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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01159483
• Other study ID #: B1701001
• Status: Completed
• Phase: Phase 1
• Start date: July 15, 2010
• Est. completion date: October 16, 2010

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 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 16, 2010
• Est. primary completion date: October 16, 2010
• 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 Volunteer

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	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
Primary	Maximum Observed Plasma Concentration (Cmax)		Day 1 and at multiple time points up to Day 4
Primary	Time to Reach Cmax (Tmax)		Day 1 and at multiple time points up to Day 4
Primary	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
Primary	Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)		Day 1 and at multiple time points up to Day 4
Primary	Apparent Total Plasma Clearance (CL/F)		Day 1 and at multiple time points up to Day 4
Primary	Apparent Terminal Elimination Half-life (t½)		Day 1 and at multiple time points up to Day 4
Primary	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