ONO-7746 Study in Healthy Adult Subject

Healthy Adult Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106664
• Other study ID #: ONO-7746POU002
• Status: Completed
• Phase: Phase 1
• First received: April 13, 2010
• Last updated: June 12, 2012
• Start date: April 2010

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 NON-7746 in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-7746 and to evaluate the food effect on the PK profile of ONO-7746 when administered with or without a meal.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. primary completion date: November 2010
• 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 19-35 kg/m2 (inclusive)

• For females, postmenopausal, non-lactating, and non-pregnant

Exclusion Criteria:

• History or presence of clinically 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-7746
1mg, 2mg, 4mg, 8mg, 16mg, once daily for multiple-dose study; 4mg at a single dose for food effect study.
• ONO-7746
1mg, 2mg, 4mg, 8mg, 16mg once daily for multiple-dose study; 4mg at a single dose for food effect study

Locations

Country	Name	City	State
United States	Austin Clinical Site	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Assessment	(evaluations of physical examinations, vital signs, 12-lead ECG, slit lamp examinations, safety laboratory tests, and surveillance for adverse events)	up to 42 days	Yes
Secondary	Characterization of PK and PD profiles, including platelet count changes of ONO-7746		up to 42 days	Yes
Secondary	Effect of food on ONO-7746 pharmacokinetics		up to 42 days	No