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

NCT01364441 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2012-06-13

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the safety and tolerability of ONO-2952 across ascending single doses in healthy adult male and female subjects. The secondary objective is to characterize the pharmacokinetic (PK) profile of ONO-2952. The tertiary objective of this study is to preliminarily evaluate the effect of a meal upon the PK profile of ONO-2952.

Conditions

  • Healthy Adult Subjects

Interventions

DRUG

ONO-2952

3 mg to 800 mg at a single dose; 10 mg and 200 mg for food effect study

DRUG

Placebo

Placebo dosed in the same manner as ONO-2952

Sponsors & Collaborators

  • Ono Pharma USA Inc

    lead INDUSTRY

Principal Investigators

  • Ono Pharma USA, Inc. · Ono Pharmaceutical Co. Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-08-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01364441 on ClinicalTrials.gov