Clinical trial NCT01238679: Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PF-04958242 in Healthy Adult Volunteers
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2010-11-10
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events and Serious Adverse Events
timeFrame: Baseline up to Day 23
measure: Maximum Plasma Drug Concentration (Cmax) for Single Dose
timeFrame: Day 1 and at multiple time points up to Day 17
measure: Time to Reach Maximum Plasma Concentration (Tmax) for Single Dose
timeFrame: Day 1 and at multiple time points up to Day 17
measure: Area Under the Concentration Time-curve During a Dosage Interval (AUCτ) for Single Dose
timeFrame: Day 1 and at multiple time points up to Day 17
measure: Maximum Observed Plasma Concentration (Cmax) for Steady State
timeFrame: Day 1 and at multiple time points up to Day 17
measure: Area Under the Plasma Drug Concentration-Time Curve During a Dosage Interval (AUCτ) for Steady State
timeFrame: Day 1 and at multiple time points up to Day 17
measure: Apparent Total Clearance of the Drug from Plasma (CL/F) for Steady State
timeFrame: Day 1 and at multiple time points up to Day 17
measure: Apparent Volume of Distribution During Terminal Phase (Vz/F) for Steady State
timeFrame: Day 1 and at multiple time points up to Day 17
measure: Elimination Half-Life (t1/2) for Steady State
timeFrame: Day 1 and at multiple time points up to Day 17
measure: Accumulation Ratio (AUC(τ,ss)/AUC(τ,sd)) for Steady State
timeFrame: Day 1 and at multiple time points up to Day 17
measure: Percent of Dose Eliminated in Urine Unchanged (Ae%)
timeFrame: Day 14
measure: Amount of PF-04958242 Eliminated in Urine Unchanged (Ae)
timeFrame: Day 14
measure: Renal Clearance (CLr)
timeFrame: Day 14
measure: Time to Reach Maximum Plasma Concentration (Tmax) for Steady State
timeFrame: Day 1 and at multiple time points up to Day 17
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: