First-in-Human Study of PF-04958242 in Healthy Volunteers

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

The primary objective of this study will evaluate the safety and tolerability of single, escalating doses of PF-04958242 administered orally to healthy adult participants. This study will also evaluate the plasma pharmacokinetics (PK) of single doses of PF-04958242 after single escalating doses of PF-04958242 administered orally to healthy adult participants.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: PF-04958242; Drug: Placebo

Detailed Description

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

• Study Type: Interventional
• Enrollment (Actual): 24
• 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: Yes
• 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: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A; Period 1: Participants received 0.01 milligrams (mg) of PF-04958242 or matching placebo, once, orally. Period 2: Participants received 0.03 mg of PF-04958242 or matching placebo, once, orally. Period 3: Participants received 0.1 mg of PF-04958242 or matching placebo, once, orally.	Drug: PF-04958242; Administered as specified in the treatment arm; Drug: Placebo; Administered as specified in the treatment arm
Experimental: Cohort B; Period 1: Participants received 0.3 mg of PF-04958242 or matching placebo, once, orally (fasted). Period 2: Participants received 0.6 mg of PF-04958242 or matching placebo, once, orally. Period 3: Participants received 1.0 mg of PF-04958242 or matching placebo, once, orally (fed).	Drug: PF-04958242; Administered as specified in the treatment arm; 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	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 to Day 4
Maximum Observed Plasma Concentration (Cmax)		Day 1 and at multiple time points up to Day 4
Time to Reach Cmax (Tmax)		Day 1 and at multiple time points up to Day 4
Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf)		Day 1 and at multiple time points up to Day 4
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)		Day 1 and at multiple time points up to Day 4
Apparent Total Plasma Clearance (CL/F)		Day 1 and at multiple time points up to Day 4
Apparent Terminal Elimination Half-life (t½)		Day 1 and at multiple time points up to Day 4
Area Under the Plasma Drug Concentration-Time Curve up to the Last Quantifiable Time-Point (AUC0-last)		Day 1 and at multiple time points up to Day 4

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2010
• Primary Completion (Actual): October 16, 2010
• Study Completion (Actual): October 16, 2010

Study Registration Dates

• First Submitted: July 7, 2010
• First Submitted That Met QC Criteria: July 7, 2010
• First Posted (Estimate): July 9, 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: B1701001