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CompletedNCT01418963Updated Nov 2, 2016

A Study of RO5285119 in Healthy Volunteers

A Phase 1 interventional study of RO5285119 and placebo in Healthy Volunteer, sponsored by Hoffmann-La Roche. Completed at 2 sites in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
77
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteer
03

In context

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
77 participants (actual)

Study arms

  • Experimental
    Active

    Drug: RO5285119

  • Placebo comparator
    Placebo

    Drug: placebo

Interventions

  • DrugRO5285119

    single and multiple ascending oral doses

  • Drugplacebo

    single and multiple oral doses

06

What researchers measure

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: up to 5 weeks

Secondary outcomes

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

    Time frame: up to 5 weeks

  2. Pharmacodynamics (neurological effects): Profile of Mood States/Bond&Lader VAS/smell test/C-SSRS

    Time frame: up to 5 weeks

  3. Pharmacodynamics: Biomarker levels (ACTH, prolactin, cortisol, vasopressin)

    Time frame: up to 5 weeks

  4. Pharmacodynamics: Functional Magnetic Resonance Imaging

    Time frame: up to 5 weeks

  5. Food effect: Comparison of single dose pharmacokinetics (AUC) in fasted and fed state (Part 1b)

    Time frame: up to 5 weeks

07

Study locations

2 sites
  • Rennes, 35042, France
  • Strasbourg, 67064, France
08

References and documents

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. PubMed 34176392 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01418963
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Aug 17, 2011
Start date
Jul 2011
Primary completion
Jul 2012
Completion
Jul 2012
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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