Clinical trial NCT01864226: A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5545965 in Healthy Volunteers
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-05-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: approximately 3 months
Secondary outcomes:
measure: Pharmacokinetics: Area under the concentration-time curve (AUC)
timeFrame: 17 days
measure: Pharmacokinetics: Plasma concentrations
timeFrame: 17 days
measure: Pharmacokinetics: Urine concentrations
timeFrame: 13 days
measure: Pharmacodynamics: Serum prolactin levels
timeFrame: Day 12
measure: Pharmacodynamics: Glucose tolerance test
timeFrame: Day 11
measure: Pharmacodynamics: Probabilistic learning tasks
timeFrame: Days 6, 8 and 10
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: