Conditions: Healthy
Keywords: First in human Single Ascending Dose Study Safety and Tolerability Pharmacokinetics Plasma Cerebrospinal Fluid
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 32
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: Single ascending doses of BIIB118 administered to healthy volunteers in a cross over study design arm 2: Single ascending doses of BIIB118 administered to healthy volunteers in a cross over study design arm 3: Single maximum dose from Part A of BIIB118 administered to healthy volunteers to assess the PK of BIIB118 in CSF

Interventions: intervention 1: BIIB118 intervention 2: BIIB118 intervention 3: BIIB118
Intervention descriptions: intervention 1: 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 intervention 2: 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 intervention 3: Single dose (Maximum Tolerated Dose) of BIIB118 as extemporaneously prepared solution/suspension

Protocol document: