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

Healthy Volunteer Clinical Trial

Official title:

A Single-Center, Randomized, Investigator/Subject-Blind, Adaptive Single-Ascending Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food), and Pharmacodynamics of RO5545965 Following Oral Administration in Healthy Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01711801
• Other study ID #: BP28373
• Secondary ID: 2012-002869-35
• Status: Completed
• Phase: Phase 1
• First received: October 18, 2012
• Last updated: November 1, 2016
• Start date: October 2012
• Est. completion date: March 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Placebo
Single ascending dose
• RO5545965
Single ascending dose
• RO5545965
Single dose, in fed and fasted state

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	Safety: Incidence of adverse events		up to approximately 10 weeks	No
Secondary	Pharmacokinetics: Area under the concentration-time curve (AUC)		Pre-dose and up to 48 hours post-dose	No
Secondary	Pharmacokinetics: Maximum plasma concentration (Cmax)		Pre-dose and up to 48 hours post-dose	No
Secondary	Pharmacodynamics: Prolactin levels		Pre-dose and up to 10 hours post-dose	No
Secondary	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	No