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Completed

NCT Number: NCT02454387

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

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

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Aalborg Clinical Site, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONO-4474 Part A1

Drug

Healthy volunteers

Other names: ONO-4474

Placebo Part A1

Drug

Healthy volunteers

Other names: Placebo

ONO-4474 Part A2

Drug

Healthy volunteers

Other names: ONO-4474

Placebo Part A2

Drug

Healthy volunteers

Other names: Placebo

ONO-4474 Part B

Drug

Healthy volunteers

Other names: ONO-4474

Placebo Part B

Drug

Healthy volunteers

Other names: Placebo

ONO-4474 Part C

Drug

Healthy volunteers

Other names: ONO-4474

Placebo Part C

Drug

Healthy volunteers

Other names: Placebo

ONO-4474 Part D

Drug

Healthy volunteers

Other names: ONO-4474

Placebo Part D

Drug

Healthy volunteers

Other names: Placebo

Primary outcomes

  1. Safety and tolerability of ONO-4474 across ascending single and multiple doses using number of adverse events

    Time frame: Up to Day 28

Secondary outcomes

  1. Maximum plasma concentration of ONO-4474 (Cmax)

    Time frame: Day 1 and at Day 7

  2. ONO-4474 Plasma Area Under the Curve from Time Zero to 24 hour after dosing (AUC24)

    Time frame: Day 1 and at Day 7

  3. Time to Reach Maximum Observed Plasma concentration (Tmax) of ONO-4474

    Time frame: Day 1 and at Day 7

  4. Plasma Decay half life (T1/2) of ONO-4474

    Time frame: Day 1 and at Day 7

  5. Part C only - Evaluation of ONO-4474 vs. placebo on walking soreness using a Likert scale

    Time frame: 3hr and 24hr after NGF injection

  6. Part C only: Assessment of pharmacology of ONO-4474 using change in pressure pain threshold after NGF injection.

    Time frame: 3hr and 24hr after NGF injection

    Pressure algometry at site of NGF injection (anterior tibialis)

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 27, 2015
Registry last updated
Jun 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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