgium

Contacts

Name:	Pfizer CT.gov Call Center
Address:
Telephone:
Email:
Affiliation:	Pfizer

Key inclusion & exclusion criteria

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).

Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Subjects

Intervention(s)

Drug: Placebo

Drug: PF-06427878

Primary Outcome(s)

Assessment of clinical laboratory tests. [Time Frame: 0-25 days]

Assessment of adverse events (AEs). [Time Frame: 0-25 days]

Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG). [Time Frame: 0-25 days]

Assessment of vital signs (including blood pressure and pulse rate). [Time Frame: 0-25 days]

Secondary Outcome(s)

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 [Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose]

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 [Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose]

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 [Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose]

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 [Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose]

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 [Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose]

Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day14 relative to day 1 [Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose]

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 [Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose]

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 [Time Frame: 0- tau hours post dose]

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 [Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose]

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 [Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose]

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 [Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose]

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 [Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose]

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 [Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose]

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 [Time Frame: 0- tau hours post dose]

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 [Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose]

Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14 [Time Frame: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose]

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 [Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose]

Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 [Time Frame: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose]

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 [Time Frame: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose]

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 [Time Frame: 0- tau hours post dose]

Secondary ID(s)

2015-000130-29

B7871002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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