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

NCT01711801 | Completed Phase 1

• 2 other identifiers: BP283732012-002869-35
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Safety: Incidence of adverse events

  up to approximately 10 weeks

Secondary Outcomes (4)

• Pharmacokinetics: 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

• 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

Study Arms (3)

Part 1: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Part 1: RO5545965

EXPERIMENTAL

Drug: RO5545965

Part 2: Food effect

EXPERIMENTAL

Drug: RO5545965

Interventions

Placebo DRUG

Single ascending dose

Part 1: Placebo

RO5545965 DRUG

Single ascending dose

Part 1: RO5545965

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Zuidlaren, 9471 GP, Netherlands

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 22, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

NL (1)