Multiple Ascending Dose and DDI Study

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-07-31

Brief Summary

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Part A will investigate the safety, tolerability, PK and PD of PF-06835919 administered for 14 days in a multiple ascending dose design. Part B will assess the effect of PF-06835919 co-administration at low and high doses on the PK of atorvastatin in a single cohort.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Tablets administered once or twice daily, with food, in Part A for 14 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablets administered once or twice daily, with food, in Part A.

PF-06835919

Tablets administered once or twice daily, with food, in Part A for 14 days. Tablets administered once or twice daily, for 4 days at a low dose and for 4 days at a higher dose, with food and atorvastatin in Part B.

Group Type EXPERIMENTAL

PF-06835919

Intervention Type DRUG

Tablets administered once or twice daily, with food, in Part A. Tablets administered once or twice daily, with food and atorvastatin in Part B.

atorvastatin

Intervention Type DRUG

In Part B, tablets administered once or twice daily, with food, with and without PF-06835919.

atorvastatin

In Part B, tablets administered once or twice daily, with food, with and without a low dose of PF-06835919 for 4 days and a higher dose of PF-06835919 for 4 days.

Group Type EXPERIMENTAL

PF-06835919

Intervention Type DRUG

Tablets administered once or twice daily, with food, in Part A. Tablets administered once or twice daily, with food and atorvastatin in Part B.

atorvastatin

Intervention Type DRUG

In Part B, tablets administered once or twice daily, with food, with and without PF-06835919.

Interventions

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Placebo

Tablets administered once or twice daily, with food, in Part A.

Intervention Type DRUG

PF-06835919

Tablets administered once or twice daily, with food, in Part A. Tablets administered once or twice daily, with food and atorvastatin in Part B.

Intervention Type DRUG

atorvastatin

In Part B, tablets administered once or twice daily, with food, with and without PF-06835919.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and females (nonchildbearing potential)
* 18 to 55 years old
* Body Mass Index 17.5 to 30.5

Exclusion Criteria

* Known hereditary fructose intolerance or fructose malabsorption disorder (Part A)
* Statin intolerance (Part B)
* Unable to consume high fructose syrup-containing beverage with each meal while in the unit (Part A)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes