The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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 placebo-controlled, randomized, observer-blind, dose-ascending study will investigate
the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses
of RO5271983 in healthy volunteers. Healthy volunteers will be randomized to receive either a
single oral dose of RO5271983 or placebo in the SAD part or multiple oral doses of RO5271983
or placebo in the MAD part. The anticipated time on study treatment is approximately 14 weeks
for the SAD part and up to 8 weeks for the MAD part.
Trial website
https://clinicaltrials.gov/show/NCT01209221
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

Summary results
Other publications