Peripheral Neuropathic Pain Nervous System Diseases
Conditions
Interventions
Up to 44 subjects will be enrolled and randomised to receive DSP-2230 or placebo in a 1:1 ratio.
Subjects randomised to DSP-2230: 400 mg DSP-2230 suspension (single dose on Day 1), 80
single dose Day 14)
Subjects randomised to placebo: Placebo suspension.
On days -1, 1 and 13, Para-Amino Hippurate (PAH) will be used to measure effective renal plasm
Sponsors
Sunovion Pharmaceuticals Europe Ltd (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. All subjects (males) will be in good health aged = 18 and = 55 years with no evidence of systemic disease 2. Be able to comply with all aspects of the protocol 3. Able to give written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. All subjects will not have, or have had a history of, clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological or other major disorders 2. They will not have, or have had a history of, drug or alcohol abuse 3. Will not have participated in a clinical study with an investigational medicinal product (IMP) within 3 months of randomisation into the current study 4. Will not have donated or lost >500 mL of blood or blood products in the 3 months preceding the start of dosing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the PD of DSP-2230 using the GFR measured by iohexol plasma clearance. The primary PD endpoint is the glomerular filtration rate (GFR) measured by iohexol clearance on days -1 (baseline) and on day 1 (after a single dose of DSP2230 or placebo) and day 13 (after multiple dosing of DSP-2230 or placebo). | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic endpoints: The secondary PD endpoints comprise the following: 1. Renal plasma flow measured by para-amino hippurate (PAH) clearance 2. Urinary and plasma creatinine levels 3. Symmetrical dimethyl arginine (SDMA) 4. Cystatin-C Pharmacokinetic endpoints: The plasma concentration time profile and PK parameters of DSP-2230 will be determined from plasma samples collected on Day 1 (single dose) and Day 14 (multiple doses). Safety endpoints: Safety and tolerability will be assessed using the following endpoints: 1. Adverse events (AEs) and serious AEs (SAEs) 2. Vital signs 3. Electrocardiogram (ECG) and ECG time intervals 4. Clinical chemistry and haematology 5. Urinalysis including biomarkers of renal function The secondary PD endpoint is the renal plasma flow measured by PAH clearance and the tubular secretion of creatinine on days -1 (baseline) and on day 1 (after a single dose of DSP-2230 or placebo) and day 13 (after multiple dosing of DSP-2230 or placebo). In addition, safety endpoints AEs, vital signs, ECG and ECG time intervals, clinical chemistry including serum creatinine, haematology and urinalysis including biomarkers of renal function, will be measured after single and 13 days multiple dosing of DSP-2230 or placebo. | — |
Countries
United Kingdom
Outcome results
None listed