Conditions: Healthy Adult Subjects Healthy Elderly Subjects
Keywords: Multiple Ascending Dose Study Safety and Tolerability Pharmacokinetics Pharmacodynamics Melatonin Plasma Dim Light Melatonin Onset
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 97
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: Multiple ascending doses administered in the morning to healthy adult subjects in a parallel study design arm 2: Multiple ascending doses administered in the evening to healthy adult subjects in a parallel study design arm 3: Multiple ascending doses administered to elderly subjects

Interventions: intervention 1: BIIB118 intervention 2: Melatonin
Intervention descriptions: intervention 1: 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 intervention 2: Positive control used to assess the validity of DLMO as pharmacodynamic endpoint.

Protocol document: