A Single Oral Dose Study Of PF-06427878 In Healthy Adult Subjects
Study Details
Study Description
Brief 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 single oral doses of PF-06427878 in healthy adult subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1-PF-06427878 or placebo Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK. |
Drug: PF-06427878
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
Drug: Placebo
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
|
| Experimental: Cohort 2-PF-06427878 or placebo Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK. |
Drug: PF-06427878
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
Drug: Placebo
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
|
| Experimental: Cohort 3-PF-06427878 or placebo Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK. |
Drug: PF-06427878
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
Drug: Placebo
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
|
Outcome Measures
Primary Outcome Measures
- Assessment of adverse events (AEs). [0-48 h post dose]
- Assessment of clinical laboratory tests. [0-48 h post dose]
- Assessment of vital signs (including blood pressure and pulse rate). [0-48 h post dose]
- Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG). [0-48 h post dose]
Secondary Outcome Measures
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06427878 [0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose]
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for PF-06427878 [0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose]
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).
- Maximum Observed Plasma Concentration (Cmax) for PF-06427878 [0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose]
- Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 [0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose]
- Apparent Oral Clearance (CL/F) for PF-06427878 [0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose]
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
- Apparent Volume of Distribution (Vz/F) for PF-06427878 [0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose]
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
- Plasma Decay Half-Life (t1/2) for PF-06427878 [0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose]
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Eligibility Criteria
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
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New Haven Clinical Research Unit | New Haven | Connecticut | United States | 06511 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- B7871001