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A Study of RG7625 in Healthy Volunteers

NCT ID: NCT02295332

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

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-04-30

Brief Summary

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This is a single center, randomized, double-blind, placebo-controlled, single ascending dose study that will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of single doses of RG7625 in healthy male and female volunteers.

The study will employ an interleaved cohort ('leapfrog') design in which dosing is alternated between two cohorts and each individual within a cohort will receive study drug dosing on four occasions - in effect giving a four treatment, four period, four-way crossover for each individual. The minimum duration for each participant is approximately 8 weeks.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort A

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Matching oral placebo capsules to RG7625, according to treatment schedule

RG7625

Intervention Type DRUG

oral administration, capsules, single ascending dose according to treatment schedule

Cohort B

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Matching oral placebo capsules to RG7625, according to treatment schedule

RG7625

Intervention Type DRUG

oral administration, capsules, single ascending dose according to treatment schedule

Interventions

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Placebo

Matching oral placebo capsules to RG7625, according to treatment schedule

Intervention Type DRUG

RG7625

oral administration, capsules, single ascending dose according to treatment schedule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female participants, 18 to 60 years of age, inclusive
* A body mass index between 18 to 30 kg/m2 inclusive
* Able to participate and willing to give written informed consent and to comply with the study restrictions

Exclusion Criteria

* Any clinically relevant abnormalities, concomitant diseases or ongoing medical conditions, abnormal laboratory test results or a history of any other clinically significant disorders
* Any major illness within the one month preceding the screening visit, or any febrile illness within the two weeks preceding the screening visit
* Any significant allergic reaction to drugs
* Immunocompromised or with reduced immune function and/or immunization within 30 days before the first study drug administration or planning vaccination during the study
* Women who are pregnant or lactating or of childbearing potential
* Clinically significant abnormal ECG or other risk factors for QT prolongation
* Use of prescribed or over the counter medication
* Inability or unwillingness to comply with study requirements
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 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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Zuidlaren, , Netherlands

Site Status

Countries

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Netherlands

References

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Theron M, Bentley D, Nagel S, Manchester M, Gerg M, Schindler T, Silva A, Ecabert B, Teixeira P, Perret C, Reis B. Pharmacodynamic Monitoring of RO5459072, a Small Molecule Inhibitor of Cathepsin S. Front Immunol. 2017 Jul 17;8:806. doi: 10.3389/fimmu.2017.00806. eCollection 2017.

Reference Type DERIVED
PMID: 28769925 (View on PubMed)

Other Identifiers

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2014-003538-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

WP29542

Identifier Type: -

Identifier Source: org_study_id