Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00956371
NCT00956371CompletedPhase 1

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

Ono Pharmaceutical Co. Ltd1 site in 1 country48 target enrollmentStarted: August 2009Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
48
Locations
1
Primary Endpoint
Safety and tolerability of ONO-7746 across ascending single doses
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts 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

Arms & Interventions

P

Placebo Comparator

Intervention: ONO-7746 (Drug)

E

Experimental

Intervention: ONO-7746 (Drug)

Outcomes

Primary Outcomes

Safety and tolerability of ONO-7746 across ascending single doses

Time Frame: study duration

Secondary Outcomes

  • Characterization of PK and PD profiles of ONO-7746(study duration)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 1
ONO-7746 Study in Healthy Adult SubjectHealthy Adult Subjects
NCT01106664Ono Pharmaceutical Co. Ltd72
Completed
Phase 1
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult SubjectsHealthy Adult Subjects
NCT01297582Ono Pharma USA Inc56
Completed
Phase 1
Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult SubjectsHealthy Adult Subjects
NCT01364441Ono Pharma USA Inc48
Completed
Phase 1
Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult SubjectsHealthy
NCT01489345Ono Pharma USA Inc36
Completed
Phase 1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult SubjectsHealthy Adult Subjects
NCT01405651Ono Pharma USA Inc24
ONO-7746 Study in Healthy Adult Subjects | Clinical Trial