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Clinical Trials/NCT01364441
NCT01364441
Completed
Phase 1

A Double-Blind, Placebo-Controlled, Single-Dose Escalation and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects

Ono Pharma USA Inc1 site in 1 country48 target enrollmentMay 2011
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ConditionsHealthy Adult Subjects
InterventionsPlaceboONO-2952
DrugsONO-2952Placebo

Overview

Phase
Phase 1
Intervention
Placebo
Conditions
Healthy Adult Subjects
Sponsor
Ono Pharma USA Inc
Enrollment
48
Locations
1
Primary Endpoint
Safety and tolerability of ONO-2952 using vital signs, ECGs, laboratory tests, physical examinations, and incidence/severity of adverse events
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 2011
End Date
August 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Healthy non-smoking male or female subjects (18-55 inclusive)
  • •Body mass index (BMI) of 19-35 kg/m2 (inclusive)
  • •For females, surgically sterilized, postmenopausal, or who are non- lactating and agree to use a double barrier method of contraception

Exclusion Criteria

  • •History or presence of clinically significant disease

Arms & Interventions

P

Intervention: Placebo

E

Intervention: ONO-2952

Outcomes

Primary Outcomes

Safety and tolerability of ONO-2952 using vital signs, ECGs, laboratory tests, physical examinations, and incidence/severity of adverse events

Time Frame: up to 8 days

Secondary Outcomes

  • Characterization of PK of ONO-2952 through measurement of drug concentration in plasma and urine sample(up to 8 days)
  • Effect of food on ONO-2952 pharmacokinetics by comparison of PK profile between fasted and fed conditions(up to 24 days)

Study Sites (1)

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