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

June 29, 2016 updated by: Ono Pharmaceutical Co. Ltd

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

141

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Aalborg Clinical Site
  • United Kingdom
      • Nottingham, United Kingdom
        • Nottingham Clinical SIte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: ONO-4474 Part A1
Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo
Drug: ONO-4474 Part A1
Healthy volunteers
Other Names:
  • ONO-4474
Placebo Comparator: Experimental: ONO-4474 Placebo Part A1
Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo
Drug: Placebo Part A1
Healthy volunteers
Other Names:
  • Placebo
Experimental: Experimental: ONO-4474 Part A2
Single doses (2 periods) of ONO-4474 or placebo, randomized 3 active: 1 placebo
Drug: ONO-4474 Part A2
Healthy volunteers
Other Names:
  • ONO-4474
Placebo Comparator: Experimental: ONO-4474 Placebo Part A2
Single doses (2 periods) of ONO-4474 or placebo, randomized 3 active: 1 placebo
Drug: Placebo Part A2
Healthy volunteers
Other Names:
  • Placebo
Experimental: Experimental: ONO-4474 Part B
Multiple ascending doses of ONO-4474 or placebo, randomized 3 active: 1 placebo
Drug: ONO-4474 Part B
Healthy volunteers
Other Names:
  • ONO-4474
Placebo Comparator: Experimental: ONO-4474 Placebo Part B
Multiple ascending doses of ONO-4474 or placebo, randomized 3 active: 1 placebo
Drug: Placebo Part B
Healthy volunteers
Other Names:
  • Placebo
Experimental: Experimental: ONO-4474 Part C
NGF hyperalgesia and single or multiple doses of ONO-4474, randomized 1 active: 1 placebo in cross over design
Drug: ONO-4474 Part C
Healthy volunteers
Other Names:
  • ONO-4474
Placebo Comparator: Experimental: ONO-4474 Placebo Part C
NGF hyperalgesia and single or multiple doses of ONO-4474, randomized 1 active: 1 placebo in cross over design
Drug: Placebo Part C
Healthy volunteers
Other Names:
  • Placebo
Experimental: Experimental: ONO-4474 Part D
Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo
Drug: ONO-4474 Part D
Healthy volunteers
Other Names:
  • ONO-4474
Placebo Comparator: Experimental: ONO-4474 Placebo Part D
Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo
Drug: Placebo Part D
Healthy volunteers
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of ONO-4474 across ascending single and multiple doses using number of adverse events
Time Frame: Up to Day 28
Up to Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration of ONO-4474 (Cmax)
Time Frame: Day 1 and at Day 7
Day 1 and at Day 7
ONO-4474 Plasma Area Under the Curve from Time Zero to 24 hour after dosing (AUC24)
Time Frame: Day 1 and at Day 7
Day 1 and at Day 7
Time to Reach Maximum Observed Plasma concentration (Tmax) of ONO-4474
Time Frame: Day 1 and at Day 7
Day 1 and at Day 7
Plasma Decay half life (T1/2) of ONO-4474
Time Frame: Day 1 and at Day 7
Day 1 and at Day 7
Part C only - Evaluation of ONO-4474 vs. placebo on walking soreness using a Likert scale
Time Frame: 3hr and 24hr after NGF injection
3hr and 24hr after NGF injection
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)
3hr and 24hr after NGF injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharmaceutical Co. Ltd

Investigators

  • Study Director: Drug Development Division, Ono Pharmaceutical Co. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

April 29, 2015

First Submitted That Met QC Criteria

May 22, 2015

First Posted (Estimate)

May 27, 2015

Study Record Updates

Last Update Posted (Estimate)

June 30, 2016

Last Update Submitted That Met QC Criteria

June 29, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-4474-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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