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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01209221




Registration number
NCT01209221
Ethics application status
Date submitted
24/09/2010
Date registered
27/09/2010
Date last updated
2/11/2016

Titles & IDs
Public title
A Single Ascending And Multiple Ascending Dose Study of RO5271983 in Healthy Volunteers
Scientific title
A Phase 1 Placebo-controlled, Randomized, Observer-blind Combined Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5271983 in Healthy Subjects.
Secondary ID [1] 0 0
NP25342
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 - Placebo - MAD
Treatment: Drugs - Placebo - SAD
Treatment: Drugs - RO5271983 - MAD
Treatment: Drugs - RO5271983 - SAD

Experimental: 1 -

Experimental: 2 -

Placebo comparator: 3 -

Placebo comparator: 4 -


Treatment: Drugs: Placebo - MAD
Once or twice daily doses of matching placebo to RO5271983 for 14 days

Treatment: Drugs: Placebo - SAD
Single dose of matching placebo to RO5271983 for up to 3 periods

Treatment: Drugs: RO5271983 - MAD
Once or twice daily doses of RO5271983 for 14 days

Treatment: Drugs: RO5271983 - SAD
Single dose of RO5271983 at each period (for up to 3 periods)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Single ascending dose (SAD): Pharmacokinetics (plasma concentration) of RO5271983
Timepoint [1] 0 0
up to 240 hours
Primary outcome [2] 0 0
Single ascending dose (SAD): Safety (incidence of adverse events)
Timepoint [2] 0 0
14 weeks
Primary outcome [3] 0 0
Single ascending dose (SAD): Tolerability (e.g. vital signs)
Timepoint [3] 0 0
14 weeks
Primary outcome [4] 0 0
Multiple ascending doses (MAD): Pharmacokinetics (plasma concentration) of RO5271983
Timepoint [4] 0 0
17 days
Primary outcome [5] 0 0
Multiple ascending doses (MAD): Safety (incidence of adverse events)
Timepoint [5] 0 0
8 weeks
Primary outcome [6] 0 0
Multiple ascending doses (MAD): Tolerability (e.g. vital signs)
Timepoint [6] 0 0
8 weeks
Secondary outcome [1] 0 0
Effect of food on pharmacokinetics of RO5271983
Timepoint [1] 0 0
up to 240 hours
Secondary outcome [2] 0 0
Single ascending dose (SAD): Pharmacodynamics (blood analysis) of RO5271983
Timepoint [2] 0 0
72 hours
Secondary outcome [3] 0 0
Multiple ascending doses (MAD): Pharmacodynamics (blood analysis) of RO5271983
Timepoint [3] 0 0
14 days

Eligibility
Key inclusion criteria
* Healthy volunteers, 18-65 years of age
* Body Mass Index (BMI) between 18 and 32 kg/m2, inclusive
* In the SAD, females subjects must be surgically sterile or post-menopausal for the past year; in the MAD females may be of child-bearing potential but must use 2 methods of highly effective contraception
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* A history of clinically relevant cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurological, psychiatric, allergic or skin disease
* Clinical significant abnormalities in laboratory test results
* Symptoms of an infectious disease including upper respiratory tract infection within one month of study start or a history of recurrent infections
* Smokers of >5 cigarettes/day within 3 months prior to admission and unable to stop smoking during study

Study design
Purpose of the study
Treatment
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


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
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
82
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01209221