NCT02691702

Multiple Dose Study Of BIIB118 (PF-05251749) In Healthy Volunteers

A Phase 1, Double Blind, Sponsor Open, Randomized, Placebo And Active Comparator Controlled, Dose Escalation Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Escalating Doses Of Pf-05251749 In Healthy Adult And Elderly Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This is the first clinical trial to evaluate ascending multiple oral doses in healthy adult and healthy elderly subjects to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BIIB118

Detailed description

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

Conditions

• Healthy Adult Subjects
• Healthy Elderly Subjects

Interventions

Type	Name	Description
DRUG	BIIB118	Multiple ascending doses of BIIB118 (50 mg, 150 mg, 450 mg and 900 mg) as extemporaneously prepared solution/suspension administered once daily over 2 weeks
DRUG	Melatonin	Positive control used to assess the validity of DLMO as pharmacodynamic endpoint.

Timeline

• Start date: 2016-03-28
• Primary completion: 2017-01-12
• Completion: 2017-01-12
• First posted: 2016-02-25
• Last updated: 2021-02-17
• Results posted: 2018-10-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study