Condition category
Signs and Symptoms
Date applied
18/04/2012
Date assigned
23/05/2012
Last edited
27/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
DSP-2230 is a new drug that has shown promising results in reducing the feeling of pain in animal models. The main aim of the study is to assess the safety of the drug in humans and how well the drug is tolerated when given as single increasing doses to healthy male and female volunteers. In addition, the drug levels in the body and how fast the drug and its breakdown products get into and out of the blood system will also be investigated.

Who can participate?
Healthy men and women aged 18 to 55 years

What does the study involve?
The study involves 3 parts but volunteers only choose to participate in one part. Volunteers will attend a screening visit which will take place up to 21 days before the main study starts. They will have a full medical examination. They will have blood and urine tests which involve taking blood samples. If volunteers decide to take part in the main part of the trial, they will attend the Unit on several occasions as follows:
Part 1: 4 times, one of which will involve staying in the centre for 4 continuous nights.
Part 2: 3 times, one of which will involve staying in the centre for 4 continuous nights.
Part 3: 4 times, one of which will involve staying in the centre for 17 continuous nights.
During this time you will receive study drug or placebo and have blood and urine samples taken. You will also have your vital signs measured and be asked to perform a set of cognitive function tests.

What are the possible benefits and risks of participating?
Volunteers will not receive any direct medical benefit from participating in this study, but a potential benefit could be the detection of an unsuspected medical condition from tests performed. Volunteers may feel discomfort during some of the tests or experience some inconveniences. Drawing blood from your arm may cause pain, bruising, light headedness and (rarely) infection. Since DSP-2230 is an investigational drug there may be some unexpected side effects.

Where is the study run from?
ICON Development Solutions, Manchester, United Kingdom

When is study starting and how long is it expected to run for?
May 2012 to December 2012

Who is funding the study?
Dainippon Sumitomo Pharma Europe Ltd

Who is the main contact?
Dr Peter Dewland
peter.dewland2@iconplc.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peter Dewland

ORCID ID

Contact details

ICON Development Solutions
Skelton House
Manchester Science Park
Manchester
M15 6SH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

D8450052

Study information

Scientific title

A phase I, three part study, in healthy subjects to assess the safety, tolerability and pharmacokinetics of single and multiple doses of DSP-2230, and the effect of the administration in the fed and fasted states on the pharmacokinetics of DSP-2230.

Acronym

Study hypothesis

Three stages:
1. To assess the safety, tolerability and PK of single ascending doses of DSP-2230
2. To assess the effect of the administration of DSP-2230 in the fed and fasted states on the PK of DSP-2230
3. To assess the safety, tolerability and PK of multiple ascending doses of DSP-2230 after 14 days of dosing

Ethics approval

Not provided at time of registration

Study design

Parts 1 & 3 = randomised double-blind placebo-controlled escalating dose sequential trial
Part 2 = randomised open-label 2-way crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format. Please use the contact details below to request a subject information sheet

Condition

Peripheral neuropathic pain

Intervention

Part 1: A single dose of DSP-2230 or placebo will be orally administered in the fasted state. Dose for the first cohort of Part 1 will not exceed 3mg
Part 2: DSP-2230 will be orally administered.
Part 3: DSP-2230 or placebo will be orally administered in the fed state for up to 14 days.

Intervention type

Drug

Phase

Phase I

Drug names

DSP-2230

Primary outcome measures

1. Safety - Adverse Events (AEs)
2. Serious Adverse Events (SAEs)
3. Vital signs
4. Electrocardiogram (ECG)
5. ECT time intervals
6. Clinical chemistry, haematology and urinalysis
7. Pharmacokinetic - Plasma and urinary PK parameters of DSP-2230 and its metabolite
8. Pharmacodynamic - Pharmacodynamic parameters of the cognitive test battery

Secondary outcome measures

No secondary outcome measures

Overall trial start date

15/05/2012

Overall trial end date

15/01/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males and females of non-childbearing potential [Parts 1 and 2]
2. Females of childbearing potential [Part 3]
3. In good health
4. Aged 18 to 55 years
5. No evidence of systemic disease
6. Able to comply with all aspects of the protocol
7. Able to give written informed consent to participate in the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Part 1: 72 subjects; Part 2: 12 subjects; Part 3: 72 subjects - Total 156 subjects.

Participant exclusion criteria

1. All subjects will not have, or have had a history of, clinically significant neurological, gastrointestinal, renal, hepatic, caridovascular, psychological, metabolic, endocrine, haematological or other major disorders
2. They will not have, or have had a history of, drug or alcohol abuse
3. They will not have participated in a clinical study with an investigational medicinal product (IMP) within 3 months of randomisation into the current study
4. They will not have donated or lost >500mL of blood or blood products in the 3 months preceding the start of dosing

Recruitment start date

15/05/2012

Recruitment end date

15/01/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

ICON Development Solutions
Manchester
M15 6SH
United Kingdom

Sponsor information

Organisation

Sunovion Pharmaceuticals Europe Ltd

Sponsor details

c/o Dr Noreen O’Connor
Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom

Sponsor type

Industry

Website

http://www.sunovion.eu/

Funders

Funder type

Industry

Funder name

Sunovion Pharmaceuticals Europe Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

27/06/2016: No publications found, verifying study status with principal investigator.