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

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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

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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