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

Healthy Adult Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405651
• Other study ID #: ONO-6950POU002
• Status: Completed
• Phase: Phase 1
• First received: July 22, 2011
• Last updated: June 12, 2012
• Start date: July 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. primary completion date: October 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 10-35 kg/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

• Healthy Adult Subjects

Intervention

Drug:
• ONO-6950
30 mg, 100 mg, 300 mg at multiple doses
• ONO-6950
Placebo to match ONO-6950 tablets dosed in a similar manner to ONO-6950

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 and physical examinations		At protocol-specified timepoints before and after study drug administration up to 21 days	Yes
Secondary	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		At protocol-specified timepoints before and after study drug administration up to 21 days	Yes