Single Dose Study of PF-06815345 in Healthy Subjects

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Hypercholesterolemia

Treatments: Drug: PF-06815345; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02654899

C0281001

2015-003935-36 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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25 participants in 5 patient groups, including a placebo group

Part 1_Cohort 1_Active;

Experimental group

Description:

Single ascending dose of PF-06815345

Treatment:

Drug: PF-06815345

Drug: PF-06815345

Part 1_Cohort 1_Placebo;

Placebo Comparator group

Description:

Single dose of placebo

Treatment:

Other: Placebo

Part 1_Cohort 2_Active

Experimental group

Description:

Single ascending dose of PF-06815345

Treatment:

Drug: PF-06815345

Drug: PF-06815345

Part 1_Cohort 2_Placebo

Placebo Comparator group

Description:

Single dose of placebo

Treatment:

Other: Placebo

Part 2

Experimental group

Description:

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

Treatment:

Drug: PF-06815345

Drug: PF-06815345