NCT01909986

CompletedPhase 1

A Human Mass Balance Study to Determine the Total Recovery o...

Ono Pharmaceutical Co., Ltd.Source

Ono Pharmaceutical Co., Ltd.

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

ONO-4053POE004

Study Type

interventional

Actual enrollment (reported)

8

Locations

1 country

Sites

1

Timeline

Study Start

October 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2014

Actual (reported)

Study Completion

Not reported

Date not reported

Brief Summary

This is a single dose mass balance study in healthy adult male volunteers to investigate the metabolism and excretion of \[14C\]-ONO-4053.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 8 participants
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
July 8, 2013
Actual (reported)
First Posted
July 29, 2013
Actual (reported)
Study Start
October 2013
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
February 2014
Actual (reported)

Last Updated: April 15, 2014
Status Verified: July 2013
Last Update Submitted: April 14, 2014

Conditions

Healthy Adult Male Subjects

Keywords

ONO-4053Healthy adult male subjectspharmacokineticsmetabolismexcretionmass balance

Outcome Measures

Primary Outcomes (1)

[14C]ONO-4053 recovery
Total recovery of radioactivity in urine and faeces expressed as a percentage of the total radioactive dose administered
11 Days

Secondary Outcomes (6)

[14C]-ONO-4053 metabolites
11 Days
Total drug-related material
11 Days
ONO-4053 in plasma
11 Days
Blood:plasma ratio of [14C]ONO-4053
11 Days
Radioactivity in urine
11 Days
+1 more secondary outcomes

Study Arms (1)

E1

EXPERIMENTAL

\[14C\]-ONO-4053

Drug: [14C]ONO-4053

Interventions

[14C]ONO-4053Drug

Single dose \[14C\]ONO-4053

E1

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age35 Years - 65 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

The subject has provided written informed consent
Healthy male subjects aged 35 to 65 years inclusive

Sponsors & Collaborators

Ono Pharmaceutical Co., Ltd.
Industrylead

Study Sites (1)

Nottingham Clinical site

Nottingham, NG11 6JS, United Kingdom

Study Officials

Clinical Department
Ono Pharmaceutical Co., Ltd.
STUDY DIRECTOR

Enrollment

8 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 8, 2013

First Posted

July 29, 2013

Study Start

October 2013

Date type not reported

This date has not been verified as actual or estimated.

Subject is not trying to father a child and is willing to use one of the contraception methods listed in the protocol 4 The subject has a body mass index of 19.0 to 30.0 kg/m2 inclusive. 5 The subject is healthy as determined by the Investigator 6 Regular daily bowel movements

You may not qualify if:

The Investigator deems the subject unsuitable for the study
The subject has, or has a history of, any significant disease or disorder (including any clinically significant laboratory findings) that would increase the risk for the subject if they were enrolled in the study
The subject has a history of acute gastrointestinal illness
The subject has used prescription medicine, non-prescription medicine, vitamins, herbal treatments or dietary supplements within 14 days of dosing.
Current smokers and those who have smoked within the last 12 months
Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study.

Contact the study team to confirm eligibility.

Primary Completion

February 2014

Actual (reported)

Last Updated

April 15, 2014

Record last verified: 2013-07

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT01909986
Data provider: ClinicalTrials.gov
Source updated: 2014-04-15
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:51 UTC

Locations

GB(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

E1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations