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A Study of RO5285119 in Healthy Volunteers

NCT ID: NCT01418963

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active

Group Type EXPERIMENTAL

RO5285119

Intervention Type DRUG

single and multiple ascending oral doses

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

single and multiple oral doses

Interventions

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RO5285119

single and multiple ascending oral doses

Intervention Type DRUG

placebo

single and multiple oral doses

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Rennes, , France

Site Status

Strasbourg, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 34176392 (View on PubMed)

Other Identifiers

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BP25694

Identifier Type: -

Identifier Source: org_study_id