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

A Phase I, Randomized, Subject and Investigator-Blind, Sponsor Open, Multiple Escalating Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PF-04958242 in Healthy Adult Volunteers

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.

Study Overview

• Status: Terminated
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: PF-04958242; Drug: Placebo

Detailed Description

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
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 188770
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Participants received an oral solution of 0.03 milligrams (mg) of PF-04958242, every 12 hours for 14 days.	Drug: PF-04958242; Administered as specified in the treatment arm
Experimental: Cohort 2; Participants received an oral solution of 0.05 mg of PF-04958242, every 24 hours for 14 days.	Drug: PF-04958242; Administered as specified in the treatment arm
Experimental: Cohort 3; Participants received an oral solution of 0.10 mg of PF-04958242, every 24 hours for 14 days.	Drug: PF-04958242; Administered as specified in the treatment arm
Experimental: Cohort 4; Participants received an oral solution of 0.15 mg of PF-04958242, every 24 hours for 14 days.	Drug: PF-04958242; Administered as specified in the treatment arm
Experimental: Cohort 5; Participants received an oral solution of 0.20 mg of PF-04958242, every 24 hours for 14 days.	Drug: PF-04958242; Administered as specified in the treatment arm
Experimental: Cohort 6; Participants received an oral solution of 0.25 mg of PF-04958242, every 24 hours for 14 days.	Drug: PF-04958242; Administered as specified in the treatment arm
Placebo Comparator: Matching Placebo; Participants received an oral solution of matching placebo, every 12 or 24 hours for 14 days.	Drug: Placebo; Administered as specified in the treatment arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline up to Day 23
Maximum Plasma Drug Concentration (Cmax) for Single Dose		Day 1 and at multiple time points up to Day 17
Time to Reach Maximum Plasma Concentration (Tmax) for Single Dose		Day 1 and at multiple time points up to Day 17
Area Under the Concentration Time-curve During a Dosage Interval (AUCτ) for Single Dose		Day 1 and at multiple time points up to Day 17
Maximum Observed Plasma Concentration (Cmax) for Steady State		Day 1 and at multiple time points up to Day 17
Area Under the Plasma Drug Concentration-Time Curve During a Dosage Interval (AUCτ) for Steady State		Day 1 and at multiple time points up to Day 17
Apparent Total Clearance of the Drug from Plasma (CL/F) for Steady State		Day 1 and at multiple time points up to Day 17
Apparent Volume of Distribution During Terminal Phase (Vz/F) for Steady State		Day 1 and at multiple time points up to Day 17
Elimination Half-Life (t1/2) for Steady State		Day 1 and at multiple time points up to Day 17
Accumulation Ratio (AUC(τ,ss)/AUC(τ,sd)) for Steady State		Day 1 and at multiple time points up to Day 17
Percent of Dose Eliminated in Urine Unchanged (Ae%)		Day 14
Amount of PF-04958242 Eliminated in Urine Unchanged (Ae)		Day 14
Renal Clearance (CLr)		Day 14
Time to Reach Maximum Plasma Concentration (Tmax) for Steady State		Day 1 and at multiple time points up to Day 17

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2010
• Primary Completion (Actual): May 3, 2011
• Study Completion (Actual): May 3, 2011

Study Registration Dates

• First Submitted: November 2, 2010
• First Submitted That Met QC Criteria: November 9, 2010
• First Posted (Estimate): November 10, 2010

Study Record Updates

• Last Update Posted (Actual): December 24, 2019
• Last Update Submitted That Met QC Criteria: December 20, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: B1701002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No