NCT02454387

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Ono Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	ONO-4474 Part A1	Healthy volunteers
DRUG	Placebo Part A1	Healthy volunteers
DRUG	ONO-4474 Part A2	Healthy volunteers
DRUG	Placebo Part A2	Healthy volunteers
DRUG	ONO-4474 Part B	Healthy volunteers
DRUG	Placebo Part B	Healthy volunteers
DRUG	ONO-4474 Part C	Healthy volunteers
DRUG	Placebo Part C	Healthy volunteers
DRUG	ONO-4474 Part D	Healthy volunteers
DRUG	Placebo Part D	Healthy volunteers

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-05-27
• Last updated: 2016-06-30

Locations

2 sites across 2 countries: Denmark, United Kingdom