Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects

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Ono Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Healthy Adult Subjects

Treatments

Drug: ONO-6950

Study type

Interventional

Funder types

Industry

Identifiers

NCT01297582
ONO-6950POU001

Details and patient eligibility

About

The primary objective of this study is to evaluate the safety and tolerability of ONO-6950 across ascending single doses in healthy adult male and female subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-6950 by measuring plasma concentrations of ONO-6950, pulmonary function, and potential cardiovascular effects. The tertiary objective of this study is to evaluate the effect of a meal upon the pharmacokinetic profile of ONO-6950.

Enrollment

56 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 19-35kg/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

56 participants in 2 patient groups, including a placebo group

E
Experimental group
Treatment:
Drug: ONO-6950
P
Placebo Comparator group
Treatment:
Drug: ONO-6950

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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