A Pharmacodynamic and Pharmacokinetic Study of RO5508887 in Healthy Volunteers

Healthy Volunteer Clinical Trial

Official title:

A Single-Center, Randomized, Investigator/Subject-Blind, Single Dose, Placebo-Controlled, Parallel Group Study to Investigate the Pharmacodynamic and Pharmacokinetic Behavior of RO5508887 in Plasma and Cerebral Spinal Fluid Following Oral Administration in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01592331
• Other study ID #: WP27959
• Status: Completed
• Phase: Phase 1
• First received: April 19, 2012
• Last updated: November 1, 2016
• Start date: May 2012
• Est. completion date: October 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This randomized, double-blind, placebo-controlled, parallel group study will evaluate the pharmacodynamics and pharmacokinetics of RO5508887 in healthy volunteers.

Subjects will be randomized in cohorts to receive single oral doses of either RO5508887 or placebo. In-unit period is 6 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy male subjects, 18 to 65 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination

• Body mass index (BMI) 18 to 30 kg/m2 inclusive

• Must agree to use a barrier method of contraception during the treatment period and for at least 30 days after the last dose of study drug

• Donation of blood over 500 mL within 6 weeks before drug administration

Exclusion Criteria:

• Concomitant disease or condition or treatment that could interfere with the conduct of the study or would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study

• Allergy to lidocaine

• Suspicion of regular consumption of drug of abuse

• Regular smoker (> 5 cigarettes, > 1 pipeful or > 1 cigar per day)

• Positive for hepatitis B, hepatitis C or HIV 1 or 2 infection

• Participation in an investigational drug or device study (last administration of study drug or installation of device) within 6 weeks before RO5508887 administration and within 5 mean half-lives of receiving previous investigational drug before RO5508887 administration. In addition, subject cannot participate unless completely recovered from previous invasive or study procedure

• Donation of blood over 500 mL within 6 weeks before drug administration

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Placebo
Single oral dose
• RO5508887
Single oral dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma levels of amyloid biomarkers		Pre-dose and up to fullow up, 8-12 days post dose	No
Primary	Cerebral spinal fluid levels of amyloid biomarkers		Pre-dose and up to 30 hours post-dose	No
Secondary	Safety: Incidence of adverse events		approximately 6 months	No
Secondary	Pharmacokinetics: Plasma and cerebral spinal fluid concentrations of RO5508887 (and metabolites)		Pre-dose and up to 72 hours post-dose	No