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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: RO5508887

Study type: Interventional

Funder types: Industry

Identifiers

NCT01461967

WP25752

2011-002053-54 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

49 participants in 3 patient groups, including a placebo group

Part 1a

Experimental group

Treatment:

Drug: RO5508887

Drug: RO5508887

Part 1b

Placebo Comparator group

Treatment:

Drug: Placebo

Part 2

Experimental group

Treatment:

Drug: RO5508887

Drug: RO5508887