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Drug-drug interaction study of RO4917838

Drug-drug interaction study of Bitopertin(RO4917838) in healthy adult male volunteers

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221964
Enrollment
24
Registered
2012-11-16
Start date
2012-11-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

investigational material(s) Generic name etc : Bitopertin(RO4917838) INN of investigational material : bitopertin Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Inve

Sponsors

Chugai Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: -healthy volunteers -Body mass index (BMI) >=18.5 kg/m2 and <25.0 kg/m2 -Has not smoked for at least a year before screening or smoks < 10 cigarettes per day ,and will not smoke during the study period Etc.

Exclusion criteria

Exclusion criteria: Has been administered any of the medicines that can affect the pharmacokinetics of RO4917838 or concomitant drug to be tested for drug-drug interactions within two weeks before administration in Period I Etc.

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics, Safety Evaluate the pharmacokinetics and safety of RO4917838 and concomitant drug to be tested for drug-drug interactions when administered each other alone or in combination with both.

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026