At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 97 enrolled
Drug / intervention
BIIB118 +1 moredrug
Likely dose
BIIB118 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating BIIB118 and Melatonin for Healthy Adult Subjects and Healthy Elderly Subjects. Completed, enrolled 97 participants across 2 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Adult Subjects, Healthy Elderly Subjects
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 2016
Enrollment StartMar 2016
Primary CompletionJan 2017
TodayJul 2026
First PostedFeb 25, 2016
Enrollment StartMar 28, 2016
Primary CompletionJan 12, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.4 years ago
Interventions
BIIB118drug
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
Melatonindrug
Positive control used to assess the validity of DLMO as pharmacodynamic endpoint.