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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
A Study of Bitopertin (RO4917838) in Healthy Male Volunteers
Scientific title
Single Oral Ascending Dose Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO4917838 in Healthy Male Volunteers.
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteer 0 0
Condition category
Condition code

Study type
Description of intervention(s) / exposure
Treatment: Drugs - bitopertin
Treatment: Drugs - placebo

Experimental: Bitopertin -

Placebo Comparator: Placebo -

Treatment: Drugs: bitopertin
Single oral dose

Treatment: Drugs: placebo
Single oral dose

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Safety: Incidence of adverse events
Timepoint [1] 0 0
17 days
Secondary outcome [1] 0 0
Pharmacokinetics: Area under the concentration-time curve
Timepoint [1] 0 0
Pre-dose and 1, 2, 4, 8, 12, 24, 72, 96, 144, 168 (+/-8), 216 (+/-24), 288 (1/-48) hours post-dose
Secondary outcome [2] 0 0
Pharmacokinetics: Urine concentrations drug/metabolites
Timepoint [2] 0 0
Pre-dose and up to 72 hours post-dose

Key inclusion criteria
- Male healthy volunteer, 18 to 60 years of age inclusive

- Body mass index (BMI) 19-35 kg/m2 inclusive

- Supine blood pressure within the normal range of the center and heart rate >/= 40
provided QTcB is <450 ms

- Subjects must agree to use a barrier method of contraception (e.g. condom) for the
duration of the study and for 30 days after study completion
Minimum age
18 Years
Maximum age
60 Years
Can healthy volunteers participate?
Key exclusion criteria
- History or evidence of any clinically significant disease or disorder

- Clinically significant ECG abnormalities

- Positive for hepatitis B, hepatitis C or HIV infection

- Previous treatment with iron for iron deficiency anemia

- Regular smoker (>10 cigarettes, >3 pipefuls or >3 cigars per day)

- History of alcohol and/or drug abuse or addiction within the last 2 years before study

- Any confirmed significant allergic reactions against any drug, or multiple allergies
in the judgment of the investigator

- Participation in a clinical study with an investigational drug within the last three
months prior to screening

- Any condition or disease detected during the medical interview/physical examination
that would render the subject unsuitable for the study, place the subject at undue
risk or interfere with the ability of the subject to complete the study in the opinion
of the investigators or their designee

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people analysing the results/data
Intervention assignment
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Hoffmann-La Roche

Ethics approval
Ethics application status

Brief summary
This randomized, double-blind, placebo-controlled, dose-escalating study will evaluate the
safety, tolerability, pharmacokinetics and pharmacodynamics of bitopertin in healthy male
volunteers. Subjects will be randomized in cohorts to receive single oral doses of either
bitopertin or placebo.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Other publications