A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of RO6953958 in Healthy Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

July 15, 2020

Primary Completion Date

February 6, 2022

Study Completion Date

February 6, 2022

Conditions
Autistic DisorderAutism Spectrum DisorderChild Development Disorders, PervasiveMental DisordersNeurodevelopmental Disorders
Interventions
DRUG

RO6953958

"Part 1: RO6953958 will be administered in an adaptive manner. The starting dose is planned to be 5 milligrams (mg).~Part 2: The starting dose is planned to be 45 mg.~Part 3: RO6953958 will be administered QD following a standardized breakfast on Day 3 to Day 14 at the maximum dose QD that was tested in the ongoing Part 2 (MAD)."

DRUG

Placebo

"Part 1: A placebo will be administered in an adaptive manner. The starting dose is planned to be 5 mg.~Part 2: The starting dose is planned to be 45 mg."

DRUG

Midazolam

Midazolam will be administered as single intervenous (IV) bolus injection of 100 micrograms (ug) on Day 1 and Day 13, and as single oral dose of 300 ug on Day 2 and Day 14.

Trial Locations (1)

NW10 7EW

Hammersmith Medicines Research; Central Middlesex Hospital, London

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT04475848 - A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of RO6953958 in Healthy Participants | Biotech Hunter | Biotech Hunter