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OpenTrials
Completed

NCT Number: NCT02295332

A Study of RG7625 in Healthy Volunteers

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zuidlaren, 9471 GP, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Matching oral placebo capsules to RG7625, according to treatment schedule

RG7625

Drug

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

Primary outcomes

  1. Safety (composite outcome measure):Incidence and severity of adverse events (AEs), laboratory abnormalities, changes in ECG, vital signs

    Time frame: Approximately 22 weeks

Secondary outcomes

  1. Pharmacokinetics (composite outcome measure): PK profile and parameters derived from plasma concentrations of RG7625 and its metabolites [AUCinf, AUClast, Cmax, tmax, t1/2, CL/F, V/F, Ae, fe and CLR]

    Time frame: 22 weeks

  2. Pharmacodynamics (composite outcome measure): measurement of intracellular p10 concentrations and cell surface expression of major histocompatibility complex class (MHC)-II, relationship to RG7625 exposure

    Time frame: 22 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2014
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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