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

Healthy Volunteer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864226
• Other study ID #: BP28845
• Status: Completed
• Phase: Phase 1
• First received: May 24, 2013
• Last updated: November 1, 2016
• Start date: June 2013
• Est. completion date: January 2014

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Centrale Commissie Mensgebonden Onderzoek
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO5545965
Multiple ascending doses
• placebo
Multiple ascending doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		approximately 3 months	No
Secondary	Pharmacokinetics: Area under the concentration-time curve (AUC)		17 days	No
Secondary	Pharmacokinetics: Plasma concentrations		17 days	No
Secondary	Pharmacokinetics: Urine concentrations		13 days	No
Secondary	Pharmacodynamics: Serum prolactin levels		Day 12	No
Secondary	Pharmacodynamics: Glucose tolerance test		Day 11	No
Secondary	Pharmacodynamics: Probabilistic learning tasks		Days 6, 8 and 10	No