Study to assess the safety, tolerability and pharmacokinetics of DSP-2230 in humans
| ISRCTN | ISRCTN07951717 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07951717 |
| Secondary identifying numbers | D8450052 |
- Submission date
- 18/04/2012
- Registration date
- 23/05/2012
- Last edited
- 27/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
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
Contact information
Scientific
ICON Development Solutions
Skelton House
Manchester Science Park
Manchester
M15 6SH
United Kingdom
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format. Please use the contact details below to request a subject information sheet |
| 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. |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | DSP-2230 |
| Primary outcome measure | 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 study start date | 15/05/2012 |
| Completion date | 15/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Part 1: 72 subjects; Part 2: 12 subjects; Part 3: 72 subjects - Total 156 subjects. |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/05/2012 |
| Date of final enrolment | 15/01/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
M15 6SH
United Kingdom
Sponsor information
Industry
c/o Dr Noreen OConnor
Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom
| Website | http://www.sunovion.eu/ |
|---|---|
"ROR" |
https://ror.org/03sh4z743 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
27/06/2016: No publications found, verifying study status with principal investigator.
