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

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ClinicalTrials.gov Identifier: NCT01405651
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : June 14, 2012
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Adult Subjects Drug: ONO-6950 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects
Study Start Date : July 2011
Primary Completion Date : October 2011

Arm Intervention/treatment
Experimental: E
ONO-6950
Drug: ONO-6950
30 mg, 100 mg, 300 mg at multiple doses
Placebo Comparator: P
Placebo
Drug: ONO-6950
Placebo to match ONO-6950 tablets dosed in a similar manner to ONO-6950



Primary Outcome Measures :
  1. Safety and tolerability of ONO-6950 using vital signs, pulmonary function tests ECGs, laboratory tests and physical examinations [ Time Frame: At protocol-specified timepoints before and after study drug administration up to 21 days ]

Secondary Outcome Measures :
  1. Characterization of PK ( Cmax, Tmax, AUC, ty2, etc.) and PD profiles of ONO-6950 using plasma concentration of ONO-6950 in blood and pulmonary function tests [ Time Frame: At protocol-specified timepoints before and after study drug administration up to 21 days ]


Information from the National Library of Medicine

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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 10-35 kg/m2 (inclusive)
  • For females; postmenopausal, non-lactating, and non-pregnant

Exclusion Criteria:

  • History or presence of clinical significant disease

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): NCT01405651


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

Responsible Party: Ono Pharma USA Inc
ClinicalTrials.gov Identifier: NCT01405651     History of Changes
Other Study ID Numbers: ONO-6950POU002
First Posted: July 29, 2011    Key Record Dates
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