A Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of ONO-4053 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to evaluate the safety and tolerability of ONO-4053 across ascending single and multiple doses in healthy adult male and female subjects. The secondary objective of the study is to characterize the pharmacokinetic profile of ONO-4053 in healthy adult male and female subjects.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of ONO-4053 in Healthy Volunteers

NCT01537172

Healthy Adult Subjects

COMPLETED PHASE1

Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects

NCT01364441

Healthy Adult Subjects

COMPLETED PHASE1

ONO-7746 Study in Healthy Adult Subjects

NCT00956371

Healthy Adult Subjects

COMPLETED PHASE1

ONO-7746 Study in Healthy Adult Subject

NCT01106664

Healthy Adult Subjects

COMPLETED PHASE1

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects

NCT01297582

Healthy Adult Subjects

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a first-in-human study of ONO-4053 in healthy volunteers. This study consists of three parts. Part A will investigate the safety, tolerability and pharmacokinetics when single ascending doses of ONO-4053 are administered in a double-blind manner. Part B will investigate the pharmacokinetics of ONO-4053 in the fed and fasted state in an open-label manner. Part C will investigate the safety, tolerability and pharmacokinetics when multiple ascending doses of ONO-4053 are administered in a double-blind manner. Doses for Part B and C will be determined after data from Part A are available.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Adult Subjects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

E

ONO-4053

Group Type EXPERIMENTAL

ONO-4053

Intervention Type DRUG

Part A: ONO-4053 doses proposed are 1 mg, 3 mg, 10 mg, 30 mg, 100 mg, 300 mg, 600 mg as a single dose administered by mouth once daily

P

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to match ONO-4053 tablets dosed in a similar manner to ONO-4053

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ONO-4053

Part A: ONO-4053 doses proposed are 1 mg, 3 mg, 10 mg, 30 mg, 100 mg, 300 mg, 600 mg as a single dose administered by mouth once daily

Intervention Type DRUG

Placebo

Placebo to match ONO-4053 tablets dosed in a similar manner to ONO-4053

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy caucasian subjects aged 18-45 years inclusive
* Subjects with a body mass index of 19-30 kg/m2 inclusive and who weigh at least 50 kg and no more than 100 kg at screening.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes