NCT02443740

Safety, Tolerability and Pharmacokinetics of BIIB118 (PF-05251749)

A Phase 1, Randomized, Double Blind, Placebo Controlled Study To Investigate The Safety, Tolerability, Pharmacokinetics And Relative Bioavailability Of Single Escalating Oral Doses Of Pf-05251749 In Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a First in human (FIH) single ascending dose study to evaluate the safety, tolerability and pharmacokinetics (PKs) of BIIB118 following single oral doses in healthy human subjects

Detailed description

This study was previously posted by Pfizer. In March, 2020, sponsorship of the trial was transferred to Biogen.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BIIB118	Single ascending doses of BIIB118 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 3 mg, 30 mg, 200 mg, 800 mg and placebo
DRUG	BIIB118	Single ascending doses of BIIB118 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 10 mg, 100 mg, 400 mg, and placebo
DRUG	BIIB118	Single dose (Maximum Tolerated Dose) of BIIB118 as extemporaneously prepared solution/suspension

Timeline

• Start date: 2015-05-31
• Primary completion: 2015-10-31
• Completion: 2015-10-31
• First posted: 2015-05-14
• Last updated: 2021-02-17
• Results posted: 2018-05-17

Locations

1 site across 1 country: United States