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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: Placebo; Drug: RO5545965

• Registration Number: NCT01711801
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-18
• Study First Submitted QC: 2012-10-18
• Study First Posted: 2012-10-22
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1: Placebo	Placebo	-
Part 2: Food effect	RO5545965	-
Part 1: RO5545965	RO5545965	-

Primary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	up to approximately 10 weeks

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Area under the concentration-time curve (AUC)	Pre-dose and up to 48 hours post-dose
Effect of food on the pharmacokinetics of single dose RO55459965: Area under the concentration-time curve (AUC)	pre-dose and up to 48 hours post-dose
Pharmacokinetics: Maximum plasma concentration (Cmax)	Pre-dose and up to 48 hours post-dose
Pharmacodynamics: Prolactin levels	Pre-dose and up to 10 hours post-dose