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

Ono Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Subjects

Treatments: Drug: ONO-6950

Study type: Interventional

Funder types: Industry

Identifiers

NCT01405651

ONO-6950POU002

Details and patient eligibility

About

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.

Enrollment: 24 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 10-35 kg/m2 (inclusive)
• For females; postmenopausal, non-lactating, and non-pregnant

Exclusion criteria

• History or presence of clinical significant disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

E

Experimental group

Description:

ONO-6950

Treatment:

Drug: ONO-6950

Drug: ONO-6950

P

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: ONO-6950

Drug: ONO-6950