We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01297582
First Posted: February 17, 2011
Last Update Posted: June 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
  Purpose
The primary objective of this study is to evaluate the safety and tolerability of ONO-6950 across ascending single doses in healthy adult male and female subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-6950 by measuring plasma concentrations of ONO-6950, pulmonary function, and potential cardiovascular effects. The tertiary objective of this study is to evaluate the effect of a meal upon the pharmacokinetic profile of ONO-6950.

Condition Intervention Phase
Healthy Adult Subjects Drug: ONO-6950 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Single-Dose Escalation and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects

Further study details as provided by Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc ):

Primary Outcome Measures:
  • Safety and tolerability of ONO-6950 using vital signs, pulmonary function tests, ECGs, laboratory tests, physical examinations [ Time Frame: up to 7 days ]

Secondary Outcome Measures:
  • Characterization of PK and PD profiles of ONO-6950, including change from baseline in pulmonary function tests, and any potential cardiovascular effects [ Time Frame: up to 7 days ]
  • Effect of food on ONO-6950 pharmacokinetics by comparison of PK profile between fasted and fed conditions [ Time Frame: up to 15 days ]

Enrollment: 56
Study Start Date: January 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E Drug: ONO-6950
1mg, 3mg, 10mg, 30mg,100mg,300mg,1000mg at a single dose; 30mg, 100mg and 300mg for food effect study
Placebo Comparator: P Drug: ONO-6950
1mg, 3mg, 10mg, 30mg, 100mg, 300mg, 1000mg at a single dose; 30mg, 100mg and 300mg for food effect study

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • History or presence of clinical significant disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297582


Locations
United States, Florida
Miramar Clinical Site
Miramar, Florida, United States, 33025
Sponsors and Collaborators
Ono Pharma USA Inc
Investigators
Study Director: Ono Pharma USA, Inc. Ono Pharmaceutical Co. Ltd
  More Information

Responsible Party: Ono Pharma USA Inc
ClinicalTrials.gov Identifier: NCT01297582     History of Changes
Other Study ID Numbers: ONO-6950POU001
First Submitted: February 11, 2011
First Posted: February 17, 2011
Last Update Posted: June 14, 2012
Last Verified: June 2012

Keywords provided by Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc ):
ONO-6950
Healthy Adult Subjects