NCT01159483

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	PF-04958242	Administered as specified in the treatment arm
DRUG	Placebo	Administered as specified in the treatment arm

Timeline

• Start date: 2010-07-15
• Primary completion: 2010-10-16
• Completion: 2010-10-16
• First posted: 2010-07-09
• Last updated: 2019-12-24

Locations

1 site across 1 country: Singapore