A Study of RO5285119 in Healthy Volunteers

A Single- and Multiple Ascending-Dose, Randomized, Double-Blind, Placebo-Controlled Study in Two Single-Center Study Parts to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5285119 Following Oral Administration in Healthy Subjects

This two-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of RO5285119 in healthy volunteers. Anticipated time on study will be up to 9 weeks for each subject.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: RO5285119; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35042
  • Strasbourg, France, 67064

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male adults, 18 to 45 years of age (Part 1) or healthy male or female adults, 18 to 65 years of age (Part 2)
• Body mass index (BMI) 18.0 to 30.0 kg/m2 inclusive
• Female subjects must be surgically sterile or postmenopausal
• Male subjects must use a barrier method of contraception for the duration of the study and for the three months after the last dosing

Exclusion Criteria:

• History or presence of any significant disease or disorder
• Positive for hepatitis B. hepatitis C or HIV infection
• History of drug or alcohol abuse or suspicion of regular consumption of drugs of abuse
• Participation in an investigational drug or device study within 3 months prior to first dosing
• Donation of blood within 3 months prior to first dosing
• Regular smoker (>5 cigarettes, >3 pipe-fulls, >3 cigars per day)
• History of hypersensitivity or allergic reactions
• Part 2: Contraindications for MRI scans

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: placebo; single and multiple oral doses
Experimental: Active	Drug: RO5285119; single and multiple ascending oral doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety: Incidence of adverse events	up to 5 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics: Area under the concentration - time curve (AUC)	up to 5 weeks
Pharmacodynamics (neurological effects): Profile of Mood States/Bond&Lader VAS/smell test/C-SSRS	up to 5 weeks
Pharmacodynamics: Biomarker levels (ACTH, prolactin, cortisol, vasopressin)	up to 5 weeks
Pharmacodynamics: Functional Magnetic Resonance Imaging	up to 5 weeks
Food effect: Comparison of single dose pharmacokinetics (AUC) in fasted and fed state (Part 1b)	up to 5 weeks

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Derks M, Lennon-Chrimes S, Guenther A, Squassante L, Wandel C, Szczesny P, Paehler A, Kletzl H. Bioavailability and pharmacokinetic profile of balovaptan, a selective, brain-penetrant vasopressin 1a receptor antagonist, in healthy volunteers. Expert Opin Investig Drugs. 2021 Aug;30(8):893-901. doi: 10.1080/13543784.2021.1948009. Epub 2021 Jul 16.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: August 15, 2011
• First Submitted That Met QC Criteria: August 16, 2011
• First Posted (Estimate): August 17, 2011

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: BP25694