Hypercholesterolemia
Conditions
Keywords
Healthy subjects, Single Ascending Dose, Hyperlipidemia, Dyslipidemia
Brief summary
The current study is the first clinical trial proposed with PF-06815345. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single oral doses of PF-06815345 to healthy adult subjects.
Interventions
DRUGPF-06815345
PF-06815345 will be administered as a liquid dosage formulation
OTHERPlacebo
Placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males and female of non-childbearing potential; * Age of 18-55, inclusive; * Body Mass Index 17.5-34.9 kg/m2, inclusive; * Body weight \>50 kg; * Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose.
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) | Baseline (Day 0) up to 28 days after last dose of study medication | Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06815345 | 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose | AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity). |
| Maximum Observed Plasma Concentration (Cmax) for PF-06815345 | 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose | Maximum Observed Plasma Concentration (Cmax) |
| Time to Reach Maximum Observed Concentration for PF-06815345 | 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose | Time to Reach Maximum Observed Plasma Concentration (Tmax) |
| Plasma Decay Half-Life (t1/2) for PF-06815345 | 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose | Plasma Decay Half-Life (t1/2) |
| Apparent Oral Clearance (CL/F) for PF-06815345 | 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 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. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06815345 | 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 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 Last Quantifiable Concentration (AUClast) for the metabolite (PF-06811701) | 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 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- infinity)] for metabolite (PF-06811701) | 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose | AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity). |
| Maximum Observed Plasma Concentration (Cmax) for metabolite (PF-06811701) | 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose | Maximum Observed Plasma Concentration (Cmax) |
| Time to Reach Maximum Observed Concentration for metabolite (PF-06811701) | 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose | Time to Reach Maximum Observed Plasma Concentration (Tmax) |
| Plasma Decay Half-Life (t1/2) for metabolite (PF-06811701) | 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose | Plasma Decay Half-Life (t1/2) |
| Apparent Volume of Distribution (Vz/F) for PF-06815345 | 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 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. |
Countries
Belgium
Outcome results
None listed