NCT01106664

Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of NON-7746 in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-7746 and to evaluate the food effect on the PK profile of ONO-7746 when administered with or without a meal.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

7 months

First QC Date

April 13, 2010

Last Update Submit

June 12, 2012

Conditions

Healthy Adult Subjects

Keywords

ONO-7746Healthy adult subjects

Outcome Measures

Primary Outcomes (1)

  • Safety Assessment

    (evaluations of physical examinations, vital signs, 12-lead ECG, slit lamp examinations, safety laboratory tests, and surveillance for adverse events)

    up to 42 days

Secondary Outcomes (2)

  • Characterization of PK and PD profiles, including platelet count changes of ONO-7746

    up to 42 days

  • Effect of food on ONO-7746 pharmacokinetics

    up to 42 days

Study Arms (2)

P

PLACEBO COMPARATOR
Drug: ONO-7746

E

EXPERIMENTAL
Drug: ONO-7746

Interventions

ONO-7746DRUG

1mg, 2mg, 4mg, 8mg, 16mg, once daily for multiple-dose study; 4mg at a single dose for food effect study.

P

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy non-smoking male or female subjects (18-55 inclusive)
  • Body mass index (BMI) of 19-35 kg/m2 (inclusive)
  • For females, postmenopausal, non-lactating, and non-pregnant

You may not qualify if:

  • History or presence of clinically significant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Austin Clinical Site

Austin, Texas, 78744, United States

Location

Study Officials

  • Ono Pharma USA, Inc.

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2010

First Posted

April 20, 2010

Study Start

April 1, 2010

Primary Completion

November 1, 2010

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

US(1)