A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy Volunteers

Healthy Volunteer Clinical Trial

Official title:

A Single-Center, Randomized, Double-Blind, Single and Multiple Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food) and Pharmacodynamics of RO5508887 Following Oral Administration in Healthy Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461967
• Other study ID #: WP25752
• Secondary ID: 2011-002053-54
• Status: Completed
• Phase: Phase 1
• First received: October 24, 2011
• Last updated: November 1, 2016
• Start date: September 2011
• Est. completion date: December 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

This randomized, double-blind, placebo-controlled, cross-over study will assess the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. In Part 1, subjects will be randomized to receive single ascending doses of either RO5508887 or placebo. In Part 2, subjects will receive a single dose of RO5508887 on two occasions, with or without food. Anticipated time on study is up to 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy male volunteers, 18-45 (Part 1) or 18-65 (Part 2) years of age inclusive; healthy status is defined by absence of evidence of any active or chronic disease

• Body Mass Index (BMI) 18 to 30 kg/m2 inclusive

• Male subjects must use a barrier method of contraception for the duration of the study and for 30 days after the last dose

Exclusion Criteria:

• Suspicion of regular consumption of drugs of abuse

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

• Positive for hepatitis B, hepatitis C or HIV infection

• History of hypersensitivity or severe drug reaction

• Participation in an investigational drug or device study within three months before the first drug administration

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Placebo
Single ascending doses
• RO5508887
Single ascending doses
• RO5508887
Single doses

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/tolerability: Incidence of adverse events		up to approximately 8 weeks	No
Secondary	Pharmacokinetics: Plasma concentrations of RO5508887		predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 48, 72, 96, 144 hours post-dose	No
Secondary	Pharmacodynamics: Urine levels of RO5508887		predose to 72 hours post-dose	No
Secondary	Pharmacodynamics: Plasma levels of markers of amyloid deposition (Abeta1-40/Abeta1-42)		predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 48, 72, 96, 144 hours post-dose	No
Secondary	Effect of food on pharmacokinetics (plasma concentrations) of a single dose of RO5508887		predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 36, 48, 60, 72 hours post-dose	No