Status:
COMPLETED
First-in-Human Study of PF-04958242 in Healthy Volunteers
Lead Sponsor:
Biogen
Conditions:
Healthy Volunteer
Eligibility:
All Genders
21-55 years
Phase:
PHASE1
Brief 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 evaluat...
Detailed Description
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
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 :
July 15 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01159483
Start Date
July 15 2010
End Date
October 16 2010
Last Update
December 24 2019
Active Locations (1)
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1
Research Site
Singapore, Singapore, 188770