NCT01418963

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

August 15, 2011

Last Update Submit

November 1, 2016

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • Safety: Incidence of adverse events

    up to 5 weeks

Secondary Outcomes (5)

  • 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

Study Arms (2)

Active

EXPERIMENTAL
Drug: RO5285119

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

RO5285119DRUG

single and multiple ascending oral doses

Active
placeboDRUG

single and multiple oral doses

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Rennes, 35042, France

Location

Unknown Facility

Strasbourg, 67064, France

Location

Related Publications (1)

  • 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.

    PMID: 34176392DERIVED

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

August 15, 2011

First Posted

August 17, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

FR(2)