A Single Ascending And Multiple Ascending Dose Study of RO5271983 in Healthy Volunteers

Healthy Volunteer Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01209221
• Other study ID #: NP25342
• Status: Completed
• Phase: Phase 1
• First received: September 24, 2010
• Last updated: November 1, 2016
• Start date: September 2010
• Est. completion date: October 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Health and Disability Ethics Committees
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Placebo - MAD
Once or twice daily doses of matching placebo to RO5271983 for 14 days
• Placebo - SAD
Single dose of matching placebo to RO5271983 for up to 3 periods
• RO5271983 - MAD
Once or twice daily doses of RO5271983 for 14 days
• RO5271983 - SAD
Single dose of RO5271983 at each period (for up to 3 periods)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single ascending dose (SAD): Pharmacokinetics (plasma concentration) of RO5271983		up to 240 hours	No
Primary	Single ascending dose (SAD): Safety (incidence of adverse events)		14 weeks	No
Primary	Single ascending dose (SAD): Tolerability (e.g. vital signs)		14 weeks	No
Primary	Multiple ascending doses (MAD): Pharmacokinetics (plasma concentration) of RO5271983		17 days	No
Primary	Multiple ascending doses (MAD): Safety (incidence of adverse events)		8 weeks	No
Primary	Multiple ascending doses (MAD): Tolerability (e.g. vital signs)		8 weeks	No
Secondary	Effect of food on pharmacokinetics of RO5271983		up to 240 hours	No
Secondary	Single ascending dose (SAD): Pharmacodynamics (blood analysis) of RO5271983		72 hours	No
Secondary	Multiple ascending doses (MAD): Pharmacodynamics (blood analysis) of RO5271983		14 days	No