Clinical trial NCT02654899: Single Dose Study of PF-06815345 in Healthy Subjects
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06815345, As Well As Characterize The Pharmacokinetics Of Two Formulations And Effect Of Food On Pharmacokinetics Of One Formulation Of Pf-06815345 Administered To Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hypercholesterolemia
Keywords: Healthy subjects
Single Ascending Dose
Hyperlipidemia
Dyslipidemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-01-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs)
timeFrame: Baseline (Day 0) up to 28 days after last dose of study medication
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06815345
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06815345
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
measure: Maximum Observed Plasma Concentration (Cmax) for PF-06815345
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
measure: Time to Reach Maximum Observed Concentration for PF-06815345
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
measure: Plasma Decay Half-Life (t1/2) for PF-06815345
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
measure: Apparent Oral Clearance (CL/F) for PF-06815345
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
measure: Apparent Volume of Distribution (Vz/F) for PF-06815345
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for the metabolite (PF-06811701)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for metabolite (PF-06811701)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
measure: Maximum Observed Plasma Concentration (Cmax) for metabolite (PF-06811701)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
measure: Time to Reach Maximum Observed Concentration for metabolite (PF-06811701)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
measure: Plasma Decay Half-Life (t1/2) for metabolite (PF-06811701)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: