Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Brief Summary

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The primary objective of this study is to evaluate the safety and tolerability of ONO-6950 across ascending multiple doses in healthy adult male and female subjects. The secondary objectives are to characterize the PK and pharmacodynamic (PD) profiles of ONO-6950 by measuring plasma concentrations of ONO-6950 and pulmonary function.

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Detailed Description

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Conditions

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Healthy Adult Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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E

ONO-6950

Group Type EXPERIMENTAL

ONO-6950

Intervention Type DRUG

30 mg, 100 mg, 300 mg at multiple doses

P

Placebo

Group Type PLACEBO_COMPARATOR

ONO-6950

Intervention Type DRUG

Placebo to match ONO-6950 tablets dosed in a similar manner to ONO-6950

Interventions

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ONO-6950

30 mg, 100 mg, 300 mg at multiple doses

Intervention Type DRUG

ONO-6950

Placebo to match ONO-6950 tablets dosed in a similar manner to ONO-6950

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy non-smoking male or female subjects (18-55 inclusive)
* Body mass index (BMI)of 10-35 kg/m2 (inclusive)
* For females; postmenopausal, non-lactating, and non-pregnant