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

NCT01238679 | Terminated Phase 1

• 1 other identifier: B1701002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (14)

• 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

Study Arms (7)

Cohort 1

EXPERIMENTAL

Participants received an oral solution of 0.03 milligrams (mg) of PF-04958242, every 12 hours for 14 days.

Drug: PF-04958242

Cohort 2

EXPERIMENTAL

Participants received an oral solution of 0.05 mg of PF-04958242, every 24 hours for 14 days.

Drug: PF-04958242

Cohort 3

EXPERIMENTAL

Participants received an oral solution of 0.10 mg of PF-04958242, every 24 hours for 14 days.

Drug: PF-04958242

Cohort 4

EXPERIMENTAL

Participants received an oral solution of 0.15 mg of PF-04958242, every 24 hours for 14 days.

Drug: PF-04958242

Cohort 5

EXPERIMENTAL

Participants received an oral solution of 0.20 mg of PF-04958242, every 24 hours for 14 days.

Drug: PF-04958242

Cohort 6

EXPERIMENTAL

Participants received an oral solution of 0.25 mg of PF-04958242, every 24 hours for 14 days.

Drug: PF-04958242

Matching Placebo

PLACEBO COMPARATOR

Participants received an oral solution of matching placebo, every 12 or 24 hours for 14 days.

Drug: Placebo

Interventions

PF-04958242 DRUG

Administered as specified in the treatment arm

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

Placebo DRUG

Administered as specified in the treatment arm

Matching Placebo

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index (BMI) of 17.5 to 30.5 kilograms per meter quared (kg/m2);
• Total body weight \>50 kilograms (kg) (110 pounds \[lbs\]);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Singapore, 188770, Singapore

Location

MeSH Terms

Interventions

PF-04958242

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2010
• First Posted: November 10, 2010
• Study Start: November 24, 2010
• Primary Completion: May 3, 2011
• Study Completion: May 3, 2011
• Last Updated: December 24, 2019

Record last verified: 2019-12

Locations

SG (1)