Single Dose Study of PF-06815345 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Part 1_Cohort 1_Active;

Single ascending dose of PF-06815345

Group Type EXPERIMENTAL

PF-06815345

Intervention Type DRUG

PF-06815345 will be administered as a liquid dosage formulation

Part 1_Cohort 1_Placebo;

Single dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Part 1_Cohort 2_Active

Single ascending dose of PF-06815345

Group Type EXPERIMENTAL

PF-06815345

Intervention Type DRUG

PF-06815345 will be administered as a liquid dosage formulation

Part 1_Cohort 2_Placebo

Single dose of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Part 2

Single dose of solid dosage formulation (test) versus liquid dosage formulation (reference) of PF-06815345

Group Type EXPERIMENTAL

PF-06815345

Intervention Type DRUG

PF-06815345 will be administered as either solid dosage formulation or liquid dosage formulation

Interventions

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PF-06815345

PF-06815345 will be administered as a liquid dosage formulation

Intervention Type DRUG

Placebo

Intervention Type OTHER

PF-06815345

PF-06815345 will be administered as either solid dosage formulation or liquid dosage formulation

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes