Osteoarthritis
Conditions
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.
Interventions
DRUGONO-4474 Part A1
Healthy volunteers
DRUGPlacebo Part A1
Healthy volunteers
DRUGONO-4474 Part A2
Healthy volunteers
DRUGPlacebo Part A2
Healthy volunteers
DRUGONO-4474 Part B
Healthy volunteers
DRUGPlacebo Part B
Healthy volunteers
DRUGONO-4474 Part C
Healthy volunteers
DRUGPlacebo Part C
Healthy volunteers
DRUGONO-4474 Part D
Healthy volunteers
DRUGPlacebo Part D
Healthy volunteers
Sponsors
Ono Pharmaceutical Co. Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. 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) 2. Subjects with a body mass index of 18.0-30.0 kg/m2 inclusive
Exclusion criteria
1. Subjects who have a clinically relevant history or presence of any clinically significant disease or disorder 2. Current smokers or those that have smoked or used nicotine products within 6 months of the Screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of ONO-4474 across ascending single and multiple doses using number of adverse events | Up to Day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Maximum plasma concentration of ONO-4474 (Cmax) | 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) |
| Plasma Decay half life (T1/2) of ONO-4474 | Day 1 and at Day 7 | — |
Countries
Denmark, United Kingdom
Outcome results
None listed