A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of ONO-4474 in Healthy Volunteers
Phase 1
Completed
- Conditions
- Osteoarthritis
- Interventions
- Drug: ONO-4474 Part A1Drug: ONO-4474 Part A2Drug: Placebo Part A2Drug: Placebo Part BDrug: Placebo Part A1Drug: Placebo Part CDrug: ONO-4474 Part BDrug: ONO-4474 Part DDrug: Placebo Part DDrug: ONO-4474 Part C
- Registration Number
- NCT02454387
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Brief Summary
A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of ONO-4474 in healthy volunteers.
- Detailed Description
A Double-blind, Multi-centre, Single Dose, Single and Multiple Ascending Dose, Four-part, Randomised, Placebo-controlled Study in Healthy Adult and Elderly Subjects Exploring the Safety, Tolerability, Pharmacokinetics of ONO-4474 in Fed and Fasted Conditions, and Pharmacology of ONO-4474 in NGF-hyperalgesia.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 141
Inclusion Criteria
- Healthy male subjects aged 18-55 years inclusive (Parts A and C); healthy male and female subjects aged 18-55 years inclusive (Part B); healthy male and female subjects aged 65 and over (Part D)
- Subjects with a body mass index of 18.0-30.0 kg/m2 inclusive
Exclusion Criteria
- Subjects who have a clinically relevant history or presence of any clinically significant disease or disorder
- Current smokers or those that have smoked or used nicotine products within 6 months of the Screening visit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Experimental: ONO-4474 Part A1 ONO-4474 Part A1 Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo Experimental: ONO-4474 Part A2 ONO-4474 Part A2 Single doses (2 periods) of ONO-4474 or placebo, randomized 3 active: 1 placebo Experimental: ONO-4474 Placebo Part A2 Placebo Part A2 Single doses (2 periods) of ONO-4474 or placebo, randomized 3 active: 1 placebo Experimental: ONO-4474 Placebo Part B Placebo Part B Multiple ascending doses of ONO-4474 or placebo, randomized 3 active: 1 placebo Experimental: ONO-4474 Placebo Part A1 Placebo Part A1 Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo Experimental: ONO-4474 Placebo Part C Placebo Part C NGF hyperalgesia and single or multiple doses of ONO-4474, randomized 1 active: 1 placebo in cross over design Experimental: ONO-4474 Part B ONO-4474 Part B Multiple ascending doses of ONO-4474 or placebo, randomized 3 active: 1 placebo Experimental: ONO-4474 Part D ONO-4474 Part D Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo Experimental: ONO-4474 Placebo Part D Placebo Part D Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo Experimental: ONO-4474 Part C ONO-4474 Part C NGF hyperalgesia and single or multiple doses of ONO-4474, randomized 1 active: 1 placebo in cross over design
- Primary Outcome Measures
Name Time Method Safety and tolerability of ONO-4474 across ascending single and multiple doses using number of adverse events Up to Day 28
- Secondary Outcome Measures
Name Time Method Maximum plasma concentration of ONO-4474 (Cmax) Day 1 and at Day 7 ONO-4474 Plasma Area Under the Curve from Time Zero to 24 hour after dosing (AUC24) Day 1 and at Day 7 Time to Reach Maximum Observed Plasma concentration (Tmax) of ONO-4474 Day 1 and at Day 7 Plasma Decay half life (T1/2) of ONO-4474 Day 1 and at Day 7 Part C only - Evaluation of ONO-4474 vs. placebo on walking soreness using a Likert scale 3hr and 24hr after NGF injection Part C only: Assessment of pharmacology of ONO-4474 using change in pressure pain threshold after NGF injection. 3hr and 24hr after NGF injection Pressure algometry at site of NGF injection (anterior tibialis)
Trial Locations
- Locations (2)
Nottingham Clinical SIte
🇬🇧Nottingham, United Kingdom
Aalborg Clinical Site
🇩🇰Aalborg, Denmark