ONO-7746 Study in Healthy Adult Subjects

A Double-Blind, Placebo-Controlled, SIngle Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-7746 in Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00956371

Enrollment

Registered

2009-08-11

Start date

2009-08-31

Completion date

Unknown

Last updated

2012-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult Subjects

Keywords

ONO-7746, Healthy adult subjects

Brief summary

The primary objective of this study is to evaluate the safety and tolerability of ONO-7746 in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-7746.

Interventions

DRUGONO-7746

5mg, 10mg, 20mg, 50mg, 100mg, 200mg, 400mg, 800mg, 1200mg QD/1 day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* History or presence of clinically significant disease

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of ONO-7746 across ascending single doses	study duration

Secondary

Measure	Time frame
Characterization of PK and PD profiles of ONO-7746	study duration

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026