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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01238679
• Other study ID #: B1701002
• Status: Terminated
• Phase: Phase 1
• Start date: November 24, 2010
• Est. completion date: May 3, 2011

Study information

• Verified date: December 2019
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: May 3, 2011
• Est. primary completion date: May 3, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• PF-04958242
Administered as specified in the treatment arm
• Placebo
Administered as specified in the treatment arm

Locations

Country	Name	City	State
Singapore	Research Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Singapore, 

Outcome

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