Clinical Trials Logo
  1. Home
  2. Healthy Adult Subjects
  3. NCT01297582
  4. Details
NCT01297582 Clinical Trial

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

Healthy Adult Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01297582
Other study ID # ONO-6950POU001
Secondary ID
Status Completed
Phase Phase 1
First received February 11, 2011
Last updated June 12, 2012
Start date January 2011

Study information
Verified date June 2012
Source Ono Pharmaceutical Co. Ltd
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ONO-6950
1mg, 3mg, 10mg, 30mg,100mg,300mg,1000mg at a single dose; 30mg, 100mg and 300mg for food effect study
• ONO-6950
1mg, 3mg, 10mg, 30mg, 100mg, 300mg, 1000mg at a single dose; 30mg, 100mg and 300mg for food effect study

Locations
Country Name City State
United States Miramar Clinical Site Miramar Florida

Sponsors (1)
Lead Sponsor Collaborator
Ono Pharma USA Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability of ONO-6950 using vital signs, pulmonary function tests, ECGs, laboratory tests, physical examinations up to 7 days Yes
Secondary Characterization of PK and PD profiles of ONO-6950, including change from baseline in pulmonary function tests, and any potential cardiovascular effects up to 7 days Yes
Secondary Effect of food on ONO-6950 pharmacokinetics by comparison of PK profile between fasted and fed conditions up to 15 days No
See also
  Status Clinical Trial Phase
Completed NCT03267732 - A Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518) Phase 1
Completed NCT05040113 - A Study On Human Mass Balance And Biotransformation Phase 1
Completed NCT01433835 - Safety and Pharmacokinetics of Single Oral Doses of MBX-400 in Healthy Volunteers Phase 1
Completed NCT04029090 - A Study to Evaluate the Effect of MCI-186 at Therapeutic and Supra-Therapeutic Doses on the QT Interval(QT)/Corrected QT Interval(QTc) Interval in Healthy Subjects Phase 1
Completed NCT04586985 - Safety, Tolerability and Pharmacokinetics of FTX-6058 Phase 1
Completed NCT04481789 - Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study) Phase 1
Completed NCT06107205 - Bioequivalence of TTYP01 Tablets in Healthy Adult Subjects Phase 1
Completed NCT04629131 - Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TNM002 in Healthy Adults Phase 1
Recruiting NCT06063291 - Single Ascending Oral Dose Phase 1 Study of ID110521156 in Healthy Adult Subjects Phase 1
Completed NCT04203862 - A Study of NPC-22 in Healthy Adult Males Phase 1
Recruiting NCT05641181 - A Trial of CRB4101 in Healthy Subjects Phase 1
Completed NCT04521192 - Bioequivalence of Fluzoparib(SHR3162) Study on Healthy Chinese Adult Subjects Phase 1
Completed NCT04400123 - A Bioequivalence Study of Famitinib Malate on Healthy Chinese Volunteers Phase 1
Completed NCT04811469 - Safety, Tolerability and Pharmacokinetics of CBP-174 in Healthy Adults Phase 1
Completed NCT04291846 - A Food Effect Study of SHR1459 on Healthy Chinese Adult Subjects Phase 1
Completed NCT01364441 - Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects Phase 1
Completed NCT02691702 - Multiple Dose Study Of BIIB118 (PF-05251749) In Healthy Volunteers Phase 1
Recruiting NCT05334043 - Pharmacokinetics and Bioavailability of Curcumin UP 30 Capsules in Healthy Adult Subjects Phase 1
Completed NCT04493281 - Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects Phase 1
Completed NCT01376063 - Study to Investigate the Interaction Between FG-4592 and Rosiglitazone in Healthy Adult Subjects Phase 1