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

Ono Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Osteoarthritis

Treatments: Drug: ONO-4474 Part A1; Drug: Placebo Part D; Drug: Placebo Part A1; Drug: Placebo Part B; Drug: ONO-4474 Part C; Drug: ONO-4474 Part A2; Drug: ONO-4474 Part D; Drug: Placebo Part A2; Drug: Placebo Part C; Drug: ONO-4474 Part B

Study type: Interventional

Funder types: Industry

Identifiers

NCT02454387

ONO-4474-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 141 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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141 participants in 10 patient groups, including a placebo group

Experimental: ONO-4474 Part A1

Experimental group

Description:

Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo

Treatment:

Drug: ONO-4474 Part A1

Experimental: ONO-4474 Placebo Part A1

Placebo Comparator group

Description:

Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo

Treatment:

Drug: Placebo Part A1

Experimental: ONO-4474 Part A2

Experimental group

Description:

Single doses (2 periods) of ONO-4474 or placebo, randomized 3 active: 1 placebo

Treatment:

Drug: ONO-4474 Part A2

Experimental: ONO-4474 Placebo Part A2

Placebo Comparator group

Description:

Single doses (2 periods) of ONO-4474 or placebo, randomized 3 active: 1 placebo

Treatment:

Drug: Placebo Part A2

Experimental: ONO-4474 Part B

Experimental group

Description:

Multiple ascending doses of ONO-4474 or placebo, randomized 3 active: 1 placebo

Treatment:

Drug: ONO-4474 Part B

Experimental: ONO-4474 Placebo Part B

Placebo Comparator group

Description:

Multiple ascending doses of ONO-4474 or placebo, randomized 3 active: 1 placebo

Treatment:

Drug: Placebo Part B

Experimental: ONO-4474 Part C

Experimental group

Description:

NGF hyperalgesia and single or multiple doses of ONO-4474, randomized 1 active: 1 placebo in cross over design

Treatment:

Drug: ONO-4474 Part C

Experimental: ONO-4474 Placebo Part C

Placebo Comparator group

Description:

NGF hyperalgesia and single or multiple doses of ONO-4474, randomized 1 active: 1 placebo in cross over design

Treatment:

Drug: Placebo Part C

Experimental: ONO-4474 Part D

Experimental group

Description:

Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo

Treatment:

Drug: ONO-4474 Part D

Experimental: ONO-4474 Placebo Part D

Placebo Comparator group

Description:

Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo

Treatment:

Drug: Placebo Part D