Study to assess the safety, tolerability and pharmacokinetics of DSP-2230 in humans

Phase 1

Completed

• Conditions: Peripheral neuropathic pain; Signs and Symptoms

• Registration Number: ISRCTN07951717
• Lead Sponsor: Sunovion Pharmaceuticals Europe Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-23
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 156

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures