A Study of RO6799477 in Healthy Volunteers

Healthy Volunteer Clinical Trial

Official title:

A Single-center, Randomized, Double-blind, Placebo-controlled, Single Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6799477 Following Oral Administration of Single Ascending Doses in Healthy Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893437
• Other study ID #: BP28751
• Secondary ID: 2013-000402-28
• Status: Completed
• Phase: Phase 1
• First received: June 27, 2013
• Last updated: November 1, 2016
• Start date: July 2013
• Est. completion date: October 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Centrale Commissie Mensgebonden Onderzoek (CCMO)
• Study type: Interventional

Clinical Trial Summary

This single-center, randomized, double-blind, placebo-controlled, single dose study will investigate the safety, pharmacokinetics, pharmacodynamics of RO6799477 in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Male healthy volunteers, aged 18-45 years, inclusive

• Male volunteers with female partner of childbearing potential must agree to use an effective form of birth control during the study and for 3 months after discontinuation of treatment.

• Body Mass index (BMI) of 18-30 kg/m2, inclusive

Exclusion Criteria:

• Infection with human immunodeficiency virus antibody (HIV 1 and 2), Hepatitis B, hepatitis C

• Positive testing for drugs of abuse

• Any history of alcohol and/or drug of abuse addiction

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:
• RO6799477
Single doses of RO6799477

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Safety: Incidence of adverse events		18 weeks	No
Secondary	Part 1 and 2: Pharmacokinetics: plasma concentration of RO6799477		Pre-dose, Day 1, 2, 3, 4	No