Status:
TERMINATED
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PF-04958242 in Healthy Adult Volunteers
Lead Sponsor:
Biogen
Conditions:
Healthy Volunteers
Eligibility:
All Genders
21-55 years
Phase:
PHASE1
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 p...
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 pro...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
November 24 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01238679
Start Date
November 24 2010
End Date
May 3 2011
Last Update
December 24 2019
Active Locations (1)
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1
Research Site
Singapore, Singapore, 188770