Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 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, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01364441
• Other study ID #: ONO-2952POU001
• Status: Completed
• Phase: Phase 1
• First received: May 25, 2011
• Last updated: June 12, 2012
• Start date: May 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-2952 across ascending single doses in healthy adult male and female subjects. The secondary objective is to characterize the pharmacokinetic (PK) profile of ONO-2952. The tertiary objective of this study is to preliminarily evaluate the effect of a meal upon the PK profile of ONO-2952.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. primary completion date: August 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 19-35 kg/m2 (inclusive)

• For females, surgically sterilized, postmenopausal, or who are non- lactating and agree to use a double barrier method of contraception

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-2952
3 mg to 800 mg at a single dose; 10 mg and 200 mg for food effect study
• Placebo
Placebo dosed in the same manner as ONO-2952

Locations

Country	Name	City	State
United States	Austin Clinical Site	Austin	Texas

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-2952 using vital signs, ECGs, laboratory tests, physical examinations, and incidence/severity of adverse events		up to 8 days	Yes
Secondary	Characterization of PK of ONO-2952 through measurement of drug concentration in plasma and urine sample		up to 8 days	No
Secondary	Effect of food on ONO-2952 pharmacokinetics by comparison of PK profile between fasted and fed conditions		up to 24 days	No