A Study of Safety, Pharmacokinetics (Including Food Effect) And Pharmacodynamics of RO5545965 in Healthy Volunteers

NCT ID: NCT01711801

Last Updated: 2016-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-03-31

Brief Summary

This randomized, Investigator/Subject-blind, adaptive single-ascending-dose, placebo-controlled, parallel study will evaluate the safety, tolerability, pharmacokinetics (including the effect of food), and pharmacodynamics of RO5545965 following oral administration in healthy male volunteers. In Part 1, subjects will be randomized in cohorts to receive single ascending doses of RO5545965 or placebo. In Part 2, subjects will receive 2 doses of RO5545965, in the fed or fasted state, in randomized sequence with a washout period of approximately 2 weeks between treatment periods.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Part 1: Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single ascending dose

Part 1: RO5545965

Group Type: EXPERIMENTAL

RO5545965

Intervention Type: DRUG

Single ascending dose

Part 2: Food effect

Group Type: EXPERIMENTAL

RO5545965

Intervention Type: DRUG

Single dose, in fed and fasted state

Interventions

Placebo

Single ascending dose

Intervention Type: DRUG

RO5545965

Single ascending dose

Intervention Type: DRUG

RO5545965

Single dose, in fed and fasted state

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male volunteers, 18 to 45 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, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis
• Body mass index (BMI) 18 to 30 kg/m2 inclusive
• Male subjects (whether surgically sterilized or not) with female partners of child-bearing potential must use two forms of contraception, one of which must be a barrier method, for the duration of the study and for 77 days after the last dose

Exclusion Criteria

• History or presence of any clinically significant disease or disorder
• Any condition or disease that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator
• History of clinically significant hypersensitivity or allergic drug reactions
• Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse
• Regular smoker (> 5 cigarettes, > 1 pipeful or > 1 cigar per day)
• Positive for hepatitis B, hepatitis C or HIV infection
• Dietary restrictions that would prohibit the consumption of standardized meals
• Participation in an investigational drug or device study within 90 days prior to screening, as calculated from the follow-up from the previous study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Zuidlaren, , Netherlands

Countries

Netherlands

Other Identifiers

2012-002869-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP28373

Identifier Type: -

Identifier Source: org_study_id