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A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5545965 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01864226
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: RO5545965 Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 Start Date : June 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: placebo
Multiple ascending doses

Experimental: RO5545965 Drug: RO5545965
Multiple ascending doses

Primary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: approximately 3 months ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: 17 days ]
  2. Pharmacokinetics: Plasma concentrations [ Time Frame: 17 days ]
  3. Pharmacokinetics: Urine concentrations [ Time Frame: 13 days ]
  4. Pharmacodynamics: Serum prolactin levels [ Time Frame: Day 12 ]
  5. Pharmacodynamics: Glucose tolerance test [ Time Frame: Day 11 ]
  6. Pharmacodynamics: Probabilistic learning tasks [ Time Frame: Days 6, 8 and 10 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01864226

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Zuidlaren, Netherlands, 9471 GP
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche Identifier: NCT01864226     History of Changes
Other Study ID Numbers: BP28845
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016