A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of ONO-4474 in Healthy Volunteers

Osteoarthritis Clinical Trial

Official title:

A Double-blind, Single and Multiple Ascending Dose, Randomised, Placebo-controlled Study, in Healthy Adult and Elderly Subjects Exploring Safety, Tolerability, Pharmacokinetics of ONO-4474 and Pharmacology of ONO-4474 in NGF-hyperalgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02454387
• Other study ID #: ONO-4474-01
• Status: Completed
• Phase: Phase 1
• First received: April 29, 2015
• Last updated: June 29, 2016
• Start date: May 2015
• Est. completion date: April 2016

Study information

• Verified date: January 2016
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyDenmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial Summary

A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of ONO-4474 in healthy volunteers.

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 information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• ONO-4474 Part A1
Healthy volunteers
• Placebo Part A1
Healthy volunteers
• ONO-4474 Part A2
Healthy volunteers
• Placebo Part A2
Healthy volunteers
• ONO-4474 Part B
Healthy volunteers
• Placebo Part B
Healthy volunteers
• ONO-4474 Part C
Healthy volunteers
• Placebo Part C
Healthy volunteers
• ONO-4474 Part D
Healthy volunteers
• Placebo Part D
Healthy volunteers

Locations

Country	Name	City	State
Denmark	Aalborg Clinical Site	Aalborg
United Kingdom	Nottingham Clinical SIte	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

Denmark,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of ONO-4474 across ascending single and multiple doses using number of adverse events		Up to Day 28	Yes
Secondary	Maximum plasma concentration of ONO-4474 (Cmax)		Day 1 and at Day 7	No
Secondary	ONO-4474 Plasma Area Under the Curve from Time Zero to 24 hour after dosing (AUC24)		Day 1 and at Day 7	No
Secondary	Time to Reach Maximum Observed Plasma concentration (Tmax) of ONO-4474		Day 1 and at Day 7	No
Secondary	Plasma Decay half life (T1/2) of ONO-4474		Day 1 and at Day 7	No
Secondary	Part C only - Evaluation of ONO-4474 vs. placebo on walking soreness using a Likert scale		3hr and 24hr after NGF injection	No
Secondary	Part C only: Assessment of pharmacology of ONO-4474 using change in pressure pain threshold after NGF injection.	Pressure algometry at site of NGF injection (anterior tibialis)	3hr and 24hr after NGF injection	No