DSP-2230 Capsaicin and UVB Challenge Study

A randomised, double-blind, placebo-controlled, four-way crossover, two-part study investigating the pharmacodynamic effect of DSP-2230 using the ID Capsaicin and UVB models in healthy male subjects, using pregabalin and ibuprofen lysine as positive controls.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN80154838

Enrollment

Registered

2012-12-17

Start date

2013-01-07

Completion date

Unknown

Last updated

2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Neuropathic Pain Signs and Symptoms

Interventions

Part 1 - ID capsaicin model: ID capsaicin 100mg administered ID in 100ml of solution. Pregabalin 300 mg orally administered. Pregabalin placebo orally administered. The DSP-2230 placebo oral suspensi

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: All subjects (males) will be in good health aged 18 - 55 years with no evidence of systemic disease and be able to comply with all aspects of the protocol and able to give written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 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. They will not have, or have had a history of, drug or alcohol abuse and will not have participated in a clinical study with an investigational medicinal product (IMP) within 3 months of randomisation into the current study and 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
Safety: Parts 1 and 2: Adverse events (AEs), serious AEs (SAEs), vital signs, electrocardiogram (ECG) and ECG time intervals, clinical chemistry, haematology and urinalysis including biomarkers of renal function. Pharmacodynamic: Part 1 - ID capsaicin model: Subjective rating of pain using a visual analogue scale (VAS), area of punctate hyperalgesia, area of brush-evoked allodynia, area of vascular flare using laser Doppler flowmetry, intensity and area of cutaneous blood flow using laser Doppler flowmetry. Part 2 - UVB model: Heat pain detection threshold (HPDT), heat pain tolerance threshold (HPTT), area of vascular flare using laser Doppler flowmetry, intensity and area of cutaneous blood flow using laser Doppler flowmetry. Pharmacokinetic: Parts 1 and 2: Plasma single dose PK of DSP-2230 and its metabolite	—

Measure

Time frame

Safety: Parts 1 and 2: Adverse events (AEs), serious AEs (SAEs), vital signs, electrocardiogram (ECG) and ECG time intervals, clinical chemistry, haematology and urinalysis including biomarkers of renal function. Pharmacodynamic: Part 1 - ID capsaicin model: Subjective rating of pain using a visual analogue scale (VAS), area of punctate hyperalgesia, area of brush-evoked allodynia, area of vascular flare using laser Doppler flowmetry, intensity and area of cutaneous blood flow using laser Doppler flowmetry. Part 2 - UVB model: Heat pain detection threshold (HPDT), heat pain tolerance threshold (HPTT), area of vascular flare using laser Doppler flowmetry, intensity and area of cutaneous blood flow using laser Doppler flowmetry. Pharmacokinetic: Parts 1 and 2: Plasma single dose PK of DSP-2230 and its metabolite

—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026