A Single-Center Study of RO5508887 in Healthy Volunteers

Healthy Volunteer Clinical Trial

Official title:

A Single-Center, Randomized, Investigator/Subject-Blind, Multiple Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5508887 Following Oral Administration in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01664143
• Other study ID #: WP28102
• Secondary ID: 2012-000280-24
• Status: Completed
• Phase: Phase 1
• First received: August 8, 2012
• Last updated: November 1, 2016
• Start date: July 2012
• Est. completion date: September 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM)
• Study type: Interventional

Clinical Trial Summary

This single-center, randomized, double-blind, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. Volunteers will receive multiple-ascending doses of RO5508887 or matching placebo. The anticipated time on study treatment is 14 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult healthy volunteers, >/=18 years of age

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

• Use of adequate contraception methods or surgically sterile

Exclusion Criteria:

• Evidence of active or chronic disease

• Regular consumption of drugs of abuse

• Regular smoker (>5 cigarettes per day)

• Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)

• History of significant allergic reactions

• Abnormal blood pressure

• Clinical significant abnormalities (e.g., cardiovascular, laboratory values)

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Placebo
Multiple doses of placebo
• RO5508887
Multiple doses of RO5508887

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: incidence of adverse events		30 days	No
Secondary	Correlation of the age on pharmacokinetics of RO5508887		30 days	No
Secondary	Correlation of the age on pharmacodynamics of RO5508887		30 days	No
Secondary	Pharmacokinetics: plasma levels of RO5508887		Predose and up to 144 hours post last dose, and at follow-up	No
Secondary	Pharmacodynamics: Plasma levels of amyloid deposition markers		Predose and up to 144 hours post last dose	No
Secondary	Correlation of the age on safety of RO5508887		30 days	No