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

Ono Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Subjects

Treatments: Drug: Placebo; Drug: ONO-2952

Study type: Interventional

Funder types: Industry

Identifiers

NCT01364441

ONO-2952POU001

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

P

Placebo Comparator group

Treatment:

Drug: Placebo

E

Experimental group

Treatment:

Drug: ONO-2952