罗氏制药

关于唐氏综合征改善智力低下药物RG1662  Ⅰ 期临床信息

Comparative bioavailability study of film-coated tablet and granuleformulations of RG1662

Status:

Completed

Protocol number:

WP28978

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Product name:

RG1662

Official Scientific Title:

A Randomized, Open-Label, Four Period, Four-Treatment Crossover Study toInvestigate the Comparative Bioavailability of Film-Coated Tablet and GranuleFormulations of RG1662 Under Fed and Fasted Conditions in Healthy Volunteers

Brief summary:

This study will compare the pharmacokinetic performance of film-coatedtablet and granule formulations of RG1662 under fed and fasted conditions inhealthy volunteers. A randomized, four-period, four-treatment crossover designis used. In each period, each volunteer will receive a single oral dose of thetablet or granule formulation either with or without food. Target sample sizeis 18.

Study phase:

I

Study type:

Interventional; Other; Randomized; Open label; Crossover; Bio-availabilitystudy

Conditions:

·         Healthy Volunteer

Primary outcome:

1.    Tablet Fed (reference): RG1662 plasmaexposure, area under the concentration-time curve Time frame: Up to 9 weeks

2.    Tablet Fasted (reference): RG1662 plasmaexposure, area under the concentration-time curve Time frame: Up to 9 weeks

3.    Granules Fed (test): RG1662 plasmaexposure, area under the concentration-time curve Time frame: Up to 9 weeks

4.    Granules Fasted (test): RG1662 plasmaexposure, area under the concentration-time curve Time frame: Up to 9 weeks

Key secondary outcomes:

1.    Tablet formulation: RG1662 plasma exposureratio between fed (test) and fasted (reference) conditions, estimated from areaunder the concentration-time curve measurements Time frame: Up to 9 weeks

2.    Granule formulation: RG1662 plasmaexposure ratio between fed (test) and fasted (reference) conditions, estimatedfrom area under the concentration-time curve measurements Time frame: Up to 9weeks

3.    Palatability of the granule formulation,as assessed by questionnaire Time frame: Day 1, Day 3 in granule administrationperiods

4.    Safety: Incidence of adverse events witheither formulation Time frame: Up to 9 weeks

Inclusion criteria:

·         Male or female volunteers, 18 to 60 yearsof age, inclusive

Exclusion criteria:

·         A history of epilepsy, convulsions orsignificant head injury

·         Any other clinically relevantabnormalities, concomitant diseases or ongoing medical conditions

Gender:

Males or Females

Age limits:

Min: 18 years Max: 60 years

Accepts healthy volunteers:

Yes

Anticipated start date:

August, 2014

Trial registration date:

10.06.2014

Date last updated:

08.05.2015

This trial was conducted at thefollowing locations:

UNITEDKINGDOM

·         LEEDS

来源罗氏制药公司网站。网址：http://www.roche-trials.com/trialDetailsGet.action?studyNumber=WP28978

罗氏制药关于唐氏综合征改善智力低下药物RG1662 Ⅱ期临床信息

A Study of RG1662 in Adults and Adolescents with Down Syndrome (CLEMATIS)

Status:

Recruiting

Protocol number:

BP27832

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Product name:

RG1662

Official Scientific Title:

A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 STUDYOF THE EFFICACY, SAFETY AND TOLERABILITY OF RG1662 IN ADULTS AND ADOLESCENTSWITH DOWN SYNDROME (CLEMATIS)

Brief summary:

This multi-center, randomized, double-blind, 3-arm, parallel-group,placebo-controlled study will evaluate the efficacy and safety of RG1662 inadults and adolescents with Down syndrome. Subjects will be randomized toreceive RG1662 either at low or high dose or placebo orally twice daily for 26weeks. Target sample size is 180.

Study phase:

II

Study type:

Interventional; Treatment; Randomized; Double Blind; Parallel;Safety/efficacy study

Conditions:

·         Down Syndrome

Primary outcome:

1.    Cognition as assessed by the RepeatableBattery for the Assessment of Neuropsychological Status (RBANS) sub-tests Timeframe: 26 weeks

2.    Adaptive behavior as assessed by theVineland Adaptive Behavior Scales-II (VABS-II) standard scores Time frame: 26weeks

3.    Clinical global impression as assessed byClinician Rated Global Improvement (CGI-I) scale Time frame: 26 weeks

Key secondary outcomes:

1.    Safety: Incidence of adverse events Timeframe: approximately 32 weeks

2.    Incidence of abnormal ECG changes Timeframe: 26 weeks

3.    Abnormal ECG changes in adolescents ascompared to baseline Time frame: from baseline to Week 26

4.    Incidence of abnormal blood pressure Timeframe: 26 weeks

5.    RG1662 plasma concentrations Time frame:26 weeks

Inclusion criteria:

·         Individuals aged 12-30 years of ageinclusive

·         Clinical diagnosis of Down syndrome(trisomy 21) confirmed by chromosomal analysis (karyotyping)

·         Males, or non-pregnant, non-lactatingfemales. For females of childbearing potential, strict contraceptive preventionis required.

·         Body-mass Index (BMI) 18-42 and 15-30kg/m2 inclusive for adults and adolescents respectively

·         Ability to complete the ClinicalEvaluation of Language Fundamentals (CELF)-preschool 2 word classes task

·         Subjects must have a parent, or otherreliable caregiver who agrees to accompany the subject to all clinic visits,provide information about the subject as required by the protocol, and ensurecompliance with the medication schedule

·         Study participants must have sufficientlanguage, vision and hearing to participate in study evaluations, as judgedclinically by investigator

Exclusion criteria:

·         Subjects with a current DSM 5 diagnosis ofany primary psychiatric diagnosis (including ASD or MDD)

·         Subjects with a history of infantilespasms, of West syndrome, Lennox-Gastaut syndrome, Early Infantile EpilepticEncephalopathy or any treatment-refractory epilepsy associated with cognitiveor developmental regression, of severe head trauma or CNS infections (e.g.meningitis)

·         Subjects with a known or suspectedclinical seizure event of any type within 24 months prior to screening

·         Clinically relevant ECG abnormalities atscreening or baseline; QTcF above 450 ms; personal or family history (firstdegree relatives) of congenital long QT syndrome

·         Inadequate renal or hepatic function

Gender:

Males or Females

Age limits:

Min: 12 years Max: 30 years

Accepts healthy volunteers:

No

Anticipated start date:

May, 2014

Trial registration date:

25.11.2013

Date last updated:

08.05.2015

This trial is being conducted at thefollowing locations:

ARGENTINA

·         CABA

·         Ciudad Autonoma de Bs As

CANADA

·         Kentville,, Nova

FRANCE

·         Bron

·         MONTPELLIER

·         Paris

·         St Etienne

ITALY

·         Roma, Lazio

·         CAGLIARI, Sarde

MEXICO

·         Aguascalientes

·         Guadalajara

·         MONTERREY

·         Queretaro

NEWZEALAND

·         Auckland

·         Dunedin

·         Wellington

SINGAPORE

·         Singapore

SPAIN

·         Barcelona, BARCE

·         Salt, GIRON

·         Santiago de Compostela, LA CO

·         Madrid, MADRI

UNITEDKINGDOM

·         Blackpool

·         Dartford, Kent

·         Doncaster

·         Redruth

UNITEDSTATES

·         La Jolla, CA

·         Sacramento, CA

·         Decatur, GA

·         Chicago, IL

·         Boston, MA

·         Baltimore, MD

·         Durham, NC

·         Dallas, TX

·         Salt Lake City, UT

·         Madison, WI

来源罗氏制药网站。网址：http://www.roche-trials.com/trialDetailsGet.action?studyNumber=BP27832