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

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.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN07951717

Enrollment

156

Registered

2012-05-23

Start date

2012-05-15

Completion date

Unknown

Last updated

2016-10-17

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: 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. Par

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
No secondary outcome measures	—

Countries

United Kingdom

Outcome results

None listed

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