Phase
Condition
Birth Defects
Tic Disorders
Asperger's Disorder
Treatment
RO6953958
Placebo
Midazolam
Clinical Study ID
Ages 18-55 Male Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Body mass index (BMI) within 18 to 31 kg/m2
During treatment and for at least 14 days after the last dose to remain abstinent
Refrain from donating sperm for at least 14 days after last dose
Part 2 (MAD) only - Participants must be prepared to collect a sleep log and wear anactigraphy device the week before participation in the study. Participants must alsohave scored 5 or less on the Pittsburgh Sleep Quality Index (PSQI), less than 13 onthe Epworth sleepiness scale (ESS), and not be considered an extreme morning orevening type according to the morningness-eveningness questionnaire (MEQ) atscreening to be eligible.
Exclusion
Exclusion Criteria:
History or evidence of any medical condition potentially altering the absorption,metabolism, or elimination of drugs
History of any clinically significant gastrointestinal, renal, hepatic,bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological,hematological, or allergic disease, sleep disorders (Part 2 [MAD] only), unexplainedsyncope (within 12 months prior to screening), metabolic disorder, cancer, orcirrhosis
Use of any psychoactive medication, or medications known to have effects on centralnervous system (CNS), or blood flow
History of convulsions
History of clinically significant hypersensitivity (e.g., drugs, excipients) orallergic reactions
Abnormal blood pressure (BP) and pulse rate
Presence of orthostatic hypotension
History or presence of clinically significant ECG abnormalities or cardiovasculardisease
Current or chronic history of liver disease or known hepatic or biliaryabnormalities
Known active or any major episode of infection within 4 weeks prior to the start ofdrug administration
Participants who test positive for acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Have used or intend to use over-the-counter (OTC) or prescription medicationincluding herbal medications within 30 days prior to dosing
Positive test for drugs, abuse of alcohol, human immunodeficiency virus (HIV),hepatitis B or hepatitis C virus (HCV), presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test
Inability or unwillingness to fully consume standardized breakfast at Day 1
Part 2 (MAD) only - Participants who have issues sleeping or participants who havetravelled across 2 or more time zones in the past month.
Part 2 (MAD) only - Participants who cannot produce sufficient saliva for studyassessments
Participants who have donated more than 500 mL of blood or blood products or hadsignificant blood loss within 3 months prior to screening
Have a history of clinically significant back pain, back pathology, and/or backinjury that may predispose to complications from, or technical difficulty with,lumbar puncture
Complications that would lead to difficulty in obtaining a lumbar puncture
Part 3 (DDI) only - History of hypersensitivity to benzodiazepines (includingmidazolam) or its formulation ingredients
Study Design
Connect with a study center
Hammersmith Medicines Research; Central Middlesex Hospital
London, NW10 7EW
United KingdomSite Not Available

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