Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PF-04958242 in Healthy Adult Volunteers

Phase 1TerminatedNCT01238679

Biogen20 enrolled

Overview

The primary objective of this study evaluates the safety and tolerability of multiple, escalating doses of PF-04958242 administered orally to healthy adult participants.This study also evaluates the plasma and urine multiple dose pharmacokinetics (PK) of PF-04958242.

A decision was made to terminate the B1701002 study so that emerging data from the study and from a preclinical study in rats could be further examined and incorporated into a new study design and protocol. This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

PF-04958242DRUG

Administered as specified in the treatment arm

PlaceboDRUG

Administered as specified in the treatment arm

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Key Inclusion Criteria: * Body Mass Index (BMI) of 17.5 to 30.5 kilograms per meter quared (kg/m2); * Total body weight \>50 kilograms (kg) (110 pounds \[lbs\]); Key Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing); * Positive urine drug screen; * Pregnant or nursing females, and females of child bearing potential; * Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Locations (1)

Research Site

Singapore, Singapore

Outcomes

Primary Outcomes

Number of Participants Experiencing Adverse Events and Serious Adverse Events

An adverse event is any untoward medical occurrence in a clinical investigation subject administered a product or medical device. A serious adverse event or serious adverse drug reaction is any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.

Time frame: Baseline up to Day 23

Maximum Plasma Drug Concentration (Cmax) for Single Dose