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

NCT01209221 | Completed Phase 1

• 1 other identifier: NP25342
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (6)

• Single ascending dose (SAD): Pharmacokinetics (plasma concentration) of RO5271983

  up to 240 hours

• Single ascending dose (SAD): Safety (incidence of adverse events)

  14 weeks

• Single ascending dose (SAD): Tolerability (e.g. vital signs)

  14 weeks

• Multiple ascending doses (MAD): Pharmacokinetics (plasma concentration) of RO5271983

  17 days

• Multiple ascending doses (MAD): Safety (incidence of adverse events)

  8 weeks

• Multiple ascending doses (MAD): Tolerability (e.g. vital signs)

  8 weeks

Secondary Outcomes (3)

• Effect of food on pharmacokinetics of RO5271983

  up to 240 hours

• Single ascending dose (SAD): Pharmacodynamics (blood analysis) of RO5271983

  72 hours

• Multiple ascending doses (MAD): Pharmacodynamics (blood analysis) of RO5271983

  14 days

Study Arms (4)

1

EXPERIMENTAL

Drug: RO5271983 - SAD

2

EXPERIMENTAL

Drug: RO5271983 - MAD

3

PLACEBO COMPARATOR

Drug: Placebo - SAD

4

PLACEBO COMPARATOR

Drug: Placebo - MAD

Interventions

Placebo - MAD DRUG

Once or twice daily doses of matching placebo to RO5271983 for 14 days

4

Placebo - SAD DRUG

Single dose of matching placebo to RO5271983 for up to 3 periods

3

RO5271983 - MAD DRUG

Once or twice daily doses of RO5271983 for 14 days

2

RO5271983 - SAD DRUG

Single dose of RO5271983 at each period (for up to 3 periods)

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Christchurch, 8011, New Zealand

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2010
• First Posted: September 27, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

NZ (1)