MedDataX Logo

This is a Single Ascending Dose Tolerance Study

NCT ID: NCT01133574

Last Updated: 2011-08-29

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a single rising dose tolerance (Part A) followed by a functional magnetic resonance imaging (Part B)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Safety Study of LY2811376 Single Doses in Healthy Subjects

NCT00838084

Alzheimer's Disease
COMPLETED PHASE1

ELND005 in Patients With Mild to Moderate Alzheimer's Disease

NCT00568776

Alzheimer Disease
COMPLETED PHASE2

Efficacy and Safety Study of ABT-384 in Subjects With Mild-to-Moderate Alzheimer's Disease

NCT01137526

Alzheimer's Disease
COMPLETED PHASE2

A Safety Study of LY2886721 Single Doses in Healthy Subjects

NCT01133405

Alzheimer's Disease
COMPLETED PHASE1

A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease

NCT00930059

Alzheimer's Disease
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The Part A of this study is a parallel design followed in a second part by a cross-over design

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cognition Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A1

Part A, Parallel design Arm 1

Group Type EXPERIMENTAL

SLV354 capsules

Intervention Type DRUG

20 mg

A2

Part A, Parallel design Arm 2

Group Type EXPERIMENTAL

SLV354 capsules

Intervention Type DRUG

60 mg

A3

Part A, Parallel design Arm 3

Group Type EXPERIMENTAL

SLV354 capsules

Intervention Type DRUG

120 mg

A4

Part A, Parallel design Arm 4

Group Type EXPERIMENTAL

SLV354 capsules

Intervention Type DRUG

250 mg

A5

Part A, Parallel design Arm 5

Group Type EXPERIMENTAL

SLV354 capsules

Intervention Type DRUG

500 mg

A6

Part A, Parallel design Arm 6

Group Type EXPERIMENTAL

SLV354 capsules

Intervention Type DRUG

750 mg

A7

Part A, Parallel design Arm 7

Group Type EXPERIMENTAL

SLV354 capsules

Intervention Type DRUG

1000 mg

A8

Part A, Parallel design Arm 8

Group Type EXPERIMENTAL

SLV354 capsules

Intervention Type DRUG

1250 mg

A9

Part A, Parallel design Arm 9

Group Type PLACEBO_COMPARATOR

Placebo capsules

Intervention Type DRUG

placebo

B1-1

Part B, Cross-over design, Arm 1

Group Type EXPERIMENTAL

SLV354 capsules

Intervention Type DRUG

low dose group 1

B1-2

Part B, Cross-over design, Arm 2

Group Type EXPERIMENTAL

SLV354 capsules

Intervention Type DRUG

high dose group 1

B2-1

Part B, Cross-over design, Arm 3

Group Type EXPERIMENTAL

SLV354 capsules

Intervention Type DRUG

low dose group 2

B2-2

Part B, Cross-over design, Arm 4

Group Type EXPERIMENTAL

SLV354 capsules

Intervention Type DRUG

high dose group 2

B3

Part B, Cross-over design, Arm 5

Group Type PLACEBO_COMPARATOR

Placebo capsules

Intervention Type DRUG

placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SLV354 capsules

20 mg

Intervention Type DRUG

SLV354 capsules

60 mg

Intervention Type DRUG

SLV354 capsules

120 mg

Intervention Type DRUG

SLV354 capsules

250 mg

Intervention Type DRUG

SLV354 capsules

500 mg

Intervention Type DRUG

SLV354 capsules

750 mg

Intervention Type DRUG

SLV354 capsules

1000 mg

Intervention Type DRUG

SLV354 capsules

1250 mg

Intervention Type DRUG

Placebo capsules

placebo

Intervention Type DRUG

SLV354 capsules

low dose group 1

Intervention Type DRUG

SLV354 capsules

high dose group 1

Intervention Type DRUG

SLV354 capsules

low dose group 2

Intervention Type DRUG

SLV354 capsules

high dose group 2

Intervention Type DRUG

Placebo capsules

placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* BMI 18.0 to 28.0 kg/m2,
* systolic blood pressure 90-140 mmHg,
* diastolic blood pressure 50-90 mmHg,
* heart rate 50 100 beats/min (all inclusive),
* clinically normal safety ECG and laboratory results

Exclusion Criteria

* relevant disease,
* treated with SLV354 before
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Quintiles, Inc.

INDUSTRY

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Beatrice Rendenbach-Mueller, PhD

Role: STUDY_DIRECTOR

Abbott

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Site Reference ID/Investigator# 62002

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009-017008-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

S354.1.001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Single Ascending Oral Dose Study of SDI-118 in Healthy Male Subjects Including an Assessment of Receptor Occupancy and Food Effect
NCT05486195 COMPLETED PHASE1
A Multicenter, Double Blind, Placebo-Controlled, Safety and Tolerability Study of BMS-708163 in Patients With Prodromal Alzheimer's Disease
NCT00890890 TERMINATED PHASE2
A Randomized, Double-blind, Placebo-controlled, Sequential Ascending, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2212 in Healthy Subjects
NCT01221259 COMPLETED PHASE1
Study to Assess Adverse Events, Change in Disease Activity and How Oral ABBV-552 Capsules Moves Through the Body of Participants Aged 50 to 90 Years With Mild Alzheimer's Disease
NCT05771428 COMPLETED PHASE2
A Study of LY3372993 in Healthy Participants and Participants With Alzheimer's Disease (AD)
NCT03720548 COMPLETED PHASE1
A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease
NCT03131453 TERMINATED PHASE2/PHASE3
A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD
NCT05231785 RECRUITING PHASE1
Safety and Efficacy Study of ABT-089 in Adults With Mild to Moderate Alzheimer's Disease
NCT00555204 TERMINATED PHASE2
Proof of Concept Study of Cognitive Improvement in Patients With Alzheimer's Disease
NCT00501111 COMPLETED PHASE2
A Trial of the Safety, Tolerability, and Pharmacodynamics of CVL-871 in Subjects With Dementia-Related Apathy
NCT04958031 COMPLETED PHASE2
Safety, Tolerability and the Effects on Cerebrospinal Fluid Spectrin Breakdown Product-145 Levels of ABT-957 in Subjects With Mild Alzheimer's Disease and Mild Cognitive Impairment
NCT02573740 TERMINATED PHASE1
Study of LM11A-31-BHS in Mild-moderate AD Patients
NCT03069014 COMPLETED PHASE1/PHASE2
Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance
NCT03980730 TERMINATED PHASE2
Safety and Efficacy Study of AC-3933 in Adults With Mild to Moderate Alzheimer's Disease
NCT00359944 COMPLETED PHASE2
Clinical Study Evaluating Efficacy and Safety of T3D-959 in Mild-to-moderate AD Subjects
NCT04251182 COMPLETED PHASE2
An Escalating Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LNK 754 in Elderly Volunteers and in Subjects With Mild Alzheimer's Disease
NCT01013610 COMPLETED PHASE1
Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia
NCT00099216 COMPLETED PHASE3
A Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Anti-Abeta (MABT5102A) in Patients With Alzheimer's Disease
NCT00736775 COMPLETED PHASE1
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-54861911 in Healthy Elderly Participants
NCT01887535 COMPLETED PHASE1
Multiple Dose Safety Study of NPT088 in Patients With Mild to Moderate Probable Alzheimer's Disease
NCT03008161 COMPLETED PHASE1
Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease
NCT03352557 TERMINATED PHASE2
A Study of LY3154207 in Participants With Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB)
NCT03305809 COMPLETED PHASE2
An Efficacy and Safety Study of Galantamine for the Treatment of Patients With Alzheimer's Disease.
NCT00301574 COMPLETED PHASE3
Efficacy and Safety of 3 Doses of S47445 Versus Placebo in Patients With Alzheimer's Disease at Mild to Moderate Stages With Depressive Symptoms
NCT02626572 COMPLETED PHASE2
A Clinical Study to Assess Single and Repeat Doses of a New Medication (GSK933776) in Patients With Alzheimer's Disease
NCT00459550 COMPLETED PHASE1