Zuidlaren, 9471 GP, Netherlands
NCT Number: NCT01864226
A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5545965 in Healthy Volunteers
This single-center, randomized, investigator/subject-blind, adaptive multiple ascending-dose, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5545965 in healthy volunteers. Subjects will be randomized to receive either RO5545965 or matching placebo daily for 12 days.
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Notify MeKey information
Conditions
Age range
18 year–64 year
Sex eligibility
All sexes
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
- Adult male and female volunteers, 18 - 64 years of age, inclusive Healthy status is defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a complete physical examination
- Body mass index (BMI) 18 to 30 kg/m2 inclusive
- Female subject must be post-menopausal or surgically sterile
- Male subjects with female partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method, for the duration of the study and for at least 30 days after the last dose of study drug
Exclusion criteria
- History of any clinically significant disease or disorder
- Concomitant disease or condition that could interfere with, or the treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
- Clinically significant abnormalities in laboratory test results
- Suspicion of regular consumption of drug of abuse
- Positive for hepatitis B, hepatitis C or HIV infection
- Participation in an investigational drug or device study within 90 days prior to screening
- Regular smoker (>5 cigarettes, >1 pipeful or >1 cigar per day)
- History of clinically significant hypersensitivity or allergic drug reactions
Treatment and study plan
RO5545965
DrugMultiple ascending doses
Placebo
DrugMultiple ascending doses
Primary outcomes
-
Safety: Incidence of adverse events
Time frame: approximately 3 months
Secondary outcomes
-
Pharmacokinetics: Area under the concentration-time curve (AUC)
Time frame: 17 days
-
Pharmacokinetics: Plasma concentrations
Time frame: 17 days
-
Pharmacokinetics: Urine concentrations
Time frame: 13 days
-
Pharmacodynamics: Serum prolactin levels
Time frame: Day 12
-
Pharmacodynamics: Glucose tolerance test
Time frame: Day 11
-
Pharmacodynamics: Probabilistic learning tasks
Time frame: Days 6, 8 and 10
Sponsors and collaborators
Lead sponsor
Hoffmann-La Roche
Industry
Registry information
Official study title
A Single-Center, Randomized, Investigator/Subject-Blind, Adaptive Multiple Ascending-Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5545965 Following Oral Administration in Healthy Subjects.
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- May 29, 2013
- 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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