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

NCT01864226 | Completed Phase 1

• 1 other identifier: BP28845
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Safety: Incidence of adverse events

  approximately 3 months

Secondary Outcomes (6)

• Pharmacokinetics: Area under the concentration-time curve (AUC)

  17 days

• Pharmacokinetics: Plasma concentrations

  17 days

• Pharmacokinetics: Urine concentrations

  13 days

• Pharmacodynamics: Serum prolactin levels

  Day 12

• Pharmacodynamics: Glucose tolerance test

  Day 11

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: placebo

RO5545965

EXPERIMENTAL

Drug: RO5545965

Interventions

RO5545965 DRUG

Multiple ascending doses

RO5545965

placebo DRUG

Multiple ascending doses

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Zuidlaren, 9471 GP, Netherlands

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: May 29, 2013
• Study Start: June 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

NL (1)