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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01636492




Registration number
NCT01636492
Ethics application status
Date submitted
6/07/2012
Date registered
10/07/2012
Date last updated
2/11/2016

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
BP19292
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

Intervention/exposure
Study type
Interventional
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

Outcomes
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

Eligibility
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
Sex
Males
Can healthy volunteers participate?
Yes
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
start

- 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
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2006
Sample size
Target
Accrual to date
Final
71
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

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

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/ct2/show/NCT01636492
Trial related presentations / publications
Public notes

Contacts
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