Zuidlaren, 9471 GP, Netherlands
NCT Number: NCT01711801
A Study of Safety, Pharmacokinetics (Including Food Effect) And Pharmacodynamics of RO5545965 in Healthy Volunteers
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.
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Notify MeKey information
Conditions
Age range
18 year–45 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Placebo
DrugSingle ascending dose
RO5545965
DrugSingle ascending dose
Primary outcomes
-
Safety: Incidence of adverse events
Time frame: up to approximately 10 weeks
Secondary outcomes
-
Pharmacokinetics: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to 48 hours post-dose
-
Pharmacokinetics: Maximum plasma concentration (Cmax)
Time frame: Pre-dose and up to 48 hours post-dose
-
Pharmacodynamics: Prolactin levels
Time frame: 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)
Time frame: pre-dose and up to 48 hours post-dose
Sponsors and collaborators
Lead sponsor
Hoffmann-La Roche
Industry
Registry information
Official study 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.
Important dates
- Study start
- 2012
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Oct 22, 2012
- Registry last updated
- Nov 2, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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