Multiple Ascending Dose and DDI Study

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: atorvastatin; Drug: Placebo; Drug: PF-06835919

Study type: Interventional

Funder types: Industry

Identifiers

NCT03031119

C1061002

2016-004649-10 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

PF-06835919

Experimental group

Description:

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.

Treatment:

Drug: PF-06835919

Drug: atorvastatin

atorvastatin

Experimental group

Description:

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.

Treatment:

Drug: PF-06835919

Drug: atorvastatin